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