[Hiring] Associate Director, Drug Product Development & Manufacturing @Entrada Therapeutics

Role Description

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

Responsibilities

• Lead drug product formulation, characterization, process development, technology transfer, scale-up, and manufacturing activities for early to late-stage pipeline programs.
• Develop, author, review, and approve technical study protocols, reports, and documentation related to development and manufacturing.
• Serve as a subject matter expert and provide direct oversight for drug product manufacturing activities at CDMOs including formulation, aseptic filling, visual inspection, manufacturing investigations, and change controls. Responsible for driving execution of current production plan at CDMOs with long-term vision.
• Provide PIP/on-site oversight at CDMOs during manufacturing campaigns to support disciplined execution, ensure quality, and deliver timely technical input.
• Facilitate timely execution, disposition, and release of drug product batches through detailed technical review of master batch records, executed batch records, and other cGMP documentation.
• Author and review deviation reports, investigations, and change controls.
• Author/review related sections in regulatory filing documents (IND, IMPD, NDA, etc.).
• Collaborate cross-functionally across a wide variety of teams, including Discovery, Chemistry, DS Development & Manufacturing, Analytical Development & Quality Control, Quality Assurance, Clinical Operations, and CRO/CDMOs.

Qualifications

• MS in a scientific related discipline with 8+ years of biotech or pharmaceutical experience preferred.
• Experience in parenteral drug product formulation development and manufacturing, with demonstrated ability to provide CDMO oversight. Direct experience with intravitreal injections is a plus.
• Strong knowledge of sterile manufacturing and fill-finish operations with demonstrated experience with batch records, deviations, change controls, and tech transfer. Late-stage experience is a plus.
• Demonstrated ability to lead authoring and review of technical study protocols and 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 and working effectively across functions.
• Desire to work in an innovative and collaborative environment.
• Ability to travel (estimated 20% or as needed) to CDMOs for supporting manufacturing campaigns.

Benefits

• Comprehensive 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 aligned to your working model.