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

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

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 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

   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.

Inspired? Join our team of pioneers and bright, open minds. From our founders to our scientists to our business professionals, we think out-the-box, believe in ourselves, work agile and stand accountable.

Together, we usher in a new era of immunotherapies and work on realizing our vision.

Do you have any questions?

Please contact Yushen Chang (Talent Acquisition) or jobs@biontech.de with reference to the job ID.

BioNTech, our story.

At BioNTech, we are more than just a biotechnology company - we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encouragecreativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important - it's a match!