Associate Director, Drug Substance Development & Manufacturing

About the role

The Associate Director of Drug Substance Development and Manufacturing will lead and manage late-stage drug substance development for Entrada’s novel pipeline programs. This role will be instrumental in supporting development activities for clinical and commercial batches and ensuring validation parameters for manufacturing batches.

Responsibilities

• Facilitate timely execution, disposition, and release of intermediate/drug substance batches through detailed technical review of master batch records, executed batch records and other cGMP documentation.
• Partner with internal and external Quality Assurance, Quality Control and Technical Operations teams to execute late-stage development activities such as Process Characterization and Process Performance Qualifications.
• Act as a person-in-plant for smooth execution of critical manufacturing activities for clinical and commercial batches.
• Conduct risk assessments and develop mitigation strategies for manufacturing-related issues.
• Identify and resolve manufacturing issues and escalate appropriately to internal and/or joint governance if required.
• Implement and manage the Continuous Process Verification (CPV) program to ensure manufacturing processes remain in a constant state of control and meet validated parameters.
• Author/review change controls to introduce process improvements through the lifecycle of programs from Phase 1 through Phase 3/validation and commercialization.
• Work closely with other internal functions including chemistry, analytical, quality control, quality assurance, DP, and regulatory affairs to ensure programs are effectively supported and high-quality standards maintained.
• Partner with Entrada team for CDMO due diligence during new CDMO selection to vet capabilities, risks and investments required.
• Author/review related sections in regulatory filing documents (IND, IMPD, NDA, BLA, MAA, etc.).
• Other tasks as assigned or as required for a given program.

Necessities

• Master’s or suitable advanced degree in organic chemistry or other scientific or engineering discipline with 8+ years of related experience in pharmaceutical industry.
• Demonstrated proficiency in process development, tech transfer, scale-up, GMP manufacturing DS for clinical, and commercial supplies.
• Proficient in managing activities and resolving manufacturing challenges at CDMOs during routine cGMP manufacturing and process validations.
• Experienced in onboarding/managing/collaborating with CDMOs, raw material suppliers, testing partners, and other production partners.
• Hands-on experience in SPPS/SPOS, downstream purification and lyophilization is highly preferred.
• Demonstrated ability to develop and maintain production timelines and budgets.
• Up-to-date with industry practices and regulations (e.g. GxP, ISO, ICH, etc.) across multiple health authorities (e.g. FDA and EMA).
• Ability to interpret and relate Quality standards for implementation and review.
• Strong project management, interpersonal, communication, and problem-solving skills preferable.
• Ability to communicate clearly and professionally both in writing and verbally.
• Ability to travel up to 20% (domestic and international).

What We Offer

• Meaningful Work
• Fair Rewards
• Real Support

Equal Opportunity Employer

Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law.