Sr. Manager, Drug Product Development & Manufacturing

The role

The Associate Director, Drug Product Development & Manufacturing leads drug product manufacturing activities to support clinical stage assets and pipeline programs. This role ensures successful execution of clinical manufacturing operations for parenteral drug products and partners cross-functionally to deliver clinical supply.

What you will do

• Lead drug product formulation, characterization, process development, technology transfer, scale-up, and manufacturing activities.
• Develop, author, review, and approve technical study protocols, reports, and documentation.
• Provide direct oversight for drug product manufacturing activities at CDMOs.
• Drive execution of current production plan at CDMOs.
• Provide PIP/on-site oversight at CDMOs during manufacturing campaigns.
• Facilitate execution, disposition, and release of drug product batches through technical review.
• Author and review deviation reports, investigations, and change controls.
• Author and review related sections in regulatory filing documents.
• Collaborate cross-functionally across various teams.

Required qualifications

• Experience in parenteral drug product formulation development and manufacturing.
• Demonstrated ability to provide CDMO oversight.
• Strong knowledge of sterile manufacturing and fill-finish operations.
• Demonstrated experience with batch records, deviations, change controls, and tech transfer.
• Demonstrated ability to lead authoring and review of technical study protocols, reports, manufacturing documentation, and regulatory documents.
• Knowledge of cGMP, ICH, FDA and EMA guidelines regarding sterile drug product development and manufacturing.
• Excellent verbal and written communication skills.
• Ability to stay highly organized while managing multiple programs in a fast-paced environment.
• Ability to travel (estimated 20% or as needed) to CDMOs.

Nice to have

• MS in a scientific related discipline with 6 + years of biotech or pharmaceutical experience
• Direct experience with intravitreal injections
• Late-stage experience

Benefits

• Health, dental and vision coverage
• Life and disability insurance
• 401(k) match
• Paid, gender-inclusive parental leave
• Holistic support for health and well-being
• Education reimbursement
• Discretionary time off
• Commuting benefits

About the company

Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets. The company is advancing a development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases.