Senior Manager, Laboratory Operations, Gene Editing

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. In principle, this technology can be used to treat any cancer type. 

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 searching for a Senior Manager, Laboratory Operations who will initially report to the Director of Gene Editing and anchor a newly formed production team focused on operationalizing PACT’s cutting edge engineered cell product. This will be a unique opportunity to design and implement new operational processes and see your contributions to PACT’s personalized therapy directly translate into the clinic and impact patient lives.

The ideal candidate should be experienced in both production laboratory best practices as well as the latest molecular cloning techniques and mammalian cell culture. She/he will lead this core operations team in implementing robust and scalable procedures as a hands-on player/coach.

The candidate should enjoy operating in an exceptionally dynamic and cooperative environment and will communicate results to and coordinate efforts with a larger cross-disciplinary team of immunologists, biologists, engineers, and bio-informaticians.

Responsibilities:

• Lead, mentor, and grow a team of research associates responsible for generating constructs and engineering cells to express patient-derived T cell receptors.
• Serve as the sole point of contact and process owner for the Gene Editing portion of PACT’s production pipeline.
• Define and implement operational protocols and best practices.
• Manage workflows, materials, and resources to ensure the quality and timely delivery of plasmids and T cells.
• Oversee processes to identify and implement process improvements focused on quality, turnaround time, and cost.
• Collaborate with process development and engineering to scale your operation by automating wherever possible.
• Author SOPs and work instructions in accordance with PACT’s quality management system and provide data for regulatory documentation to support clinical development.

Qualifications: 

• Bachelor’s or master’s degree with 6+ years of experience or Ph.D. with 3+ years of industry experience with a career focus in cell or molecular biology, biochemistry, or molecular genetics.
• 3+ years’ experience managing a production laboratory operation
• Extensive hands-on experience with nucleic acid purification, primer design, PCR and standard cloning.
• Hands-on experience with mammalian cell culture and sterile technique.
• Experience operating within a formal quality management system.
• Communicate clearly and concisely, both verbally and in the form of written reports.
• Demonstrated ability to implement laboratory best practices, continuous improvement methodologies, and lean manufacturing principles.
• Highly goal-driven and have demonstrated the ability to focus on time-sensitive objectives.

An incumbent with experience in the following areas is a plus:

• cGMP or ISO 13485 production experience.
• Experience in a turnaround time-sensitive production environment.
• Experience with liquid handlers/automation equipment.
• Experience with complex LIMS, informatics, or data management
• Mammalian cell culture and transfection, ideally primary human T cells.
• High-throughput sequencing sample preparation and analysis. 

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.