Quality Lead Salary in New Haven, CT

Lead and manage large-scale commercial construction projects, ensuring they are completed on time, within scope, and on budget.Coordinate with architects, engineers, subcontractors, and clients to ensure seamless communication and project alignment.Oversee project planning, scheduling, budgeting, and resource allocation.Ensure all safety regulations and quality standards are met throughout the project lifecycle.Mentor and develop junior team members, fostering a culture of continuous improvement and excellence.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 candidate will have at least 10 years of experience in project management within the construction industry, with a proven track record of successfully delivering complex commercial projects. Strong leadership skills, exceptional communication abilities, and a deep understanding of construction processes are essential. A degree in construction management, engineering, or a related field is preferred.

It's fun to work at a company where people truly believe in what they are doing!Job Description:The Lead Service Specialist assists the Supervisor or Manager in leading the workflow of the Service Specialists. Will accurately communicate with client staff and Epiq team members regarding commitments, deadlines and challenges. Essential Job ResponsibilitiesAssign production tasks to team membersWork independently on production assignments, often at a satellite copy center without direct supervisionEnsure all projects have been properly completed and quality checkedWork to resolve work issues or complaints such as: lost parcel, damaged package, untimely deliveriesAssist management with training new hires on all processesOther duties may include, mail, distribution services, copy, print, records, facilities, reception, hospitality servicesQualifications & Requirements High School Diploma or GEDMinimum of 2 years work experience, preferably in a mail or production, copy, print or scanning environmentAbility to lead others in a professional mannerStrong written and verbal communication skills with ability to resolve complaintsAbility to multitask with attention to detailWorking knowledge of MS Word, Excel and Outlook Ability to lift or move 40 lbs. or greaterAbility to walk, bend, kneel, stand or sit for an extended period of timeThe Compensation range for this role is 19.59 to 21.51 USD per hour and may be eligible for an annual bonus. Actual compensation within that range will be dependent upon the individual's location, skills, experience and qualifications.If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!It is Epiq’s policy to comply with all applicable equal employment opportunity laws by making all employment decisions without unlawful regard or consideration of any individual’s race, religion, ethnicity, color, sex, sexual orientation, gender identity or expressions, transgender status, sexual and other reproductive health decisions, marital status, age, national origin, genetic information, ancestry, citizenship, physical or mental disability, veteran or family status or any other basis protected by applicable national, federal, state, provincial or local law. Epiq’s policy prohibits unlawful discrimination based on any of these impermissible bases, as well as any bases or grounds protected by applicable law in each jurisdiction. In addition Epiq will take affirmative action for minorities, women, covered veterans and individuals with disabilities. If you need assistance or an accommodation during the application process because of a disability, it is available upon request. Epiq is pleased to provide such assistance and no applicant will be penalized as a result of such a request.  Pursuant to relevant law, where applicable, Epiq will consider for employment qualified applicants with arrest and conviction records.

Lead the planning, scheduling, and execution of the construction project from start to finish.Coordinate with architects, engineers, subcontractors, and other stakeholders to ensure seamless project delivery.Monitor project progress, identify potential risks, and implement effective solutions to mitigate issues.Manage project budgets, track costs, and ensure financial objectives are met.Oversee the procurement of materials and ensure timely delivery to the job site.Conduct regular site inspections to ensure compliance with safety regulations and quality standards.Prepare and maintain detailed project documentation, including schedules, reports, and logs.Communicate regularly with clients to provide updates and ensure satisfaction with project outcomes.Lead and mentor the project team, fostering a collaborative and productive work environment.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.Bachelor's degree in Construction Management, Civil Engineering, or a related field.5+ years of experience in construction project management, preferably in the New Haven area.Strong understanding of construction processes, project management principles, and building codes.Proficiency in project management software (e.g., Procore, Microsoft Project).Excellent leadership, communication, and problem-solving skills.Ability to manage multiple tasks and projects simultaneously.OSHA 30 certification is preferred; additional certifications are a plus.

OFFICE LOCATIONArlington, Virginia, USA#Li-Remote#PDNThe location for this position is flexible within countries where The Nature Conservancy is a registered NGO and has an already established office. This position is not eligible for relocation or immigration assistance. #Open until filled. WHO WE AREThe mission of The Nature Conservancy (TNC) is to conserve the lands and waters upon which all life depends. As a science-based organization, we develop innovative, on-the-ground solutions to the world's toughest environmental challenges so that people and nature can thrive. Our work is guided by our values, which include a commitment to diversity and respect for people, communities, and cultures. From a rewarding mission to career development and flexible schedules, there are many reasons to love life #insideTNC. Want to know more? Check out our TNC Talent playlist on YouTube to hear stories from staff or visit Glassdoor.One of TNC's primary goals is to cultivate an inclusive work environment so that employees around the globe have a sense of belonging and feel that their unique contributions are valued. We know we'll only achieve our mission by hiring and engaging a diverse staff that reflects the communities in which we work. Recognizing that people bring talent and skills that have been developed outside the scope of a job, we take a holistic approach to recruitment that considers life experience in addition to the professional requirements listed in our postings. Please apply - we'd love to hear from you. To quote a popular saying at TNC, "you'll join for the mission, and you'll stay for the people."WHAT WE CAN ACHIEVE TOGETHERJoin us as we tackle the intertwined global biodiversity and climate crises by delivering durable, representative, effectively managed, and inclusive protections through the Project Finance for Permanence (PFP) approach. PFPs enable governments and local communities, in partnership with funders and NGOs, to secure long-term management and financing for networks of conservation areas in the form of a deal with a single closing agreement. Accelerating the deployment and impact of this strategy is an organizational priority to deliver lasting outcomes across our 2030 Conservation Goals for Biodiversity, Climate, and People. The Project Director, Project Finance for Permanence (PFP) supports the development and implementation of a set of PFP projects, such as in the Mongolia PFP and a Great Bear Sea PFP, with matrixed teams over various stages of a project lifecycle that secure durable conservation outcomes.The Project Director will take the lead on the development and implementation of one or several projects at a time within our portfolio of PFP projects. For assigned projects, they lead the overall project ensuring the successful delivery and closing of those projects in close partnership with country and regional programs and partners. They are the owner of the project, and responsible for developing a transaction acceptable to all parties. They play a key role in establishing and leveraging strong external relationships with government ensuring strong buy-in for the project. They are responsible for overseeing the technical aspects of the project, including the quality, strategic guidance, and integration across all components of a PFP - strategy, scope, conservation planning, community development, governance, finance, and government engagement.The Project Director will work collaboratively with complex, cross-functional project teams and key stakeholders - notably TNC country and regional teams, Impact Finance and Markets, Development, External Affairs, and the PFP team to ensure the successful closing of PFP transactions. As the project director, they will critically assess project scope and objectives, ensuring all risks and dependencies are addressed in the project plan, and work with the project manager to assemble the project team to deliver successful project results. The Project Director will obtain go/no-go decisions at all project decision points from relevant decision makers and identify and obtain approval for project deliverables from the appropriate staff or teams. Throughout the project lifecycle, the Project Director will monitor and measure project progress, conduct corrective action as necessary, and communicate project status information to all stakeholders. This position reports to the Global Portfolio Director, Project Finance for Permanence. The location for this position is flexible within countries where The Nature Conservancy is a registered NGO and has an already established office. This position is not eligible for relocation or immigration assistance.WE'RE LOOKING FOR YOUThe Global Project Finance for Permanence team consists of a dedicated globally dispersed group of experts dedicated to our mission. We're looking for an individual with a passion for the mission of The Nature Conservancy - to conserve the lands and waters on which all life depends - and who will enhance our ability to reach our 2030 goals. We are looking for an experienced project director who is comfortable working at both a global and local level on large and complicated processes and projects within a matrixed organization, ideally with familiarity and experience across biological realms and extensive conservation experience.Key responsibilities and scope: In close partnership with the in-country and global teams, advances a clear and maintains an integrated PFP project vision and scope. Be ultimately responsible for the Project's quality and content, ensuring the project results in the desired conservation outcomes. Ensure government commitment to and active participation in the project. Builds strong relationships with internal and external partners. Serves as the primary Global PFP counterpart to the country program and other members the Global Protect Business Unit. Leads several cross-functional and matrixed teams to foster and maintain team cohesion and strong communication channels. Makes independent strategic decisions frequently based on analysis, ambiguous information, experience and judgment. Develop and review interim and final deliverables, support project teams in delivering work products at the required standard and in managing dependencies between projects. Keeps the leadership group informed of progress and updates, identifies obstacles and potential delays, proposes adaptive action and decisions required, ensures effective communication between the leadership group and project teams. Support efficient decision making at key decision points, working with relevant decision makers and the appropriate staff or teams. Assess project progress and risks, conduct corrective action as necessary, and resolve or proactively escalate challenges as needed. Perform issue resolution, negotiate trade-offs, manage conflicts, and collaboratively solve complex problems. They may advise TNC communications, marketing, and philanthropy staff on issues related to priority projects and related issues. Will be required to work across multiple time zones which may include working outside normal working hours. Requires willingness and ability to travel up to 50% both domestically and internationally, and to work occasional weekends and evenings.WHAT YOU'LL BRING BA/BS degree and 7 years' experience in conservation practice or related field or equivalent combination of education and experience. Experience directing a major complex program or project of strategic importance, including management/supervision of multi-disciplinary teams and meeting deadlines. Supervisory experience, including motivating, leading, setting objectives and managing performance. Experience in partnership development with non-profit partners, community groups and government agencies. Able to influence and work productively with these stakeholders. Experience writing and editing promotional and informational material. Experience presenting to and/or communicating with government or legislative staff, community or business leaders, program leadership and/or similar audiences Experience negotiating complex agreements, ideally with governments. Experience with financial management of very large programs and bringing these to a successful close.DESIRED QUALIFICATIONS Master's degree in a relevant discipline and 10 years of experience in conservation practice or equivalent combination of education and experience. Multi-cultural or cross-cultural experience appreciated. Experience working with current trends and practices in relevant discipline(s) (e.g., government relations, biodiversity, climate mitigation, community development). Experience developing business plans or major strategy assessments, particularly with deal structuring, and government negotiations. Experience influencing, developing, and implementing conservation policy and plans with sub national and/or national governments. Experience working in a matrix organizational setting. Experience with innovative conservation finance and/or conservation trust funds. Strong strategic development skills. Strong English language communications skills, including ability to communicating clearly via written, oral, and graphical forms, and ability to communicate effectively with a range of audiences. Fluency in language other than English (e.g. Spanish, Portuguese, French). Knowledge of politics and society with respect to environmental and international affairs. Willingness to learn and develop expertise in new conservation strategies, economic drivers, management tools, and global affairs. Strong team player who can build relationships and work collaboratively across the organization, including with senior management, and with partners.WHAT WE BRINGSince 1951, TNC has been doing work you can believe in. Through grassroots action, we have grown from a small non-profit into one of the most effective and wide-reaching environmental organizations in the world. Thanks to more than 1 million members, over 400 scientists, and the dedicated efforts of our diverse staff and partners, we impact conservation around the world! TNC offers competitive and comprehensive benefits packages tailored to the individual countries where we work. These may include health care benefits, retirement benefits, parental leave, paid time off, life insurance, and disability coverage as well as an employee assistance program and other life and well-being benefits. Learn more about our benefits on our Culture Tab on nature.org/careers. We're proud to offer a flexible work environment that supports the health and well-being of the people we employ.SALARY INFORMATIONThis position may be based in any country where TNC has an established entity, taking into consideration legal restrictions, such as non-national ratios and immigration processing times. For U.S. based applicants only, the starting pay range for this position is generally within the range of $80,000 - $120,000 for annual base salary and is based on location, qualifications, specific skills, and experience. This range only applies to candidates whose country of employment is the USA. For all other applicants, pay ranges will be in local currency, the pay range will be based on the local labor market, and not tied to the above pay range. Your geographic location will be confirmed during the recruitment and used to determine your actual pay range. Additionally, for all applicants, actual pay will fall within a range based on a variety of factors including, for example, the candidate's qualifications, specific skills, and experience. APPLY NOWTo apply for job ID 55566, submit your materials online by using the Apply Now button at https://careers.nature.org/. Need help applying? Visit our recruitment page or contact [email protected] recruiting process is a rolling interview process to ensure we engage applicants in a timely manner. This means we review applications in the order in which they are received. Once a strong candidate pool is identified, the role will be unposted. The timeline may vary depending on the expressed interest in the role, so we highly encourage candidates to apply as soon as possible.The Nature Conservancy is an Equal Opportunity Employer. Our commitment to diversity includes the recognition that our conservation mission is best advanced by the leadership and contributions of people of diverse backgrounds, beliefs and culture. Recruiting and mentoring staff to create an inclusive organization that reflects our global character is a priority and we encourage applicants from all cultures, races, colors, religions, sexes, national or regional origins, ages, disability status, sexual orientation, gender identity, military, protected veteran status or other status protected by law.TNC is committed to offering accommodations for qualified individuals with disabilities and disabled veterans in our job application process. If you need assistance or an accommodation due to a disability, please send a note to [email protected] with Request for Accommodation in the subject line.An attractive salary and benefits package is part of TNC's value proposition to our employees. TNC strives to provide competitive pay and bases salaries on the geographic location of the role committing to being equitable across groups and providing hiring salary ranges when possible.Since we support flexible and remote work for our employees, many positions have a flexible location within countries where we're registered as a Non-government Organization and established as an employer. This may mean we're unable to provide a hiring salary range in the posting for some of our positions. However, candidates invited to be part of our interview process will be provided their location specific range upon request.PDN-9cf0f70d-9f5f-4f0e-bed0-e225f298bbd9

This is what you will do: This of Protein Characterization, which is part of the Analytical Development & Quality Control group which is one functional group of Product Development and Clinical Supply team, leads Alexion's efforts to support new molecule manufacturability assessments and characterization of its biotherapeutics by physical and chemical means. This position will manage and oversee extensive product and impurity characterization and degradation pathway analysis for Alexion's non-clinical, clinical and commercial stage products. This position supports CMC by providing characterization summaries and comparability assessment/evaluation reports. This position leads the support efforts for Alexion's Research, Cell Culture, Purification, Quality Control/Quality Assurance and Manufacturing with techniques available in protein characterizations, comparability, force degratiodation and CQA determination core facility. You will be responsible for: Lead physicochemical characterization efforts for all stages of products Establish phase-appropriate product degradation pathways for Alexion's drug candidates Design and execute product comparability assessment and comparability evaluation in a phase appropriate manner to support process changes Design and execute product force degradation in a phase appropriate manner to support comparability and fulfill regulatory requirement. Perform CQA assessment to ensure the desired product quality and support analytical control strategy Lead product and impurity characterization for Alexion's drug substance and drug product. Alexion's product characterization laboratories are equipped with state-of-art instruments. Provide characterization support to Research groups within Alexion Provide reference standard characterization analysis for commercial or early stage products Maintain appropriate compliance within area of responsibility with regards to current SOPs, instrument qualifications and training. Represent the area functions as required during audits by agencies and internal/external auditors Establish systems within area of responsibility to ensure compliance, good lab practices and work You will need to have: Strong protein characterization skills are required demonstrated expertise in a wide range of protein analysis is required Experience and expertise in complying with CMC requirements in product characterization is required In depth understanding of protein degradation pathways is a must In depth understanding of product comparability assessment and evaluation is required Excellent written and verbal communication skills and demonstrated ability to work effectively in cross functional teams are required. Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others. Extensive experience in drafting and reviewing relevant CMC sections for regulatory filing is required. Experience in corresponding with regulatory authorities is required Ability to represent Alexion Pharmaceutical's interests, objectives and policies in a responsible manner is required Explore and assess new analytical tools and enhance the internal toolbox for protein characterization. Identify and Lead Technical development initiatives to expand the Group's capabilities Act as a champion and represent the ADQC team in project team meetings and participate in data presentations and cross-functional collaborations with the opportunity to serve as mentor of project leads Demonstrated leadership and managerial skills are a must. A minimum of 8 years' management experience in a relevant function is required. A PhD in biochemistry or related disciplines with a minimum of 15 years' work experience in the pharmaceutical/biotechnology industry is required We would prefer for you to have: Compliance experience in characterization laboratories and analytical area is preferred Date Posted05-Sep-2024Closing Date24-Nov-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.

This is what you will do: This of Protein Characterization, which is part of the Analytical Development & Quality Control group which is one functional group of Product Development and Clinical Supply team, leads Alexion's efforts to support new molecule manufacturability assessments and characterization of its biotherapeutics by physical and chemical means. This position will manage and oversee extensive product and impurity characterization and degradation pathway analysis for Alexion's non-clinical, clinical and commercial stage products. This position supports CMC by providing characterization summaries and comparability assessment/evaluation reports. This position leads the support efforts for Alexion's Research, Cell Culture, Purification, Quality Control/Quality Assurance and Manufacturing with techniques available in protein characterizations, comparability, force degratiodation and CQA determination core facility. You will be responsible for: Lead physicochemical characterization efforts for all stages of products Establish phase-appropriate product degradation pathways for Alexion's drug candidates Design and execute product comparability assessment and comparability evaluation in a phase appropriate manner to support process changes Design and execute product force degradation in a phase appropriate manner to support comparability and fulfill regulatory requirement. Perform CQA assessment to ensure the desired product quality and support analytical control strategy Lead product and impurity characterization for Alexion's drug substance and drug product. Alexion's product characterization laboratories are equipped with state-of-art instruments. Provide characterization support to Research groups within Alexion Provide reference standard characterization analysis for commercial or early stage products Maintain appropriate compliance within area of responsibility with regards to current SOPs, instrument qualifications and training. Represent the area functions as required during audits by agencies and internal/external auditors Establish systems within area of responsibility to ensure compliance, good lab practices and work You will need to have: Strong protein characterization skills are required demonstrated expertise in a wide range of protein analysis is required Experience and expertise in complying with CMC requirements in product characterization is required In depth understanding of protein degradation pathways is a must In depth understanding of product comparability assessment and evaluation is required Excellent written and verbal communication skills and demonstrated ability to work effectively in cross functional teams are required. Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others. Extensive experience in drafting and reviewing relevant CMC sections for regulatory filing is required. Experience in corresponding with regulatory authorities is required Ability to represent Alexion Pharmaceutical's interests, objectives and policies in a responsible manner is required Explore and assess new analytical tools and enhance the internal toolbox for protein characterization. Identify and Lead Technical development initiatives to expand the Group's capabilities Act as a champion and represent the ADQC team in project team meetings and participate in data presentations and cross-functional collaborations with the opportunity to serve as mentor of project leads Demonstrated leadership and managerial skills are a must. A minimum of 8 years' management experience in a relevant function is required. A PhD in biochemistry or related disciplines with a minimum of 15 years' work experience in the pharmaceutical/biotechnology industry is required We would prefer for you to have: Compliance experience in characterization laboratories and analytical area is preferred 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.

Join us as an Associate Director, CMC Program Management, a key role within the CMC Program Management group for all early and late stage development assets. This role provides global project & program management support to the CMC Teams within Product Development and Clinical Supply (PDCS). The successful candidate will manage and deliver the integrated program timeline, incorporating deliverables across functions, SMEs and indications. This role will help to drive industry-leading PM best-practices across CMC teams.Drive the development of CMC goals in partnership with the CMC Lead, enabling timely filings and delivery of clinical supply for all phases of development. You will lead the generation, alignment and continual monitoring of an integrated CMC program plan across functional lines involved in the development and delivery of supply. Own program/project level budgeting and resource management. Lead operational project management for CMC alliance or co-development programs, including contributing roles on alliance sub-committees and steering committees.Bachelors' degree in scientific field required8+ years of experience managing and leading multiple complex projects/programs within the biopharmaceutical industry, preferably as a CMC PM or drug development PM.Build a highly collaborative and inclusive environment vital for the cross-functional CMC teams to be effective.Strong track record in driving effective program management skills in cross-functional matrix organizations.Excellent knowledge of program and project management discipline and its application to drug development to deliver time, cost, quality, and risk management to teams.Demonstrated success in creating and managing complex program plans, including experience with global teams, budgetary management, resource planning, and risk management.Demonstrated ability to effectively implement the tools and techniques of the program and project management field.Advanced degree in scientific field, or businessPM experience from candidate selection to thru approvalPM experience with small molecules and/or biologicsExperience with Smartsheet, Power BI and other reporting/metrics capabilitiesKnowledge of clinical and commercial manufacturing and distribution issues that impact project/product strategy and planningWhen we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of 4 - 5 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.Joining Alexion, AstraZeneca, Rare Disease means embracing an opportunity where work isn't ordinary. We are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and closer to each other. Combined with our brave, pioneering spirit - we are truly unique in R&D and healthcare. At Alexion, grow and innovate in a business with rapidly expanding portfolio. Enjoy the vibe, entrepreneurial spirit and autonomy of a leading biotech. You'll join an energizing and kind culture where people build connections to explore new ideas and learn.Are you ready to make an impact? To drive change with integrity, supported by a culture that celebrates diversity, innovation, and the power of connection to patient's lived experiences? If this sounds like a team that you want to be a part of... then we'd love to talk. Apply now!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 of Protein Characterization, which is part of the Analytical Development & Quality Control group which is one functional group of Product Development and Clinical Supply team, leads Alexion's efforts to support new molecule manufacturability assessments and characterization of its biotherapeutics by physical and chemical means. This position will manage and oversee extensive product and impurity characterization and degradation pathway analysis for Alexion's non-clinical, clinical and commercial stage products. This position supports CMC by providing characterization summaries and comparability assessment/evaluation reports. This position leads the support efforts for Alexion's Research, Cell Culture, Purification, Quality Control/Quality Assurance and Manufacturing with techniques available in protein characterizations, comparability, force degratiodation and CQA determination core facility. You will be responsible for: Lead physicochemical characterization efforts for all stages of products Establish phase-appropriate product degradation pathways for Alexion's drug candidates Design and execute product comparability assessment and comparability evaluation in a phase appropriate manner to support process changes Design and execute product force degradation in a phase appropriate manner to support comparability and fulfill regulatory requirement. Perform CQA assessment to ensure the desired product quality and support analytical control strategy Lead product and impurity characterization for Alexion's drug substance and drug product. Alexion's product characterization laboratories are equipped with state-of-art instruments. Provide characterization support to Research groups within Alexion Provide reference standard characterization analysis for commercial or early stage products Maintain appropriate compliance within area of responsibility with regards to current SOPs, instrument qualifications and training. Represent the area functions as required during audits by agencies and internal/external auditors Establish systems within area of responsibility to ensure compliance, good lab practices and work You will need to have: Strong protein characterization skills are required demonstrated expertise in a wide range of protein analysis is required Experience and expertise in complying with CMC requirements in product characterization is required In depth understanding of protein degradation pathways is a must In depth understanding of product comparability assessment and evaluation is required Excellent written and verbal communication skills and demonstrated ability to work effectively in cross functional teams are required. Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others. Extensive experience in drafting and reviewing relevant CMC sections for regulatory filing is required. Experience in corresponding with regulatory authorities is required Ability to represent Alexion Pharmaceutical's interests, objectives and policies in a responsible manner is required Explore and assess new analytical tools and enhance the internal toolbox for protein characterization. Identify and Lead Technical development initiatives to expand the Group's capabilities Act as a champion and represent the ADQC team in project team meetings and participate in data presentations and cross-functional collaborations with the opportunity to serve as mentor of project leads Demonstrated leadership and managerial skills are a must. A minimum of 8 years' management experience in a relevant function is required. A PhD in biochemistry or related disciplines with a minimum of 15 years' work experience in the pharmaceutical/biotechnology industry is required We would prefer for you to have: Compliance experience in characterization laboratories and analytical area is preferred 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!Date Posted10-Sep-2024Closing Date24-Nov-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.