e are currently searching for a Senior Manager, Laboratory Operations who will initially report to the Director of Protein Sciences 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 high throughput protein production technologies. She/he will lead this core operations team in implementing robust and scalable procedures and lead the team as a hands-on contributor and manager.
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.
- Lead, mentor, and grow a team of research associates responsible for generating patient-specific libraries of protein
- Serve as the sole point of contact and process owner for the Protein Sciences 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 protein batches
- 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
- Bachelor’s or master’s degree with 6+ year experience or Ph.D. with 3+ years 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, cloning procedure, protein expression and purification
- Hands-on experience will mammalian cell culture and sterile technique
- Experience with protein analytics and quantification techniques
- 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 production experience
- Experience in a turnaround time-sensitive production environment
- Experience with liquid handlers/automation equipment
- Experience with complex LIMS, informatics, or data management