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

BioNTech AG -
Gaithersburg, MD

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Job Details

Full-time
$146,300 - $234,100 a year

Qualifications

Biology
FDA submissions
Statistics
Infrared Spectroscopy (IR)
Pharmaceutical laboratory environment
Defect analysis
High-performance liquid chromatographs
Protein analysis (analytical chemistry specialty)
Biotechnology
Investigational new drug (IND) applications
Statistical analysis
ICH guidelines
Laboratory regulatory affairs
Pharmaceutical company experience
Pharmaceutical analysis
Pharmacy
Mass spectrometers (MS)
Chemistry, manufacturing & controls
Chemistry
Regulatory submission editing and review
Communication with regulatory authorities for clinical trials
Verification of laboratory test methods
Quality control experience within pharmaceutical industry
International corporation experience
GMP for research safety and compliance
Root cause analysis
Senior level
Cross-functional collaboration
Test validation method
Cross-functional communication

Full Job Description

Gaithersburg, US | full time | Job ID: 11547

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 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 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

Preferred Qualificaitons:

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

Your 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 [email protected] 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, encourage creativity, 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!

Inspired? Become part of #TeamBioNTech.

BioNTech, the 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, encourage creativity, 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 views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!

BioNTech - As unique as you

www.biontech.com

Apply Now

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