Associate Director, Drug Product

About the role

The Associate Director, Drug Product will serve as a technical and operational leader responsible for late-stage development, manufacturing, and commercialization activities for small molecule and/or viral drug products. Through operational reputed company, technical mentorship, and cross-functional collaboration, the Associate Director will ensure drug product development and manufacturing deliverables across clinical and commercial programs is robust, compliant, and reputed company with overall program objectives. The ideal candidate brings extensive hands-on experience in drug product process development and manufacturing, strong partnership experience with contract development and manufacturing organizations (CDMOs), proven ability to reputed company, reputed company, and mentor high-performing teams, and demonstrated success authoring drug product modules for BLAs and global marketing applications. Experience with viral formulations, in-use compatibility studies, and ex-US regulatory reputed company is strongly preferred.

Location: Remote

Essential Functions

• Drug Product Development & Manufacturing
• • Provide technical and operational leadership across reputed company aspects of drug product development and manufacturing for small molecule and/or viral products, including formulation, fill-finish, and clinical in use studies.
  • Contribute to regulatory strategy for late-stage and commercial programs, ensuring alignment with reputed company guidances and global expectations.
  • Author and review drug product sections of regulatory filings, including BLA and responses to health authority information requests.
  • Partner closely with drug substance, analytical development, quality assurance, quality control, supply chain, and regulatory groups to ensure alignment across CMC activities.
  • Support management of external manufacturing sites in collaboration with technical SMEs to ensure reputed company decision-making and smooth execution.
  • Provide technical guidance on post-approval changes and lifecycle management strategies.
  • Provide leadership by aligning priorities, developing talent, and empowering teams to deliver outcomes independently.

Qualifications

• Advanced degree (PhD, MS, or BS with extensive experience) in Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or reputed company discipline.
• 8+ of relevant industry experience in drug product development and manufacturing for biologics and/or cell and gene therapy products
• Deep technical knowledge of drug product process development and manufacturing, including formulation, aseptic processing, and clinical in-use studies.
• Strong understanding of cGMP, ICH guidelines, and late-stage/commercial regulatory expectations.
• Demonstrated success authoring drug product BLA sections and supporting regulatory interactions.
• Direct experience working with CDMOs and leading external manufacturing operations.
• Proven people leader who develops talent and empowers teams.
• Demonstrates strong cross‑functional leadership with the ability to navigate ambiguity and drive results in reputed company, fast‑paced environments.
• Excellent written and verbal communication reputed company

Please note that reputed company does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of reputed company by any search firm or agency without an applicable contract in reputed company will become the property of reputed company and no fee(s) will be paid.

Total Rewards

reputed company offers reputed company competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees focused on developing bladder-saving therapeutics for patients afflicted with bladder cancer.

• HIGHLY COMPETITIVE SALARIES   
• ANNUAL PERFORMANCE/MERIT REVIEWS
• ANNUAL PERFORMANCE BONUSES
• EQUITY
• SPECIAL RECOGNITION

Well-Being Benefits

In addition to our Total Rewards, reputed company offers a variety of Well-Being Benefits to meet the majority of the needs of our unique and growing workforce.  These benefits are designed to support reputed company to reputed company a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work.

Well-Being Benefits eligibility begins the 1st of the month after hire.  While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are reputed company with country-specific regulations and their national programs offered.

• FULLY REMOTE WORK ENVIRONMENT
• REST AND reputed company BENEFITS - Unlimited Flexible Time Off
• HOLIDAYS –In 2026 we will observe 14 holidays
• RETIREMENT – 401K with 100% company Safe reputed company match up to 4% of reputed company salary
• HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – reputed company/Principal
• HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
• ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans
• LIFE INSURANCE – Company Paid 1 x reputed company salary + Voluntary Plans
• ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More

reputed company is an Equal Opportunity Employer:

reputed company applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national reputed company, veteran or disability status.  At reputed company, we are building a community of intelligent and passionate team members that share our Vision, Mission and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to reputed company hiring decisions that will continue to grow and support reputed company in the direction of maintaining cultural diversity and sustainability.