Senior Director, Bioanalysis

Senior Director, Bioanalysis

Position Summary

The candidate will lead Bioanalysis team working on antibody-drug conjugate (ADC) research programs and supporting clinical development of ADC therapeutics. The position requires close collaborations with various functional and program teams and outside CDMOs.

Primary Responsibilities

• Lead the development and implementation of analytical methods for the analysis and characterization of ADCs and peptide-drug conjugates (PDCs)
• Plan and oversee daily analytical activities of Bioanalysis team
• Coordinate analytical activities with the program and functional teams to meet overall development timelines
• Generate study reports, interpret data, and communicate experimental results to functional and program teams
• Develop analytical methods for PK studies, analyze PK samples, and report the PK study results
• Support Process Development team by developing analytical methods and protocols for GMP manufacturing of ADCs and PDCs
• Support Process Development team by developing formulations of ADCs and PDCs for pre-clinical studies and GMP manufacturing
• Work cross-functionally within the R&D organization

Requirements: (No more then 5)  

• Ph.D. in Analytical Chemistry or a related field with 10+ years of industry experience in drug discovery and development
• Strong hands-on experience in ADC analytical method development, analysis, and characterization
• Deep understanding of chromatography-based methods, including RP, SEC, HIC, HILIC, LC-MS (e.g. triple quadrupole and QTOFs)
• Strong experience in PK analysis, ADME, DMPK, and MetID
• Excellent interpersonal and communication skills
• Must be able to work in a team and collaborative environment

Preferred Requirements:

• Experience in formulation development of liquid or lyophilized biologic drug products is a plus
• Knowledge in CMC regulations is desirable

Benefits for you:

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

• 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

• Sitterstream: 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.

BioNTech is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices laws. BioNTech does not tolerate discrimination against employees or applicants because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including gender, pregnancy, sexual orientation, and gender identity), age, physical or mental disability, citizenship, past, current, or prospective service in the uniformed services, genetic information, or any other characteristic protected under applicable federal, state, or local law.

If you are unable or limited in your ability to use or access BioNTech’s online application tools due to a disability, you can request reasonable accommodations by calling 1-857-228-6231or by e-mailing [email protected]. Thank you for your interest in BioNTech.