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 located in the San Francisco bay area. 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 a Bioprocess Manufacturing Specialist who will join our Manufacturing Team and continue advancing PACT’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.
- Perform cGMP processing and documentation required to produce and assess safe and efficacious products within an ISO clean room environment using aseptic techniques as applicable
- Develop, update, and implement production and large-scale manufacturing procedures to optimize processes and regulatory requirements, such as standard operating procedures, batch records, etc.
- Resolve or partner with cross-functional teams, such as Process Development (PD) and Manufacturing Sciences and Technology (MSAT), to scale-up and investigate technical issues, as well as maintenance of production equipment
- Contribute to and/or own quality records (deviation, change controls, corrective and preventative actions) and complete in a timely manner
- Provide justification and review existing operational and process discrepancies and provide technical expertise to improve procedures
- Exercise a continuous improvement mindset to create or enhance Manufacturing tools, processes, documents, etc.
- Provide manufacturing expertise for studies related to equipment and process performance, comparability, and reliability
- Contribute to operating equipment specifications and improve manufacturing techniques
- Evaluate, select and order equipment that is most appropriate and cost effective for the manufacture of company products
- Bachelor’s degree in a biologics, biotechnology, engineering, or related field with 5+ years of manufacturing or applicable experience in a cGMP environment
- Clean room, aseptic, and/or biological safety cabinet experience required
- Experience in one or more of the following required:
- Cell counting, cell culture/fermentation, chromatography, filtration, single use technologies
- Ability to communicate clearly and concisely, both verbally and in the form of written reports
- Effective in solving and communicating manufacturing-related issues to relevant stakeholders
- Demonstrated ability on filling the gaps between business requirements and suggesting reasonable alternatives when necessary
- Ability to build partnerships with cross-functional teams without formal authority
- Effective organizational skills, time management, and ability to coordinate workload and meet established deadlines
- Flexible and able to adapt to company growth and evolving responsibilities
- Ability to work a flexible schedule that may include nights, weekends and/or holidays
- GLP and GMP experience a plus
Physical Demands :
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear. The employee is regularly required to climb or balance; stoop, kneel, or crouch. The employee is frequently required to lift and/or move up to 30 pounds. Non-absorbent gowning or laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryo gloves must be used when working with liquid nitrogen.
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.