Manufacturing/Mechanical Salary in Cambridge, MA

About the Traverso LabThe Traverso lab is focused on translational engineering with applications in medicine. Our main goal is to help people through the use of medicine and engineering. Research projects involve medical devices that can range from diagnostic, drug delivery, surgical, and implantable devices. Dr. Giovanni Traverso is a Physician-Scientist who is an Associate Professor at MIT Mechanical Engineering, and an Assistant Professor at Harvard Medical School and the Division of Gastroenterology at Brigham and Women's Hospital (BWH). This position will require direct on-boarding and will be stationed at a satellite facility of the Brigham and Women's Hospital in Cambridge, but will involve work with a multidisciplinary team from across the different MIT/Harvard/BWH institutions.Position Overview:In this role, you will focus on the design, fabrication, and testing of devices in the micro-size scale using a state-of-the-art cleanroom fabrication facility. This role will be part of the fabrication team comprised of mechanical engineers, electrical engineers, imaging specialists, and microfabrication and micro/nano technology experts. The work with this multidisciplinary group of researchers will cover design, fabrication, and testing of medical devices with a specific focus on novel drug delivery devices. The position also covers many aspects of design and fabrication including work with microfabrication (photolithography, thin film deposition, wet and dry chemical etching, metrology, packaging, 3D printers (SLA and FDM), Laser micromachining, and many other mechanical fabrication/testing equipment.Qualifications Responsibilities:• Work with postdocs to design prototype medical devices and drug delivery systems• Microfabrication of MEMS in a cleanroom facility • Formulate and perform chemical/mechanical characterization of polymeric materials for drug delivery• Execute statistical analysis of experiments• Summarize and document research results/findingsRequired Qualifications & Skills:Pursuing a research position post-graduation from a B.S or M.S., or equivalent in mechanical engineering, biomedical engineering, or a related field; at least 6 months of relevant experience (co-op and internships considered). An ideal candidate will have a research background in MEMS, microfabrication and mechanical/electrical engineering, as well as hands-on experience/rapid prototyping skills, but training to gain further skills will be available. Candidates with relevant experience in the following areas are encouraged to apply:• MEMS/NEMS devices• Microfabrciation (photolithography, thin film deposition, wet and dry chemical etching (RIE, DRIE), metrology (SEM, profilometer), Packaging. • CAD (L-Edit, SolidWorks)• Biomedical device design and development• Material characterization (biomaterials and plastics, experience with Instron testing machines)• Additive manufacturing/3D Printing (FDM and SLA)• Plastic injection molding (extrusion, injection molding, and compression molding)• Drug delivery/pharmaceutical sciences• Documentation skills and skills in writing standard operating procedures• Simulation (COMSOL) preferred• Matlab/Arduino programming preferred Candidate must have self-motivation and willingness to learn new tools and techniques; strong organizational, interpersonal, and communication skills; ability to work independently and as part of a team; comfort summarizing and reporting results to interdisciplinary researchers; commitment to exceeding standards and producing accurate, high-quality work; meticulous attention to detail; practiced documentation skills; and ability to follow safety procedures and maintain a safe work environment.EEO Statement BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Beacon Hill Life Sciences is actively recruiting for a Senior Manager of GCP Quality Assurance to work a contract assignment, part-time hours. Hours: Part-time, approximately 20 hours per weekDuration of assignment: 6 months with possibility of extensionFully remote is possible, preference is hybrid (Location: Cambridge, MA)Pay Rate is based on experience with range being $100 - $125/hourSummary: The Sr Manager, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as varied vendors supporting Clinical Studies.This is a high visibility role and will be directly involved in development and continuous improvement of GCP Quality and overall Quality Management Systems. This individual will be responsible for coordinating with key stakeholders to develop/implement processes and systems governing GCP activities. Will be Subject Matter Expert in GCP Compliance with respect to planning, execution, and close-out Clinical Studies.Responsibilities include: Oversight of ongoing compliance of Clinical Studies. Act as GCP QA Program Lead while working with internal customers to ensure overall compliance from risk-based principles. Work with internal and external GCP customers and develop and execute strategic plans to identify, mitigate, monitor and report study risks and Quality Tolerance Limits on a per study basis. Assist in resolving compliance issues at clinical sites, clinical vendors, and laboratories and provide assessment of the impact of any deficiencies. Escalate issues through the Quality Organization as needed.GCP Vendor Audits and Oversight. Support the GCP Vendor Audit Schedule including CRO, Central and Specialty Laboratories, IxRS/IRT/Randomization liaising with QA Vendor Auditing. Coordinate with Study Team members to ensure vendor audits are appropriately scoped and that third-party auditors are provided all the documentation and insights required for successful audit execution. Review and approve submitted audit reports. Ensure audits were performed to internal standards. Ensure proposed CAPAs are adequate and executed properly.Clinical Investigator Site Audits. Manage the Clinical Investigator (CI) Site Audit program for assigned studies. Coordinate with Study Team members to determine CI sites to be audited per study via risk-based criteria. Coordinate with Study Team members and third-party auditors to ensure CI site audits are appropriately scoped and audit planned. Review and approve submitted audit reports. Ensure audits were performed to internal standards. Ensure proposed CAPAs are adequate and track to closure. Determine if CI Site audit observations may represent study-wide or program-wide risks and ensure Impact/Risk Assessments and Study-wide/Program-wide CAPAs are adequate.Quality Management System. Coordinate with Program Leads, Biostatistics, Data Management, Medical Affairs, Pharmacovigilance to develop/implement Phase appropriate procedures to ensure consistency and quality with respect to Clinical Trial support activities. Perform internal audits of processes and functional areas to ensure compliance with GCP, internal SOPs and other applicable regulations. Coordinate with Senior Management, Functional Area Leads, and third-party vendors, to plan and execute resolution to compliance gaps identified during mock inspections.Candidate Requirements:Bachelor's degree in the Life Sciences with 7+ years in pharmaceutical or biotech drug development. Advanced degree preferred.Minimum 3 years of experience in Clinical QA. Experience in auditing both Vendors and Clinical Investigator Sites a plus. Experience helping with phase 3 registrational study preferred. Demonstrated experience working with clinical trial teams.Extensive experience with Global Clinical trial conduct, knowledge and understanding of ICH E6 (R2) GCP Guideline, FDA Regulations and EU Requirements.Ability to evaluate and reorganize priorities quickly in a dynamic matrixed setting.Excellent interpersonal skills, personal integrity, professional manner and ability to gain respect and develop good working relationship with cross functional personnel at all levels.Experience helping with phase 3 registrational study preferred.Must be organized and ability to multi-task with multitude of different pieces.Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records. Company Profile:Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.beaconhillstaffing.com . We look forward to working with you!Beacon Hill. Employing the Future™

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Production professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to Operations Management at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.POSITION SUMMARY The Production Scheduler plays a pivotal role in optimizing the operational efficiency of our facility by strategically establishing site and department capacities. This includes the development and management of daily, weekly, monthly, and quarterly production schedules. Collaborating closely with cross-functional management, this position champions a culture of continuous improvement, transparency, and effective communication throughout the organization. This position drives our commitment to operational excellence and contribute to the overall success of our commercial operations.DUTIES AND RESPONSIBILITIES Essential Functions: Establish capacity modeling for the operations organization which will determine the production schedule.Create, confirm, and maintain operations production schedule for multiple product lines, Quality Control, Quality Assurance, Material Handlers using the Preactor scheduling software program.Assess customer orders, available staff, equipment and cellular inventory to effectively set and simultaneously manage production schedules for operations.Plan daily, weekly, and monthly operations schedules and the associated resource allocation.Constantly monitor, assess and when necessary, provide recommendations to improve the effectiveness and functionality of the scheduling software (e.g., beneficial reports, updates for new activities, etc.).Support and participate in scheduling related projects and key initiatives that directly support the operations departments, including resource planning of labor, materials, and equipment.Perform sales order support using the ERP, scheduling, and CRM systems.May provide support for inventory management and control within ERP and MES systems.Serve as a liaison between all departments within Operations.Other duties as assigned.Leadership Responsibilities: Understanding, observing, and adhering to the goals and policies outlined in Vericel's Code of Business Conduct and EthicsBeing honest and treating people with respect and courtesy.Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.QUALIFICATIONS, EDUCATION AND EXPERIENCE Basic Qualifications: Bachelor's degree plus 4+ years of experience with manufacturing operations scheduling.Associate degree plus 6+ years of experience with manufacturing operations scheduling, or 8+ years of scheduling experience with GED or equivalent.Excellent communication skills, written and verbal.Advanced to expert level ability with Microsoft office.Experience with ERP, MES, CRM and scheduling systems (e.g., Microsoft Dynamics GP, MFG/Pro, SAP, Preactor, etc.).Preferred Qualifications: Lean manufacturing experienceExperience with Industrial Engineering capacity modelingExperience in cGMP production environments.Experience working within a regulated environment that is frequently audited by internal and external Agencies, such as the FDA and ISO.Proven analytical, problem solving and facilitation skillsWORKING CONDITIONS AND PHYSICAL DEMANDS May be required to work 2nd shift Sunday - Wednesday or Wednesday - Saturday fixed shift.Rotating holiday coverageEEO StatementAll applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Are you interested in joining our team? Chat with our digital assistant to learn more about our company and apply right from your mobile device!Text ETP to 25000 to get started or apply through this web posting if you prefer.Energy Transfer, recognized by Forbes as one of America's best large employers, is dedicated to responsibly and safely delivering America’s energy. We are driven to inspire our employees to create superior value for our customers and investors, a sustainable future, and give back to the community where we have long-standing commitments to causes including MD Anderson Children’s Cancer Hospital, The Salvation Army, American Heart Association, Ronald McDonald House, and many more.We value all of our employees, who make our growth and success possible. We are proud to offer industry-leading compensation, comprehensive benefits, a 401 (k) match with additional profit sharing, PTO, and abundant career opportunities.Come join our award-winning, 11,000-strong organization as we fuel the world and each other!Summary:This position is responsible for the repair and maintenance of pipelines, equipment and performance of work associated with daily operation and maintenance of gas and liquid facilities and pipelines.Essential Duties and Responsibilities:To perform this job successfully, an individual must be able to perform each essential job duty satisfactorily. The essential job duties for this position are listed below:Inspect, maintain, troubleshoot, repair, and operate compressor station or pump station equipment, plant facilities and pipeline facilities including: prime movers and compressors, valves, filters, separators, dehydrators, pumps, and auxiliary equipment in order to meet production and product throughput requirements in a reliable and efficient manner while in compliance with the Partnership’s procedures and regulatory requirementsPlan, organize, prioritize, communicate, and coordinate work with employees and contractors to validate the work is completed in a safe, timely, and effective mannerProvide budgetary information, schedule work and outages, order materials, maintain inventory, and coordinate needed resourcesInterpret and utilize drawings, schematics, loading/pump curves, OEM manuals, and other technical resources in the performance of assigned workEffectively and safely use hand tools, power tools, and portable and mobile work equipment in hazardous, classified, and non-hazardous environmentsUtilize precision measurement equipment to determine dimensions and set operating equipment clearances and tolerancesMaintain equipment records, logs, inventory, and other documentation required by the Partnership’s procedures and regulatory agenciesProvide training and leadership to develop and maintain effective work crews, dependent upon level hiredMaintain working knowledge of regulatory requirements, perform associated required tasks, and complete required documentation (OSHA, DOT, EPA, etc.)Maintain facilities, grounds, and work areas in a safe, orderly, and efficient mannerActively participate and provide leadership in safety programs and initiatives while following policies and proceduresProvide on-call support for areas of responsibility on a rotating basisComply with partnership safety policies and proceduresPerform energy isolation lockout/tagout procedures (LOTO)Required Education:High school diploma or GEDRequired experience is commensurate with the selected job level:Level C requires a minimum of 0 2 years of relevant industry experience or equivalent work experienceLevel B requires a minimum of 2 4 years of relevant industry experience or equivalent work experienceLevel A requires a minimum of 4+ years of relevant industry experience or equivalent work experienceRequired Qualifications:Valid driver’s license with demonstrated safe driving record and ability to be certified as a USDOT driver under FMCSA may be required based on applicable law, reporting location, and geographic work areaExcellent organizational skillsExcellent written and verbal communication skills with the ability to work effectively in a group environmentDemonstrated self- starter with the ability to work independently and exercise good judgementPreferred Qualifications:Mechanical aptitude with ability to learn and perform operation and maintenance tasks associated with various types of facilities and equipmentProficiency with computers including MS Office applications such as Excel and Outlook as well as other computer based work training, time reporting, expense reporting, and on-line work applications and documentationWorking Conditions and Requirements:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.Occasional exposure to heat, cold, and other adverse weather conditionsWork may include confined spaces and may require heavy lifting in excess of 75 lbs with or without assistanceWork in and around industrial and construction settings, which may include hazardous products, processes, materials and chemicals, as well as extreme temperature conditions and loud machinery, and may require appropriate personal protective equipment (which may include, but may not be limited to, necessary respirators)Work on and around equipment and facilities that require knowledge of and adherence to safe work procedures and practicesSubject to call-outs to respond to operational issues and emergencies after working hours, at night, and on weekends and holidaysReliable attendance at workOccasional overnight travel may be requiredEqual Opportunity Employer/Minority/Female/Disabled/VeteranThe nature and frequency of the above working conditions and requirements may vary depending on individual operational circumstances. Where feasible, the Partnership will make reasonable accommodations to qualified individuals with disabilities to enable them to perform the essential functions of the job.DISCLAIMER:The above statements, which are subject to change, are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of personnel so classified.#LI-CK1An equal opportunity employer/disability/vetEnergy Transfer is an equal opportunity employer and does not discriminate against qualified applicants on the basis of actual or perceived race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, pregnancy, veteran status, genetic information, citizenship status, or any other basis prohibited by law.The nature and frequency of the above working conditions and requirements may vary depending on individual operational circumstances. Where feasible, the Partnership will make reasonable accommodations to qualified individuals with disabilities to enable them to perform the essential functions of the job.DISCLAIMER: The statements listed in this job posting, which are subject to change, are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of personnel so classified.

Title: EngineerLocation: Cambridge, MA Duration: 12+MonthsDescription:ONSITE ONLY - supporting Cambridge, AMA.Ideal candidate: 3 YOE in field desired with bachelors. Experience working in a regulated industry, exposure to GMPs, Medical Device experience is highly desired. Mathematical background fundamentals of statistics. Useful to have exposure to test method development, CAD design, Solidworks, mechanical modeling. Nice to have programming R and python experience. hands on technical experience useful, comfortable working within a lab.Job Details: Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for the Combination Product Operations MS&T - Physical Sciences and Engineering (PSE) organization. Responsibilities include development and lifecycle management of Physical GMP Test Methods, lifecycle management of integrated testing machines, development and validation of test methods. The successful candidate employs basic engineering skills and practices to gather user requirements and translate them into technical documentation. Assist with project definition by performing engineering studies and assessment for automated test systems installations. Perform field evaluations of existing systems and provide engineering design recommendations.The ideal candidate enjoys tackling challenges and excels at organizing information from numerous sources to provide well-constructed deliverables. This individual has a passion for modeling, analytics, and technology. The successful candidate will be given opportunities to apply their expertise to enhance the way data is used to inform and make decisionsThis may include, but is not limited to, the following:• Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.• Knowledge on Equipment and Method validation principles, generation of Lifecycle Documentation such as FAT/SAT, IQ/OQ, equipment characterization protocols, Gauge Repeatability and Reproducibility studies• Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.• Developing, enhancing, automating, and managing test data• Network with manufacturing and quality organizations internal to Amgen• Ensuring all tasks and responsibilities are performed according to industry-leading scientific standards & accurately documented per SOPs• Monitoring technological developments in the field & evaluation of new technologiesPreferred Skills• Experience working in a regulated industry, exposure to GMPs• Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership• Statistical analysis, and knowledge of Gage R&R,• Knowledge of Optical measurement devices, force testers, BLE testing• Test method development, CAD design, Solidworks, mechanical modeling• Manufacturing experience, IQ, OQ, and PQPreferred Traits:• Passion for proactively identifying opportunities through creative data analysis and modeling• Intellectual curiosity with ability to learn new concepts/frameworks, algorithms, and technology rapidly as needs arise• Ability to manage multiple, competing priorities simultaneously, experience with MS ProjectBasic Qualifications Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experienceTop 3 Must Have Skill Sets: • Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership• Ability to manage multiple, competing priorities simultaneously• Statistical analysis, and knowledge of Gage R&R,Day to Day Responsibilities: • Develop and support lifecycle management of physical test methods and associated documentation(test method protocols, SOPs, training documents, etc.)• Execute test method protocols, analyze data• Maintain projects status and communicate with Amgen internal clients

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates® as well as fully synthetic Bicycle® systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high unmet medical need. Bicycle is headquartered in Cambridge, UK, and our US operations run out of Cambridge, MA.Culture is key and all Bicycle employees actively embrace and role model our company values:WeareAdventurous.We believe it'sthewaytodeliverextraordinaryresultsforourpatients.WeareDedicatedtoourMission.Youcan'tchangetheworldifyoudon'thavedetermination.WeareOneTeam.Weonlysucceedwhenweworktogether.Job DescriptionSenior Manager, Quality provides Quality oversight for Bicycle's development programs, ensuring compliance with applicable ICH GCP and GLP standards and global regulations. As an integral member of the team tasked with product development, the position serves as a Quality and compliance business partner, engaging with multiple collaborators. The ideal candidate must be comfortable working independently, managing interactions with and between team members, both internally and externally. The position will be a member of the Development Quality group, reporting to the Head of Development Quality.Collaborate with global program teams to ensure protocol, procedural, GCP / regulatory compliance and inspection readiness throughout all stages of product developmentDevelop and maintain quality dashboards/ metricsAnticipate, identify, communicate, and manage quality issues to resolution, including escalation to key stakeholders across the business.Contribute during internal cross-functional meetings to review and document oversight of company Quality initiatives.Support applicable change management pertaining to new and/or evolving global regulations, and anticipate any changes that may impact the development strategies for programsSupport the review of key clinical trial documents (INDs, manuals, study plans, etc.) for compliance with existing policies and procedures, ICH GCP and applicable global regulatory requirementsParticipate in the planning, conduct, management, review, documentation, communication and follow up of internal and external quality audits, vendor qualification and assessmentsContribute to the development and delivery of Quality training modules for internal company employees enabling a culture of quality throughout companySupport preparation for, and coordination and management of regulatory agency inspections, including sponsor/monitor inspections and clinical investigator site inspectionsSupport vendor selection/qualification activities (including but not limited to vendor audits and maintenance of preferred vendor list)Provide expert quality consultation to stakeholders (e.g., Clinical Operations, Data Management, Pharmacovigilance, etc.) based on analysis and interpretation of applicable regulations. Identify and partner with key collaborator functions and business partners as appropriate.Assist development team business partners with development and documentation of CAPAs and effectiveness checks, as applicable.Support the development and maintenance of company Quality Management System (QMS) and integrated Learning Management System (LMS) and Controlled Document System as appropriate.QualificationsThe position requires a Batcheler's degree in a science or healthcare fieldDemonstrable experience in Quality Assurance within the life sciences industry, ideally covering all clinical phases, with demonstrable experience in a GCP quality/compliance roleKnowledge of GCP, FDA, MHRA and EMA regulatory requirements for clinical trial submissions (USA, UK & EU), understanding of 21CFR Pt. 11 with respect to clinical systems (QMS)Knowledge of GLP /GCLP preferredStrong familiarity with eTMF requirementsExperience conducting audits, reviewing audit reports and following up on CAPAsExperience leading quality event investigations/ root cause analysisA thorough understanding of global drug development functional areas including preclinical, clinical, regulatory affairs and manufacturingHighly collaborative, strong relationship building skills with high level of integrity.Adaptable and strategic thinker with the ability to generate creative solutions to complex problems, identifying different and novel ways to find solutionsDemonstrated ability to work proactively using solid communication and influencing skills to effectively execute program goalsExhibits flexibility and is a self-starter with a strong attention to detailDemonstrated ability to adapt working style to those of others for effective communication; able to multi-task and support multiple teams with varying levels of complexityAble to work effectively in highly complex and fast-paced environmentsStrong organizational and time management skillsFamiliarity with Electronic Document Management (EDM) systems and Microsoft Office suitePosition requires both domestic and international travel up to 10% of timeAdditional InformationFlexible working environmentCompetitive reward including annual company bonusMedical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the CompanyHealth and Dependent Care Flexible Spending Accounts401(k) plan with a 4% Company match and immediate vestingEligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional daysEmployee assistance programEmployee recognition schemes10 Company holidaysCompetitive Family Leave PolicyEligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.All your information will be kept confidential according to EEO guidelines.Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.

Quality Development Engineer As a Quality Development Engineer, you will contribute to developing high quality, robust InterSystems IRIS Data Platforms software by working hard to uncover weaknesses and areas for improvement. If you are passionate about software you will excel in this role by building tools and automation that verify new technologies and new healthcare-related protocols as well as verifying that these new technologies do not adversely affect existing products. Successfully, we will use your strong technical capabilities, curiosity to learn new things, creativity, and resourcefulness as an essential part of InterSystems' innovation process. Duties and Responsibilities: Develop test scenarios, author and execute test plans.  Specialize in high availability and performance Review product source code to inform test design for edge and stress test case development for key areas of the product such as failover and recovery Write software to test product functionality in a heterogeneous multi-platform environment with a focus on destructive testing Collaborate with interdepartmental teams to provide early feedback on new features Promote product quality by advocating for the customer's point of view Communicate about defects for assignments that range from verification of targeted changes to optimizations for new hardware, and where specifications range from informal concepts to detailed descriptions As the customer's representative, verify that the product meets the customer's needs Review the documentation and verify that it is clear and concise. Ensure that the documented procedures are clear and easy to follow. Develop automated functional, load and stress tests for InterSystems HealthShare Qualifications: Ability to read code critically, finding bugs, weak spots and performance bottlenecks Enthusiasm for debugging and learning new skills Understanding of Software Development Life Cycles (SDLC) Familiarity with application development, relational databases and object-oriented development, cloud technology Effective communication and analytical skills Curiosity and aptitude for acquiring new technical skills and knowledge in a dynamic and highly technical environment Versatility and flexibility   Desirable: Familiarity with software test tools and automation methodologies Experience with cloud, container and provisioning technology Experience with one or more of the following scripting languages: Perl, Python Object-Oriented programming (Java, DotNet, C#, C/C++, Python) Experience with Windows batch and PowerShell scripts, UNIX sh and bash scripts Experience with coding for or testing low-level multi-threaded applications Experience with distributed systems and networking Technical knowledge of operating systems Familiarity with UI (Angular, Typescript, JS) and UI test automation (Selenium) Familiarity with accessibility tools (SortSite, Deque) Education and Training: BS/MS in Computer Science or equivalent.  About InterSystems Established in 1978, InterSystems provides innovative data solutions for organizations with critical information needs in the healthcare, finance, and logistics sectors and beyond. Our cloud-first data platforms solve interoperability, speed, and scalability problems for organizations around the globe. InterSystems also develops and supports data management in hospitals through the world's most proven electronic medical record, as well as unified care records for health systems and governments through a powerful suite of healthcare data integration solutions. The company is committed to excellence through its award-winning, 24×7 support for customers and partners in more than 80 countries. Privately held and headquartered in Cambridge, Massachusetts, InterSystems has 25 offices worldwide. For more information, please visit InterSystems.com .

Job DescriptionThis role is located in Cambridge, MA or RTP, NC.The Head of Product Development and RegCMC, Biologics and Advanced Therapy Medicinal Products leadership role in PO&T is responsible for the process, analytical, and technology development of all biologic and advanced therapy medicinal product (ATMP) modalities including existing protein-based drugs, monoclonal antibodies, and gene therapy assets. The role has end-to-end CMC product responsibilities from pre-clinical to commercial life cycle process development activities, process platform strategies, and regulatory CMC management/filings across the biologics/ATMP modality portfolio. This role is ultimately accountable for delivering GMP-ready processes to manufacturing, phase-appropriate process optimization (i.e., COGS optimization), and regulatory CMC filing/approvability across all global healthcare regions. In addition to process and analytical development, the position oversees multi-disciplinary international teams supporting Quality oversight, CMO/CRO execution and strategy, regulatory filings, and manufacturing technology transfer. The leader guides, coaches, and develops team members to lead, collaborate, and engage in a matrix set of responsibilities with Biogen; this includes direct line reports as well as the facilitations of dotted line responsibilities of staff, and considerable partnership/alignment with Asset Development Program Management (ADPM) group.This role sits on the PO&T leadership team, is the primary decision maker as a member of the PO&T Governance Committee (GC) for this modality, and has extensive interface and influence with critical stakeholders including Discovery & Research, Translational Sciences, and Clinical Development, external partners/collaborators representing PO&T on partner joint steering committees and various industry influencing forums.Principle Accountabilities Include: 1. Sets the strategic direction and priorities to ensure development, delivery, life cycle, and regulatory management of programs/products in modality area of responsibility. Provides leadership, oversight, and direction to the cross-functional team responsible for the work.2. Works cross-functionally to drive CMC strategy for products in modality area of responsibility. Identifies and resolves barriers associated with meeting CMC portfolio deliverables to ensure timelines are met. Develop CMC metrics/analytics to support decisions and development timelines. Represents PO&T in external due diligence and partnership evaluations3. Contributes expertise to PO&T GC across the portfolio, particularly in assigned modality area. Establishes expert teams to support PO&T program or product strategy. 4. Leverages best CMC practices in the industry through professional forums and other external outreach; applies novel and forward-thinking ideas to influence Agencies. 5. Inspires others, develops and engages staff to leverage abilities, and builds a sense of belonging for the team. Manages synergy with line functions with regards to business/plan objectives, resources, and budget allocation in partnership with G&A. QualificationsWho You AreYou are able to balance deep technical expertise with strategic product planning and insights. You demonstrate exceptional leadership abilities including organizational awareness, business acumen, political astuteness, influencing/negotiations, decision making ability, conflict resolution, and demonstrated ability to influence and inspire teams. You have a proven track record of success in managing complex development portfolios and project plans and developing internal talent as well as demonstrated success in alliance and partner management.Education: MS, PhD preferred in pharmaceutical related field.Experience and Skills: Minimum of 15+ years of relevant experience in the pharmaceutical industry, including product development and/or commercialization experience. Must have demonstrated experience in leading/engaging others in a direct and highly matrixed and fast growing and global health care organization, and broad technical knowledge across multiple modalities.Additional InformationWhy Biogen?We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. PDN-9bd977f2-c7fb-44ea-9a4b-a3c3815e2b48

Harvard UniversityTitle: Postdoctoral Fellow in the Mechanics of Advanced Mechanical and Electronic Structures School: Harvard John A. Paulson School of Engineering and Applied Sciences Department_Area: Materials and Mechanical Engineering Position Description: We are seeking a full-time postdoctoral researcher in mechanics, mechanical engineering, or materials science to join the research group of Professor Joost Vlassak at the Paulson School of Engineering and Applied Sciences at Harvard University. The project focuses on the design and microfabrication of structures to carry payloads in the mesosphere using photophoretic levitation. In addition, the successful candidate will be expected to contribute to a project on the reliability of complex integrated circuits and assemblies, including state-of-the-art 3DICs, and on how to prevent mechanical failure during fabrication or use of these systems. The work is done in close collaboration with a leading semiconductor manufacturer, and will require both experiments and computational modeling. Candidates should have a strong interest in contributing to multidisciplinary teams (mechanical engineers, electrical engineers, materials scientists, and R&D engineers in industry) and are expected to publish scholarly papers in archival journals. They are also expected to take on a mentorship role for graduate students. The position is available beginning in June 2024. The initial appointment will be for one year with a possibility for renewal of a second year depending on performance and availability of funds. Further information about the research lab is available at https://vlassakgroup.seas.harvard.edu/home Basic Qualifications: Ph.D. in mechanics, mechanical engineering, materials science, or a closely related field. Additional Qualifications: Experience with experimental mechanics as well as finite elements; strong publication record in top journals; excellent written communication skills; and strong interpersonal and collaborative skills. Special Instructions: CV, cover letter describing research interests and goals, a full list of publications, copies of up to three relevant scientific papers, as well as the names and contact information of three references who are able to provide letters of recommendation. Contact Information: Professor Joost Vlassak308 Pierce Hall29 Oxford StCambridge MA 02138 Contact Email: [email protected] Equal Opportunity Employer: We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation, pregnancy and pregnancy-related conditions or any other characteristic protected by law. Minimum Number of References Required: 3 Maximum Number of References Allowed: 3 Supplemental Questions: Required fields are indicated with an asterisk (*).PI239890670

Harvard UniversityPosition Title: Maintenance OperatorReq ID: 65596BRSchool or Unit: Campus ServicesDescription: Job SummaryEnergy & Facilities (E&F) operates and manages Harvard's energy supplies, district energy plants, and utility infrastructures on the Cambridge/Allston campuses, as well as 24/7 facilities -related call, alarm monitoring and dispatch center. E&F provides a broad portfolio of labor-based services, including building maintenance, landscaping and custodial to a large portion of the University, as well as engineering, technical, and sustainability services. Facilities Maintenance Operations (FMO) a department within E&F, offers primary building maintenance, landscape, fire safety, custodial and event support services to Harvard schools and departments on a fee-for-service basis. All services are provided in strict accordance with regulatory requirements and customer-determined standards.Position DescriptionDuties and Responsibilities: Provides initial response, triage, stabilization and/or repair for all types of building infrastructure maintenance requests, with emphasis on HVAC systems. Inspects, adjusts, modifies, and repairs all types of boilers, heating systems, cooling systems and auxiliary equipment. Interprets mechanical plans and prints and updates as necessary. Monitors, queries and reports on the status of building systems managed by DDC technology. Initiates follow-up actions as required. Provides responsive customer support in all phases of building maintenance and operations. Assists and advises customers on maintenance solutions and provides follow-up on progress and status of work. Performs other core skills of the trades and related duties as required. May be assigned to work independently or as part of a multi-trade team under the guidance and direction of the Area Supervisor and/or Working Foreperson. Basic QualificationsBasic Qualifications: Five years related experience in the maintenance and operation of complex building system infrastructure. Must possess a current State HVAC license (or equivalent). Must possess a valid driver's license.Additional Qualifications and SkillsAdditional Qualifications: Must be knowledgeable and experienced in the installation, operation, trouble-shooting, maintenance and repair of all types of commercial building heating and cooling systems. Must observe and comply with all standard safety codes and practices, perform work in accordance with recognized trade and University standards. Must be able to read and interpret detailed plans, specifications, operating manuals and other written materials associated with this trade. Must be able to effectively communicate with peers and customers.Technology Skills Required: Basic proficiency and understanding of Windows based software applications. Demonstrated proficiency with electronic mail, MS Office, and related desktop and handheld devices and applications required. Familiarity with smartphone technology and willingness to expand skills with handheld device use as required.Special Requirements: Must supply a complete set of hand tools. Required to wear/use appropriate safety clothing/equipment at all times. Required to wear to properly wear a uniform and maintain a professional image at all times.Working Conditions Must possess a current State HVAC license (or equivalent). Must possess a valid driver's license.Additional InformationEmergency Status Designation: Critical Operations Personnel (required to provide on-site support during emergency situations as determined by management).The health of our workforce is a priority for Harvard University. With that in mind, we strongly encourage all employees to be up-to-date on CDC-recommended vaccines.BenefitsWe invite you to visit Harvard's Total Rewards website (https://hr.harvard.edu/totalrewards) to learn more about our outstanding benefits package, which may include:Paid Time OffHealth and Welfare.Work/Life and WellnessRetirementTuition Assistance ProgramTuition ReimbursementProfessional DevelopmentCommuting and TransportationHarvard Facilities Access, Discounts and PerksDepartment Office Location: USA - MA - CambridgeJob Code: 269000 Maintenance OperatorJob Function: FacilitiesWork Format: On-SiteSub Unit: Energy & FacilitiesSalary Grade: 000Department: Facilities Maintenance OperationsUnion: 42 - Int Un Oper Engineers Loc 877Time Status: Full-timePre-Employment Screening: Criminal, DMV, Drug Testing, Employment, Identity, License/Cert.Schedule: Sunday: 3:00pm - 11:00pm Monday: 3:00pm - 11:00pm Thursday: 11:00pm (Wed) - 7:00am (Thu) Friday: 11:00pm (Thu) - 7:00am (Fri) Saturday: 7:00am - 3:00pmCommitment to Equity Diversity Inclusion and Belonging: Harvard University views equity, diversity, inclusion, and belonging as the pathway to achieving inclusive excellence and fostering a campus culture where everyone can thrive. We strive to create a community that draws upon the widest possible pool of talent to unify excellence and diversity while fully embracing individuals from varied backgrounds, cultures, races, identities, life experiences, perspectives, beliefs, and values.EOE Statement: We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation, pregnancy and pregnancy-related conditions, or any other characteristic protected by law.PI239911671