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Location

Gaithersburg, MD | United States

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Job description

Director, CMC & Validation MSAT

Primary responsibilities include :

Reporting to the Senior Director of MSAT (Gaithersburg, MD), the CMC & Validation Director will work to develop process characterization strategies, support Regulatory submissions (IND/ BLA), and be accountable for best-in-class validation strategies of cell therapy products in the BioNTech Gaithersburg facility to ensure successful transition from Development to Operations.

This person will identify and optimize key business processes related to CMC, validation, lifecycle management, lead internal and external benchmarking of CMC and validation processes and define standard ways of working, drive continuous improvement and simplification projects for the manufacture of Cell & Gene therapy products to patients for clinical trials ensuring cost, schedule and quality targets are met. This role is also accountable for the manufacturing sciences and technology advancement of Cell and Gene Therapy to ensure products are fit for technical feasibility, commercialization and meets CMC regulatory requirements.   This role will work in close collaboration and partnership with the Development team to advance product development, and with key stakeholders for product supply including Global MS&T, Regulatory, Quality, Supply Chain, and other regional and global functions.

This position requires working on-site as an essential function.

• Support planning, preparation, and internal review of CMC documentation for Clinical Trial Applications, IND submissions and amendments, marketing applications, supplements, variations and other communications with regulatory authorities (e.g., briefing documents for meetings) 
• Attend project team meetings and provide CMC-related regulatory guidance to other functional areas, including Manufacturing, Quality, and Commercial Operations
• Manage preparation and internal review of Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidance’s.
• Perform life cycle management for marketed products on a global basis, including regulatory impact assessments and preparation of CMC documentation for variations and other post marketing submissions.
• Develop and maintain current CMC regulatory knowledge in countries/regions of interest and advise management of significant developments for the Gaithersburg portfolio.
• Create the side Validation Program to meeting regulatory expectations and establish validation systems aligned with global discussions and standards.
• Accountable for site product control strategies, process validation, and product shipping validation.
• Proactively and effectively manage and problem solve constraints and performance issues to keep business unit performance on target
• Provide leadership and direction to the business unit to ensure its performance is in line with the Business Plan and the Quality Management System and therefore meeting the requirements of all codes, regulations.

Requirements: 

• Requires Bachelors’ degree in a chemistry/biology/engineering discipline. Master’s degree preferred, but not required. MBA with science/engineering background welcome.
• Excellent communication and leadership skills, ability to effectively work with and lead cross-functional, global teams.
• Experience in validation, protocol generation, execution, and approval across various stakeholders.
• Prior experience with Pharma/Biopharma process development/quality/manufacturing preferred, but not required.
• Proficient knowledge of manufacturing processes, CMC requirements, process technologies and regulatory requirements
• Experience with change control,
• Excellent communication, interpersonal and collaboration skills.
• Strong organizational, problem solving and project management.
• Willingness to think outside of the box and adapt best practices in a constantly evolving environment.
• Experience in biopharmaceutical operations.

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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.

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