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Associate Director, AS&T Lifecycle Management; Biological Method Expert
Job in
Gaithersburg, Montgomery County, Maryland, 20883, USA
Listed on 2026-07-09
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-07-09
Job specializations:
-
Research/Development
Regulatory Compliance Specialist, Biotech Research
Job Description & How to Apply Below
Responsibilities
- Provide technical analytical expertise for analytical activities of the Gaithersburg antibody laboratory and late-stage/commercial projects across a global network.
- Design and perform method validations and transfers; manage method lifecycle activities (e.g., exchange of critical reagents, method performance, and laboratory investigations); potential hands‑on laboratory work required.
- Participate in strategic and technical cross‑functional discussions with CMC team members and external partners.
- Evaluate and review technical and regulatory submission documents for approval and market launch of development products.
- Serve as Analytical SME for regulatory filings; support responses to health authority questions and regulatory submission questions.
- Advanced university degree (Biology, Chemistry, Pharmacy, Biotechnology, or related) and 10+ years in a regulated pharmaceutical environment.
- Expertise in chromatographic, spectroscopic, electrophoretic, immunoassay, and molecular biology techniques for analysis of mAbs/ADCs.
- Hands‑on experience with assay development, method validation (design and performance), and data/statistical evaluation.
- Strong CMC background for late‑stage development and commercial biological products.
- In‑depth knowledge of ICH guidelines, GMP regulations, and industry best practices.
- Proven regulatory filing experience for biologicals (IND/IMPD, BLA/MAA) and interactions with health authorities.
- Experience working in intercultural, cross‑functional, global teams.
- Structured working style; ability to break down complex challenges and plan timelines/interdependencies.
- Highly motivated; able to work in a fast‑paced, evolving environment.
- Experience managing method validation and transfer activities across external partners.
- Demonstrated ability to lead/support QC quality events and root cause investigations.
- Expected pay range: $146,300/year to $234,100/year + benefits, annual bonus & equity (variable).
Position Requirements
10+ Years
work experience
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