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Director, Bioanalytical Development

Company: Alexion Pharmaceuticals, Inc.
Location: New Haven
Posted on: August 6, 2022

Job Description:

Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.This is what you will do:The Director of Bioanalytical Development is responsible for the leadership of BA activities and the development of the bioanalytical strategy for the projects they support. The incumbent is responsible for providing a detailed bioanalytical development plan that would be approved by project teams and governance bodies. Strong leadership is expected and essential to create an environment and culture that constantly ensures compliance with internal procedures and processes set up by the BA group and with guidance documents from the FDA, EMA and other regulatory agencies. The incumbent is accountable for interactions with regulatory agencies for specific issues on bioanalytical methods and is accountable for provision of the bioanalytical portions of IND, NDA/BLA/MAA, IB CSRs and other regulated documents and when necessary devising strategies for Regulatory interactions. In addition, the incumbent is also responsible for providing input in the development of bioanalytical protocols, ensuring successful input into the design of assays to support the studies and scientific review and approval of work by CROs and consultants. The incumbent interacts with Alexion departments including Regulatory Affairs, Clinical Operations, Biostatistics, Data Management, Project Management, Toxicology, and Discovery Research for the design and execution of bioanalytical components (PK, PD, immunogenicity, complement biomarkers, etc) of studies. The incumbent participates in various teams including Clinical Pharmacology sub-team, study teams and project teams to support therapeutics at various stages of discovery/development.You will be responsible for: Develop a bioanalytical strategy and a bioanalytical development plan for therapeutics at various stages of development Create a culture and environment of compliance, continual improvement and high productivity Direct a function within Bioanalytical development to develop SOPs that guide the day-to-day operations of the regulated bioanalytical laboratory and to ensure that the bioanalytical staff is fully trained on these SOPs and associated regulations (including GLP)/regulatory guidance documents Accountable for the compliance of all regulated bioanalytical laboratory operations, to support development activities, with good laboratory practices (GLP), OECD regulations, FDA, EMA, PMDA and other relevant global bioanalytical and immunogenicity guidance documents Supervise and manage a bioanalytical (BA) sub-team to support nonclinical and clinical studies by developing and qualifying/validating bioanalytical assays as appropriate Serve as the BA Project Lead for advanced projects in the pipeline requiring input from a highly experience bioanalytical scientist on PK, PD and immunogenicity assays. Lead the interpretation of bioanalytical data provided to project teams and Alexion governance bodies. Responsible for the preparation of BA sections of clinical study protocols, reports and the BA sections of IND, IMPD, BLA/MAA, EOP2 meetings and other regulatory documents.You will need to have: Strong knowledge bioanalytical development for biologicals and experience in managing bioanalytical projects Strong knowledge in GxP regulations that pertain to Bioanalytical Development Experience in writing documents to be included in regulatory submissions for NDA/BLA and meeting with regulators to discuss the bioanalytical package that is included in the final NDA/BLA submission Strong management skill and capability Leadership skill and capability; has people management experience Hands-on experience with developing, validating and troubleshooting pharmacokinetics, pharmacodynamics, and immunogenicity assay development and validations Experience in preparing bioanalytical components of clinical and non-clinical study protocols, study reports Experience in regulatory agency inspection Willingness to potentially travel approximately about -10% of the time The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: 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: Doctoral degree (PhD) in biology, biochemistry or relevant discipline A minimum of 8 years of pharmaceutical industry experience in supporting regulated bioanalysis in non-clinical and clinical studies Experience in managing CROs is desirable LIDI-1Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: .Alexion 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, parental status (including adoption or surrogacy), pregnancy (including childbirth, breastfeeding, or related medical conditions), 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 accommodations@. Alexion participates in E-Verify.As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here.

Keywords: Alexion Pharmaceuticals, Inc., New Haven , Director, Bioanalytical Development, Executive , New Haven, Connecticut

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