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EPM Scientific · 1 day ago

Associate Director/ Director of Upstream Process Development (Biologics)

Southborough, MA

Full-time

Onsite

Lead/Staff, Director/Executive

$170K/yr - $220K/yr

8+ years exp

EPM Scientific is seeking an Associate Director of Upstream Process Development to lead upstream process development activities for biologics programs. This role involves overseeing a team of scientists and engineers to drive innovation and scalability from early development through to clinical and commercial manufacturing.

BiotechnologyRecruiting

Hiring Manager

Reily Mowen

Responsibilities

Develop and execute upstream process development strategies aligned with program timelines and regulatory requirements

Provide technical leadership for cell culture optimization, scale-up, and process characterization

Lead and mentor a team of scientists and engineers, fostering a culture of collaboration and scientific excellence

Allocate resources effectively across multiple projects

Design and optimize mammalian cell culture processes for high-yield biologics production

Oversee bioreactor operations (bench-scale to pilot-scale) and implement process analytical technologies (PAT)

Support process characterization and validation studies for late-stage programs

Partner with downstream, analytical, and quality teams to ensure seamless integration of upstream processes

Drive tech transfer to internal or external GMP manufacturing sites

Author and review CMC sections for IND/BLA submissions

Ensure compliance with cGMP, ICH, and other regulatory guidelines

Qualification

Mammalian cell cultureBioreactor operationsTech transfer to GMPDOEQbD principlesProcess characterizationPerfusionFed-batch processesRegulatory filings knowledgeLeadership skillsProject managementCommunication skillsCollaboration abilities