Senior Director, Bioanalysis

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Based in Cambridge, MA and Gaithersburg, MD. We are committed to improving the health of people worldwide with our fundamental research and our work in the area of development of immunotherapies utilizing the full potential of the immune system to fight cancer, infectious diseases and other serious diseases. We believe in scientific rigor, innovation and passion as driving forces. BioNTech was founded by scientists and physicians to translate science into survival by combining fundamental research and operational excellence.

With decades of deep immunology expertise and experience in developing and optimizing mRNA as part of its broad suite of novel technologies, the company is working with the global community to defeat life-threatening and serious diseases such as cancer, COVID-19, malaria and tuberculosis. The first ever approved mRNA vaccine was created in the labs of BioNTech in Mainz, Germany. A fully integrated immunotherapy powerhouse. We remain focused on bringing our broad pipeline of next-generation immunotherapies and vaccines to people around the world to address cancer, infectious diseases, as well as a growing list of other medical conditions. To accomplish this, we continue to be deeply rooted in science and academic research while also having built a fully integrated, global immunotherapy company with cGMP and GMP manufacturing facilities anchored around deep expertise in immunology and complemented by an expanding set of capabilities.
 

 

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 s