Associate Director, AS&T Lifecycle Management (Biological Method Expert)

Gaithersburg, US | full time | Unlimited | Job ID: 11546

About the Role:

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.

Your Contribution:
• 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 the Analytical SME by providing expert knowledge for regulatory filings, as well as contributing expertise to questions from health authorities and responses to regulatory submissions

A Good Match:
• 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 chromatographic, spectroscopic, electrophoretic, immunoassay and molecular biology techniques for the analysis of mAbs/ADCs
• 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

Preferred Qualifications:

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

Your benefits and remuneration:

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.

Do you have any questions?

Please contact Yushen Chang (Talent Acquisition) or [email protected] with reference to the job ID.