Associate Director, Projects & Strategy, Analytical Sciences & Technology (AS&T) (Gaithersburg, MD, US, MD 20878)

Biopharma Careers; Gaithersburg (MD); On-site; USD 146,000 - 234,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401K with match

Paid Time Off

Tuition Reimbursement

Job summary

BioNTech in Gaithersburg, MD is seeking an Associate Director, AS&T Projects & Strategy to coordinate analytical activities across internal and external partners, ensuring alignment with development strategies and regulatory expectations.

You will lead analytical teams, drive the CMC Module 3 dossier, and collaborate with Regulatory Affairs, CMC, and Quality to support late-stage programs and potential product launches. A senior leader with deep regulatory knowledge is required.

Qualifications

• Advanced degree in Biology, Chemistry, Pharmacy, Biotechnology or related field.
• 10+ years in a regulated pharmaceutical environment.
• Experience in analytical functions (AS&T, QA, Analytical Development) with mAbs/ADCs.

Responsibilities

• Represent the analytical function within cross-functional project teams and act as the primary interface for CMC and stakeholders.
• Coordinate analytical deliverables across internal functions and external partners.
• Shape analytical control strategy with Regulatory Affairs, CMC and Quality to meet regulatory expectations.
• Provide leadership and oversight for analytical activities and communicate progress, timelines, risks, and challenges.
• Maintain end-to-end ownership of analytical components of the CMC Module 3 dossier, including docs and lifecycle maintenance.

Skills

Leadership

Cross-functional collaboration

Regulatory knowledge

Project management

Stakeholder management

Communication skills

Education

Advanced degree in Biology/ Chemistry/ Pharmacy/ Biotechnology

Job description

Gaithersburg, US | full time | Job ID:11533

About the Role:

As Associate Director, AS&T Projects & Strategy, you will play a key role in advancing our late-stage protein pipeline for Monoclonal Antibodies (mAbs) and Antibody-Drug Conjugates (ADCs) within the Analytical Sciences & Technology (AS&T) organization. In this position, you will serve as the main point of contact and oversee the coordination of all analytical activities across both internal teams and external analytical partners. In addition, you will represent the analytical network within the cross-functional late-stage CMC team, helping drive development programs forward toward commercialization.

Your Contribution:

• Represent the analytical function within cross-functional project teams and act as the primary interface for the CMC team and other key stakeholders.
• Coordinate analytical deliverables across internal analytical functions and external partners, ensuring alignment with the overall analytical development strategy.
• Shape and align the analytical control strategy in close collaboration with functions such as Regulatory Affairs, CMC, and Quality, ensuring compliance with regulatory expectations and health authority requirements.
• Provide leadership and oversight for analytical activities, ensuring transparent communication of progress, timelines, risks, and challenges to relevant stakeholders.
• Maintain end-to-end ownership of the analytical components of the CMC Module 3 dossier, including document preparation, review, and lifecycle maintenance.

A Good Match:

• An advanced degree in Biology, Chemistry, Pharmacy, Biotechnology, or a related scientific discipline, combined with over 10 years of experience in a regulated pharmaceutical environment.
• Broad experience within analytical functions, such as AS&T, Quality Control, or Analytical Development, with a focus on monoclonal antibodies (mAbs), multi-specific antibodies, and/or antibody-drug conjugates (ADCs).
• Strong track record in late-stage analytical development and commercial support for antibody-based products, ideally including experience with ADCs.
• Demonstrated leadership capabilities and solid experience in managing analytical projects.
• Deep understanding of relevant US and EU regulatory frameworks, including EMA and FDA requirements, CMC analytical development documentation, Good Manufacturing Practice (GMP), as well as compendial standards such as USP and Ph. Eur.
• Strong organizational skills, with the ability to analyze complex topics, break them down into manageable elements, and define timelines and dependencies accordingly.
• Proven ability to work effectively in intercultural, cross-functional, and global team environments.
• Excellent communication and stakeholder management skills.
• Highly motivated, adaptable, and comfortable working in a dynamic, fast-paced, and evolving environment.
• Experience supporting pre-approval activities, such as Pre-licensing Inspection (PLI) readiness, BLA preparation, and product launch activities, is considered an advantage.

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.

• 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
• … more! More details to be shared.

Located in the BioHealth Capital Region near Washington DC and ranked among the top biopharma hubs in the country, Gaithersburg, Maryland offers a unique and diverse cluster across industry, government, and academia for top talent and scientific innovation. As a pivotal player within the life sciences community, Gaithersburg is distinguished by its robust infrastructure and strategic location near the nation’s capital. The city’s strategic significance is amplified by its state-of-the-art manufacturing facilities that cater to the rigorous demands of the life sciences industry; Gaithersburg’s manufacturing sector is defined by advanced technologies and complies with the most stringent regulatory standards, ensuring the production of high-quality pharmaceuticals, biologics, and medical devices. In the coming years, Gaithersburg will continue to be a vital contributor to the future of medical science and technology.

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.