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Process Lead Engineer

Employer
PACT Pharma
Location
94080, South San Francisco
Salary
Salary + bonus + benefits
Start date
Dec 10, 2018

View more

Discipline
Manufacturing & Production, Operations, Process
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

PACT Pharma is an exciting, well-funded biotechnology company, advancing to clinical studies in 2019 with facilities and laboratories in South San Francisco, CA.  PACT is developing personalized adoptive T cell therapies for the eradication of solid tumors.  We are in the San Francisco bay area, in the heart of the world’s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants 

PACT is developing tumor-mutation targeted T cells tailored for each patient. Tumor mutation (neoE) targeting is programmed into the patient’s own T cells to seek out & kill the tumors. Using (non-viral) precision genome engineering, the neoE-targeted Tcell receptors (TCRs) replace the endogenous TCR of fresh CD8 and CD4 T cells collected from that same patient followed by minimal expansion in closed systems for re-infusion into the patient. These patient-specific neoTCR-P1 cells are formulated to immediately kill all neoantigen-expressing tumors, together with a deep reservoir of ‘ready-to-go’ neoTCR-P1 cells for long term persistence and capable of rapid expansion to prevent future cancer recurrence.

We are currently recruiting for a Process Engineer Lead candidate. This position will report to the Head of Manufacturing and will be based in South San Francisco.

Process Engineer Lead

This position is responsible for supporting the activities involved in the transfer of the GMP plasmid DNA manufacturing process and equipment from the CMO site into the PACT manufacturing facility to support the clinical immunotherapy products.   This position will be “hands-on” with the manufacturing operations, facilities, and equipment. Once the process and equipment are implemented, this position will support the manufacturing operations within the PACT GMP facility.   The candidate will provide technical expertise to manage multiple plasmids and support the technical transfer of processes into the multi-use facility.  The candidate will have experience with small scale equipment and implementation into GMP facilities.   This position will support the completion of all goals and objectives of manufacturing. 

It is expected that the Process Engineer will work closely with other corporate functional areas as well as outside vendors to ensure deliverables are met. 

 Duties and Responsibilities -- Essential Functions:

  • Responsible for managing the transfer of plasmid DNA processes from the CMO site into the PACT GMP facility
  • Provide leadership and training of the manufacturing staff on the pDNA process and equipment
  • Support the manufacturing staff during technical transfer, start up and in routine processing
  • Works effectively with the other operational groups to ensure that all GMP requirements are met for the implementation of pDNA into the PACT facility
  • Works closely with the Supply chain, Quality Control, Validation, Engineering, Quality Assurance, and Regulatory Affairs functions internally to ensure the facility meets all appropriate standards and all pDNA process are performed per GMP requirements
  • Coordinates Manufacturing timelines and deliverables through the CMC team, Program Management and other functions, as appropriate
  • Provide support to the equipment implementation and qualification
  • Provides, writes, and reviews relevant documentation for pDNA operations and equipment
  • Other duties and responsibilities as assigned
  • Position may require some travel​

Minimum Qualifications:

  • MS or PhD in biological sciences or engineering or BS degree in scientific field plus at least 10 years of experience
  • Minimum of 10 years of experience in Manufacturing or Development roles with more than 5 years in a drug product development and manufacturing function at a biotechnology or pharmaceutical company with direct involvement in the process to achieve early development milestones and successful product licensure
  • Experience in leading a team in transferring a process from a CMO into a new facility
  • Experience in leading meetings, teams, CMOs
  • Demonstrated management experience including employee development and leadership
  • Experience with issues related to manufacturing is required
  • Knowledge of current requirements for GLP, cGMP, and GCP is also required
  • Direct experience with regulatory submissions
  • Forward-thinking and creative with high ethical standards
  • Team player with leadership skills with ability to influence others to achieve successful regulatory filings and meetings.
  • Well organized and self-directed
  • Strong interpersonal skills with an ability to communicate to people at all levels of an organization 

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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