Associate Director, AS&T Lifecycle Management; Chemical Method Expert); Gaithersburg, MD, US, MD

Gaithersburg, US | full time | Job

As the Associate Director AS&T Lifecycle Management, you will be making a meaningful contribution to the ongoing product development and regulatory submission (BLA/MAA) of our Protein-based therapeutic pipeline as part of our Analytical Sciences & Technology (AS&T) department. In this role, you will be the main point of contact for specific methods within your area of expertise. You will ensure that the analytical methods comply with GMP standards and provide accurate, precise, and reliable results.

• Provide technical analytical expertise for analytical activities of the Gaithersburg antibody laboratory, and for late-stage and commercial projects across a global network
• Responsible for the design and performance of method validations and transfers as well as method lifecycle activities (e.g. exchange of critical reagents, method performance and laboratory investigations); potential hands-on work in the laboratory required
• Participate in strategic and technical discussions within projects cross-functionally with CMC team members and external partners
• Evaluation and review of technical and regulatory submission documents in a timely manner for the approval and market launch of development products
• Act as analytical SME by providing expert knowledge for regulatory filings, as well as contributing expertise to questions from health authorities and responses to regulatory submissions

• An advanced university degree in Biology, Chemistry, Pharmacy, Biotechnology, or a related field with 10+ years in a regulated environment in the pharmaceutical industry
• Comprehensive expertise in analytical methods specific for ADCs:
  Drug-to-antibody ratio, Free drug, Residual impurities, Unconjugated antibody, Conjugate variants, Conjugated small molecule impurities, Charge variants; additionally beneficial: HPLC, GC, Mass spectrometry, NMR, and IR techniques for the analysis of Linker-payload intermediate
• Hands-on experience with assay development, design and performance of method validations, as well as data analysis and statistical evaluation
• Strong background in CMC activities for late-stage development and commercial biological products
• In-depth knowledge of ICH guidelines, GMP regulations, and industry best practices
• Proven experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA) and interactions with health authorities
• Experience in working in intercultural, cross-functional, and global teams
• Structured way of working, ability to understand and break down complex challenges and plan associated timelines and interdependencies
• Highly motivated and willingness to work in a fast-paced and fast-evolving environment

• Experience managing method validation and transfer activities across external partners.
• Demonstrated ability to lead and support QC quality events and root cause investigations.

Expected Pay Range: $146,300/year to $234,100/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Sitter stream:
  Virtual Tutoring & Childcare Membership
• Paid Time Off:
  Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance
• and more! More details to be shared.

Located in the Bio Health Capital Region near Washington DC and ranked among the top biopharma hubs in the country, Gaithersburg, Maryland offers a unique and diverse cluster across industry, government, and academia for top talent and…