PACT Pharma
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Associate Director, Reagent Manufacturing

Upstream Operations


PACT Pharma is an exciting, well-funded clinical stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient’s individual tumor and engineering T cells to kill that specific tumor.

If you desire a stimulating fast paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team.  We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer! 

We are in the San Francisco bay area, the heart of the world’s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants. 

We are currently recruiting for an Associate Director of Reagent Manufacturing who will report to the VP of Operations and continue advancing PACT Pharma’s cutting edge engineered cell product. This will be a unique opportunity to see your ideas rapidly translate into the clinic and impact patient lives.  This person will oversee and lead all aspects of Reagent Manufacturing for PACT Pharma's internal production and testing. They will have the required experience and drive to scale a small pilot operation to support rapid volume growth, oversite of CMO partners, and enhancing the existing processes and infrastructure to deliver robust and high-quality products to internal customers. This detail oriented and process focused leader will leverage best practices and industry leading approaches to ensure production schedules are met while achieving critical cost and quality objectives. The ideal candidate will be action oriented and fluent in the setup and operation of regent operations including workflow optimization, QC method implementation, process validation, and efficient inventory utilization.

Responsibilities:

  • Manage the overall process of formulation, QC, and packaging resources
  • Ensure compliance to quality system requirements
  • Create required documentation: protocols, test reports, SOPs, product specifications, manufacturing controls, and performance verifications
  • Develop and maintain a roadmap to build schedule to meet internal and external consumables demand
  • Work with internal cross-functional teams to ensure a continuous product supply and maintain procedural control of the entire reagent supply chain
  • Oversee the scale up of production processes in an efficient and cost-effective manner
  • Assist the transfer of new products or processes into Manufacturing
  • Participate in new vendor evaluation, qualification, and integration
  • Supervise, develop, and mentor of direct reports

Qualifications:

  • Bachelor's degree in Biology, Chemistry, or related field or comparable industry experience with 10+ years of experience in manufacturing of life sciences reagents for use in research and clinical applications
  • Extensive knowledge of manufacturing work center administration; including BoM management, routing hours, and resource scheduling
  • Candidates with advanced degrees will be preferred
  • Significant experience in production of molecular biology products
  • Proficient with scaling and automating production
  • Understanding of Quality Control methods development and implementation
  • Ability to drive supply chain, production planning, and inventory management of complex multi-level reagent kits
  • Working understanding of statistical methods used in characterization and process control
  • Application of LEAN and Six Sigma principals in a reagent manufacturing setting

PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.

 

 

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