Manufacturing Engineer Salary in New Haven, CT

This is what you will do:The position will oversee and lead technical transfer of early and late clinical phase drug substance, to both internal and external contract development & manufacturing (CDMO) companies. This position is responsible for providing strong scientific leadership, mentorship for junior team members and subject matter expertise for all aspects of drug substance including technology transfer, process fit analysis, process modelling, raw material controls and aspectic process assurance/microbiological control. The Principal Engineer will also lead timely risk identification, communication and resolution and work in close collaboration with Process Development and Clinical Supply (PDCS), non-GMP internal Pilot network, Alexion Operations, Quality (QA), Regulatory (RA), Analytical Development Quality Control (ADQC) and internal and external Manufacturing sites. Other areas of responsibility include technical support for ongoing clinical manufacturing, process troubleshooting to manufacturing activities such as supporting process related investigations, deviation resolution, corrective actions/preventative actions, and direct responsibility for process monitoring/control charting of manufacturing operations. Review of technical documents and support for regulatory submissions (IND/IMPD, BLA/MAA) are other responsibilities. The successful candidate must have mature team-working behaviors and organizational awareness and insight.You will be responsible for: Manage and lead clinical technical transfer process and ensure alignment with CMC schedule to meet program and corporate goals / metrics, as required. This includes continuous communication with Quality Assurance, Quality Control, Upstream and Downstream Process Development, Drug Product Development, Analytical Sciences and Supply Chain teams to ensure efficient tech transfer of Alexion's clinical drug substance manufacturing activities.Provide technical leadership and oversight for internal and external technology transfersLead technical evaluation and contribute to selection of external manufacturing facilities for drug substancePerform facility fit analysis, process gap assessments, and establish operational control strategy for each new receiving siteLead efforts to assess readiness for early and/or late phase transfers using appropriate tools and manage risk communication with leadership along with proposed mitigation/sLead creation and/or technical review of batch records, process validation protocols, change controls, and deviations to support GMP manufacturing throughout lifecycle of biologics pipeline in partnering with QA and Alexion operations as applicableEnsure appropriate data management, perform process monitoring and communicate operation status to management. Provide technical depth and lead OOT and deviation investigations as requiredServe as Drug Substance Team Lead, including representation at CMC asset team, to support late-stage pipeline programs through validation campaigns and initial commercialization, as requiredEnsure appropriate escalation of issues and risks and lead cross functional team to identify and drive alignment on action/mitigation plan for path forwardLead continuous improvement of efficiency of technology transfer plans and work process and influence manufacturing sites to focus on improving efficiency of technology transfer processesEnsures effective collaboration of all involved functions and external partiesManage and develop matrix team providing opportunities and actively supporting career enhancement and growthCo-author and review IND/IMPD, BLA/MAA and other technical documents for regulatory agency submissionsGlobal role requiring domestic and international travel (~20%)You will need to have:PhD in biochemistry, biological science, or chemical engineering or related fields with 6+ years of relevant experience, or BS/MS with 10+years of relevant experience in biopharmaceutical organization with expertise in drug substance development and/or tech transferPassport and ability to travel domestically and internationally for manufacturing site supportThis role is primarily office based. During travel for manufacturing support, this role requires physical capabilities to gown and don PPE in GMP cleanroom environment and be present during manufacturing operations in a technical support role. Physical elements include standing, climbing stairs, ladders, visual capability to read manufacturing control screens, use a computer, engage in communications via phone, video, and electronic messaging. Intellectual capabilities include engaging in problem solving and non-linear thought, analysis, and dialogue, collaboration with other peer functional representatives.Requires technical services experience for discrepancy resolution, CAPA implementation and process data monitoring for internal and external facilitiesExperience with upstream or downstream manufacturing of monoclonal antibodies/therapeutic proteins with lab and pilot plant operations (non-GMP/GMP)Requires strong understanding of technology transfer, process fit analysis and clinical phase appropriate process oversight and control, with expertise in late phase technology transfer and validationComprehensive understanding of cGMP/ICH requirements for clinical and commercial biopharmaceuticalsAbility to present and defend technical aspects of manufacturing operations during regulatory agency inspectionsAbility to influence others without direct authority, including external partners, and communicate with all levels of the organizationStrong project leadership and resource management skills along with good verbal and communication skillsAbility to support development of aggressive but achievable project plans to ensure effective, timely executionWe would prefer for you to have:Knowledge in planning for program advancement to process validation and commercial launch, with experience supporting teams through BLA approvalsStrong knowledge and experience in downstream bioprocess development, scale-up, technology transfer, and process characterization.Expertise in CFD modelingExpertise in raw material or microbiological control strategyCapability to analyze data using basic statistical methods, and present comparability analysis in evidence of effective transferKnowledge of quality attribute measurement assays and application to troubleshooting product quality related descrepancies.Structured problem solving experienceAstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

This is what you will do:Alexion's Product Development and Clinical Supply (PDCS) organization is seeking an automation engineer to enable design and deployment of advanced laboratory and process automation systems for the Synthetic Process Development team, with emphasis on ensuring seamless data flow to enable modeling, AI/ML, data visualization, and data-rich experimental records. The Senior Automation Engineer, Synthetic Process Development, will leverage deep data engineering and laboratory automation expertise and will focus on the architecture, design, control, and data management of robotics and automated systems that will drive efficiency, inform data-driven decisions, and enable the design and development of pharmaceutical manufacturing processes. You will collaborate extensively with Alexion scientists and engineers as well as external partners to provide data management and operational solutions for laboratory and process automation.You will be responsible for:Designing, deploying, and sustaining software and data management solutions to enable innovative laboratory automaton systems, as well as highly flexible and reconfigurable automated miniaturized manufacturing systems.Leveraging expertise in multiple programming languages, database management systems, and cloud technology to enable advanced laboratory and process automation for pharmaceutical research and development.Acting as the Synthetic Process Developoment team's main point of contact with Alexion / AstraZeneca IT partners, and clearly translating scientific business requirements into actionable IT and data management strategies.Driving innovation and leading collaborations with strategic partners.Acting as a thought leader in data engineering, robotics, and automated process control, with demonstrated mastery of multiple automation platforms and ability to rapidly gain proficiency in additional platforms.Building a comprehensive understanding of scientific workflows and key data flows within the Synthetic Process Development team, and applying this understanding to create a strategic vision for the development of future laboratory and process automation systems, and associated innovations in data management strategies.Keeping up-to-date with the latest advancements through publications, participation in precompetitive consortia, via knowledge exchange with strategic business partners, and where possible, via conference attendance.You will need to have:Degree in software engineering, computer science, or related scientific field (chemical engineering, robotics, etc.) with relevant hands on experience in data engineering, robotics, and laboratory automation (PhD or Postdoc: 0-5 years experience, MS: 5+ years experience, BSc: 10+ years experience).Expertise in multiple programming languages (Python, C#, etc.), database management (SQL, NoSQL, etc.), and cloud technology (AWS, serverless design pattern, etc.).Expertise in creating, modifying and troubleshooting scripts for laboratory robotics and process automation, and managing seamless data flow.Demonstrated ability to work independently in a fast-paced team-centered environment, and rapidly learn new skills.Excellent verbal and written communication skills.Experience in design and deployment of integrated automated platforms incorporating components from multiple vendors, with emphasis on integrated data management strategies.Ability to plan and execute complex technical projects, and remotely manage timelines for development activities at external strategic business partners.Up to 15% travel, with ability to work independently from remote locations.The duties of this role may require periodic work in a laboratory or manufacturing environment. As is typical of such roles, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:Experience in automated chemical synthesis, analysis, and purification.Understanding of the overall drug development and commercialization process, from discovery through product launch and lifecycle management.Prior experience in chemometrics, including use of multivariate data analysis, in situ reaction monitoring, reaction profiling, and development of first-principles process chemistry models.Working knowledge of flow chemistry and continuous processing.In-person statement for 4 days in the office:When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

The EHS Coordinator & Quality Engineer will be responsible for the following:Support all QHSE functions which are applicable according to the requirements of the site's integrated management system (IMS) and those of ISO 9001, 14001, and 45001.Develop, implement, and maintain company policies and procedures related to quality, health, safety, and environmental management.Conduct risk assessments and hazard analyses to identify potential threats to employee safety, product quality, and environmental sustainability.Coordinate employee training programs to ensure compliance with safety protocols, quality standards, and environmental regulations.Lead incident investigations and root cause analyses to identify underlying factors contributing to accidents, near misses, or quality issues.Implement corrective and preventive actions to address identified deficiencies and prevent recurrence of incidents.Conduct regular audits and inspections of manufacturing facilities to assess compliance with QHSE standards and regulations.Monitor and analyze key performance indicators (KPIs) related to quality, health, safety, and environmental performance, and recommend improvements as needed.Collaborate with cross-functional teams to promote a culture of safety, quality, and environmental stewardship throughout the organization.Serve as the primary point of contact for regulatory agencies, ensuring compliance with all applicable laws, regulations, and permits.Prepare reports and presentations to communicate QHSE performance, initiatives, and recommendations to senior management and stakeholders.MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.The ideal EHS Coordinator & Quality Engineer will have the following qualifications:Bachelor of Science in Occupational Health & Safety, Environmental Science, Engineering, or a related fieldMasters degree a plus but not required ISO 14001 experience is required Strong communication skills 2+ years of manufacturing experience required and experience with ISO 9001 is a plus

This is what you will do: This position will lead research, design and implement scientific studies to enable the drug product (DP) process development, characterization, clinical manufacturing, and commercial validation of parenteral/injectable biologic products. Lead and support execution of stability studies, data processing, compiling and presentation of results supporting late-stage clinical activities as well as preparation for PPQ. Develop a variety of manufacturing unit operations including, drug substance (DS) freeze/thaw, compounding/mixing, sterile filtration, drug product filling of vials/syringes, visual inspection, and DS/DP transportation. A general understanding of protein chemistry and/or the ability to run biopharmaceutical assays in a laboratory is preferred.The role will lead manufacturing technology transfer activities in preparation for DS and DP PPQs, sending/receiving site process gap analysis, process FMEAs (failure mode and effects analysis), change control owner/leader, master batch record review, as well as leading at-scale/full scale process development studies, and authoring protocols, and reports. In addition, will support deviation investigations, change controls, and CAPAs using electronic Quality system. The candidate will also provide clinical and commercial manufacturing site support including but not limited to periodic meetings, action item owner, and in-person on-site manufacturing support. Interact regularly with multi-functional staff from Analytical Sciences & Quality Control, Drug Substance Process Development, Manufacturing Technical Services, Quality Assurance, and/or CMC Regulatory Affairs to support progress of the program and preparation of source documentation supporting BLA.You will be responsible for: Own the design and implement studies for Alexion pharmaceuticals' clinical drug candidates and commercial products, support tech transfer activities for internal manufacturing and contract manufacturing sitesLead progression of projects with multi-functional collaborators, as well as understand the implications of project activities and decisions with minimal directionPrioritizing multiple tasks and projects independently and as part of the teamAuthor SOPs, study protocols and technical reportsParticipate in multi-functional development teams representing Injectable Drug Product DevelopmentMaintain knowledge of current trends in drug product manufacturing processes, manufacturing equipment and single use systems as well as associated global regulatory expectations and scientific principles and theories. Train other peers as assigned in areas of expertiseActively participate in department and team meetings including assuming ownership and delivering on assign action itemsDevelop presentations for meetings with internal and external partnersYou will need to have:Bachelor's degree in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, or relevant Engineering/Life Sciences field with 4+ years of relevant experience or Master's degree with 3+ years of relevant work experienceDedicated initiative to find resolution for technical challengesExcellent interpersonal, collaborative and communication skillsThe duties of this role are conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video and electronic messaging; engage in problem solving and non-linear thought, analysis and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:Scientific and practical knowledge of protein biochemistry and/or drug product process developmentPrevious experience in bio-therapeutics development as well as relevant knowledge of cGMP and Quality expectations for PPQs and BLAScientific understanding of protein stability, thermodynamics, mechanism of protein degradation, bio-therapeutics drug formulation development and analytical tools used to test formulations is a plusHigh level proficiency in MS Office software including Word, Excel, Outlook, Visio, and PowerPointExpectation of working in the office 4 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world!AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

This is what you will do: This position will lead research, design and implement scientific studies to enable the drug product (DP) process development, characterization, clinical manufacturing, and commercial validation of parenteral/injectable biologic products. Lead and support execution of stability studies, data processing, compiling and presentation of results supporting late-stage clinical activities as well as preparation for PPQ. Develop a variety of manufacturing unit operations including, drug substance (DS) freeze/thaw, compounding/mixing, sterile filtration, drug product filling of vials/syringes, visual inspection, and DS/DP transportation. A general understanding of protein chemistry and/or the ability to run biopharmaceutical assays in a laboratory is preferred.The role will lead manufacturing technology transfer activities in preparation for DS and DP PPQs, sending/receiving site process gap analysis, process FMEAs (failure mode and effects analysis), change control owner/leader, master batch record review, as well as leading at-scale/full scale process development studies, and authoring protocols, and reports. In addition, will support deviation investigations, change controls, and CAPAs using electronic Quality system. The candidate will also provide clinical and commercial manufacturing site support including but not limited to periodic meetings, action item owner, and in-person on-site manufacturing support. Interact regularly with multi-functional staff from Analytical Sciences & Quality Control, Drug Substance Process Development, Manufacturing Technical Services, Quality Assurance, and/or CMC Regulatory Affairs to support progress of the program and preparation of source documentation supporting BLA.You will be responsible for: Own the design and implement studies for Alexion pharmaceuticals' clinical drug candidates and commercial products, support tech transfer activities for internal manufacturing and contract manufacturing sitesLead progression of projects with multi-functional collaborators, as well as understand the implications of project activities and decisions with minimal directionPrioritizing multiple tasks and projects independently and as part of the teamAuthor SOPs, study protocols and technical reportsParticipate in multi-functional development teams representing Injectable Drug Product DevelopmentMaintain knowledge of current trends in drug product manufacturing processes, manufacturing equipment and single use systems as well as associated global regulatory expectations and scientific principles and theories. Train other peers as assigned in areas of expertiseActively participate in department and team meetings including assuming ownership and delivering on assign action itemsDevelop presentations for meetings with internal and external partnersYou will need to have:Bachelor's degree in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, or relevant Engineering/Life Sciences field with 4+ years of relevant experience or Master's degree with 3+ years of relevant work experienceDedicated initiative to find resolution for technical challengesExcellent interpersonal, collaborative and communication skillsThe duties of this role are conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video and electronic messaging; engage in problem solving and non-linear thought, analysis and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:Scientific and practical knowledge of protein biochemistry and/or drug product process developmentPrevious experience in bio-therapeutics development as well as relevant knowledge of cGMP and Quality expectations for PPQs and BLAScientific understanding of protein stability, thermodynamics, mechanism of protein degradation, bio-therapeutics drug formulation development and analytical tools used to test formulations is a plusHigh level proficiency in MS Office software including Word, Excel, Outlook, Visio, and PowerPointExpectation of working in the office 4 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world!Date Posted26-Apr-2024Closing Date30-Jul-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact [email protected]. Alexion participates in E-Verify.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

What Timken makes possible begins with you. Those who came before us helped land a man on the moon, create the world's infrastructure, and introduce renewable energy alternatives. Now you can join the Timken team to write your own unique story and help drive what's next.A career at Timken means you can have an immediate impact doing Work That Matters to the world- improving the efficiency of today's industrial equipment and preparing for the future of motion on our planet and beyond. New employees can start contributing right away, and there are many opportunities to advance your career at your own pace. Join our global team of 20,000 people in 46 countries, and start helping our customers push the limits of what's possible in their world of motion.Timken Power Systems, Schulz Electric brand, is seekingaMechanicfor the New Haven, CT service center responsiblefor performing general labor, mechanical, and maintenance tasks. Essential Responsibilities: Mechanical Assembleris responsible for the assembly, testing, disassembly andinspection and painting of electric motors Various assembly duties while following customer specifications Ensure the quality of all work sent to the test panel Complete all related paperwork accurately and thoroughly Demonstrate the ability to understand and utilize drawings, sketches and geometric dimensioning, tolerances and repair manuals Providing feedback to engineering on assembly/ test discrepancies, drawing errors, quality errors, etc. in an effort to resolve problems and prevent reoccurrences Ability to work overtime, weekends and holidays when necessary to meet production demands is required Basic Qualifications: Associate must be proficient in multiple craft skills needed to repair and manufacture electrical,mechanical and rotating equipment Proficient use of calipers, micrometers, and dial indicators to measure tolerances as tight as .0005 Must be proficient in the care and handling, installation, adjustment, lubrication and maintenance of anti-friction bearings. Applicant must have both verbal and written communication skills Must have the ability to carry out instructions furnished in written, oral or diagram form Must have mathematical skills with the ability to add, subtract, multiply and divide all units of measure, using whole numbers, common fractions and decimals, along with ability to compute rate, ratio and percent Must be able to effectively present information in one-on-one and small group situations to other employees of the organization Must have a high school diploma or equivalent and 5 years of experience Associate will demonstrate an understanding of and the ability to perform dynamic balancing of rotors and rotating elements All qualified applicants shall be treated equally according to their individual qualifications, abilities, experiences and other employment standards. There will be no discrimination due to gender or gender identity, race, religion, color, national origin, ancestry, age, disability, sexual orientation, veteran/military status or any other basis protected by applicable law. The Timken Company designs a growing portfolio of engineered bearings and industrial motion products that improve the reliability and efficiency of global machinery and equipment to move the world forward. Timken posted $4.5 billion in sales in 2022 and employs more than 20,000 people globally, operating from 46 countries. Why Choose Timken? Over a century of knowledge and innovation A culture of top performance A global, diverse environment Products that contribute to a sustainable world A conviction to improve communities around us Competitive salary and benefits Not Ready To Apply? Stay connected by joining our network and we'll keep you informed about upcoming events and opportunities that match your interests.Talent Community Nearest Major Market: New Haven Nearest Secondary Market: Hartford Job Segment: Maintenance Mechanic, Mechanic, Inspector, Electrical, Manufacturing, Operations, Quality, Engineering

This is what you will do: This position is responsible for leading research, design and execute scientific studies to enable the drug product (DP) process development, characterization, clinical manufacturing, and commercial validation of parenteral/injectable biologic products. Lead and support execution of stability studies, data processing, compiling and presentation of results supporting late-stage clinical activities as well as preparation for PPQ. The candidate will support the development of a variety of manufacturing unit operations including, but not limited to, drug substance (DS) freeze/thaw, compounding/mixing, sterile filtration, drug product filling of vials/syringes, visual inspection, and DS/DP transportation. A general understanding of protein chemistry and/or the ability to run biopharmaceutical assays in a laboratory is preferred. The role will lead manufacturing technology transfer activities in preparation for DS and DP PPQs, including but not limited to sending/receiving site process gap analysis, process FMEAs (failure mode and effects analysis), change control owner/leader, master batch record review, as well as leading at-scale/full scale process development studies, and authoring protocols, and reports. In addition, the candidate will support deviation investigations, change controls, and CAPAs utilizing electronic Quality system. The candidate will also provide clinical and commercial manufacturing site support including but not limited to periodic meetings, action item owner, and as necessary in-person on-site manufacturing support. This position is expected to interact regularly with cross-functional staff from Analytical Sciences & Quality Control, Drug Substance Process Development, Manufacturing Technical Services, Quality Assurance, and/or CMC Regulatory Affairs to support progress of the program and preparation of source documentation supporting BLA. You will be responsible for: Lead the design and execute studies for Alexion pharmaceuticals' clinical drug candidates and commercial products, support tech transfer activities for internal manufacturing and contract manufacturing sites Lead progression of projects with cross functional stakeholders, as well as understand the cross functional implication of project activities and decisions with minimal supervision Prioritizing multiple assigned tasks and projects independently and as part of the team Contribute to the development of strategic project plans for molecules in clinical development Author SOPs, study protocols and technical reports with minimal supervision Participate in cross-functional development teams representing Injectable Drug Product Development Maintain knowledge of current trends in drug product manufacturing processes, manufacturing equipment and single use systems as well as associated global regulatory expectations and scientific principles and theories. Actively participate in department and team meetings including assuming ownership and delivering on assign action items Develop presentations for meetings with internal and external stakeholders with minimal supervision Mentor and train junior Associate Scientists and Engineers regarding drug product development You will need to have: Bachelor's degree in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, or relevant Engineering/Life Sciences field with 7+ years of relevant experience or Master's degree with 6+ years of relevant work experience Self-driven initiative to find resolution for technical challenges Excellent interpersonal, collaborative and communication skills The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video and electronic messaging; engage in problem solving and non-linear thought, analysis and dialogue; collaborate with others; maintain general availability during standard business hours. We would prefer for you to have: Scientific and practical knowledge of protein biochemistry and/or drug product process development is preferred Previous experience in biotherapeutics development as well as relevant knowledge of cGMP and Quality expectations for PPQs and BLA is preferred Scientific understanding of protein stability, thermodynamics, mechanism of protein degradation, biotherapeutics drug formulation development and analytical tools used to test formulations is a plus High level proficiency in MS Office software including Word, Excel, Outlook, Visio, and PowerPoint In-person statement for 4 days in the office:When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

This is what you will do:The Engineer II will design and implement experiments to develop injectable drug product formulations and process characterization studies, including analyzing samples and authoring technical reports. Work on an impactful dynamic team and routinely collaborate to innovate with other members of Injectable Drug Product Development as well as other groups in Product Development and Clinical Supply!You will be responsible for:Execution of formulation screening and stability studies for injectable drug products including proteins, siRNAs, peptides.Drive supporting analytical methods and analysis for samplesSupporting process development and tech transfer of GMP fill finish processes to internal and external manufacturing organizations.Defining drug product processes, scale up studies, transferring information between development and manufacturing sites, as well as preparation of required tech transfer document.Knowledge of cGMP and quality guidelines is required.Authoring internal technical reports on the implemented studiesAssisting in preparation of external regulatory submissions for the Alexion product candidates.Participate in department meetings and other technical and team building activities.You will need to have:Firsthand experience on developing phase appropriate drug product formulations and fill finish processes.Basic principles of protein chemistry and stability, and biologic therapeutic degradation mechanisms.Proven success working with cross functional partners.Firsthand experience with liquid chromatography methods (e.g., SEC, IEX, HIC) and capillary methods (e.g. iCE, LabChip GXII Touch).Strong knowledge of analytical software (e.g. Empower, JMP).Experience with electronic record keeping software, like ELN.Ability to work in a collaborative setting and adhere to timelines is essential.The duties of this role are conducted in an lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:BS or MS degree in Biochemistry, Chemistry, Chemical Engineering or related field from an accredited university with 1+ years of experience for MS or 2+ years of experience with BS.Excellent interpersonal and collaboration skills!Understanding of the biotechnology products life cycle and factors impacting product stability.Expectation of working in the office 4 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

This is what you will do:The position will lead technical transfer of early and late clinical phase drug substance, to both internal and external contract development & manufacturing (CDMO) companies. This position will provide strong scientific leadership, mentorship and subject matter expertise for all aspects of drug substance including technology transfer, process fit analysis, process modelling, raw material controls and aseptic process assurance/microbiological control. The Principal Engineer will also lead timely risk identification, communication and resolution and work in close collaboration with Process Development and Clinical Supply (PDCS), non-GMP internal Pilot network, Alexion Operations, Quality (QA), Regulatory (RA), Analytical Development Quality Control (ADQC) and internal and external Manufacturing sites.Other areas of responsibility include technical support for ongoing clinical manufacturing, process troubleshooting to manufacturing activities such as supporting process related investigations, deviation resolution, corrective actions/preventative actions, and direct responsibility for process monitoring/control charting of manufacturing operations. Review of technical documents and support for regulatory submissions (IND/IMPD, BLA/MAA) are other responsibilities.You will be responsible for: Manage and lead clinical technical transfer process and ensure alignment with CMC schedule to meet program and company goals / metrics, as required. This includes continuous communication with Quality Assurance, Quality Control, Upstream and Downstream Process Development, Drug Product Development, Analytical Sciences and Supply Chain teams to ensure efficient tech transfer of Alexion's clinical drug substance manufacturing activities.Provide technical leadership and oversight for internal and external technology transfers, and process development, where requiredLead technical evaluation and contribute to selection of external manufacturing facilities for drug substancePerform facility fit analysis, process gap assessments, and establish operational control strategy for each new receiving siteLead efforts to assess readiness for early and/or late phase transfers using appropriate tools and manage risk communication with leadership along with proposed mitigation/sLead creation and/or technical review of batch records, process validation protocols, change controls, and deviations to support GMP manufacturing throughout lifecycle of biologics pipeline in partnering with QA and Alexion operations as applicableEnsure appropriate data management, perform process monitoring and communicate operation status to management. Provide technical depth and lead OOT and deviation investigations as requiredServe as Drug Substance Team Lead, including representation at CMC asset team, to support late-stage pipeline programs through validation campaigns and initial commercialization, as requiredIdentify issues and risks and lead cross functional team to identify and drive alignment on action/mitigation plan for path forwardLead continuous improvement of efficiency of technology transfer plans and work process and influence manufacturing sites to focus on improving efficiency of technology transfer processesFoster collaboration of all cross-function and external partnersManage and develop matrix team providing opportunities and actively supporting career enhancement and growthCo-author and review IND/IMPD, BLA/MAA and other technical documents for regulatory agency submissionsGlobal role requiring domestic and international travel (up to ~20%)You will need to have:PhD in biochemistry, biological science, or chemical engineering or related fields with 6+ years of relevant experience, or BS/MS with 10+years of relevant experience in biopharmaceutical organization with expertise in drug substance development and/or tech transferPassport and ability to travel domestically and internationally for manufacturing site supportDuring travel for manufacturing support, this role requires physical capabilities to gown and don PPE in GMP cleanroom environment and be present during manufacturing operations in a technical support role. Intellectual capabilities include engaging in problem solving and non-linear thought, analysis, and dialogue, collaboration with other peer functional representatives.Technical services experience for discrepancy resolution, CAPA implementation and process data monitoring for internal and external facilitiesUpstream or downstream manufacturing of monoclonal antibodies/therapeutic proteins with lab and pilot plant operations (non-GMP/GMP)Demonstrated Understanding of technology transfer, process fit analysis and clinical phase appropriate process oversight and control, with expertise in late phase technology transfer and validationcGMP/ICH requirements for clinical and commercial biopharmaceuticalsAbility to present and defend technical aspects of manufacturing operations during regulatory agency inspectionsAbility to influence others without authority, including external partners, and communicate with all levels of the organizationStrong project leadership and resource management skills along with good verbal and interpersonal skillsAbility to support development of bold but achievable project plans to ensure effective, timely execution!We would prefer for you to have:Knowledge in planning for program advancement to process validation and commercial launch, with experience supporting teams through BLA approvalsExpertise in CFD modeling, raw material or microbiological control strategyCapability to analyze data using basic statistical methods, and present comparability analysis in evidence of effective transferKnowledge of quality attribute measurement assays and application to troubleshooting product quality related discrepancies.Expectation of working in the office 4 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world!AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Ultimate Staffing is working with a leader in the manufacturing industry located in the East Haven, CT area who is looking to bring on a new Project Engineer to support the Engineering team. This is a full-time onsite role located in East Haven, CT and is a direct placement opportunity.Base salary up to $125,000Project Manager• 10+ years experience with engineering background• 5+ years of management experience• Fundamental electric motor knowledge.• Proficient in MS Office and working knowledge of ERP systems.• Responsibilities include negotiating lead times and managing project schedules.• Liaison between the customer service team, sales team and the engineers.• Competitive salary and benefits plus annual bonus.What's in it for you?* Base salary up to $125K* Annual bonus plan* Solid PTO and Benefits package, medical, dental and vision, 401(k) with match, life insurance and disability * Direct placement role with our clientApply today for immediate consideration!All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.