Manufacturing Specialist, GMP
About Clade Therapeutics
Clade Therapeutics is a well-funded, early-stage cell therapy company developing novel cell-based medicines for the treatment of cancer and other devastating diseases. The company was recently founded by an exceptional group of academic leaders and successful bioentrepreneurs. The Company works at the convergence of stem cell biology, immunology, regenerative medicine, and gene editing to create the next-generation of stem cell-derived medicines.
We are passionate about delivering on the promise of cellular therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients.
Position Summary
The GMP Manufacturing Specialist will collaborate with the R&D and Process Development groups to develop manufacturing processes to support production of cell therapeutics for pre-clinical studies and human clinical trials. The Manufacturing Specialist will be responsible for cGMP production activities and executing cGMP process qualification and validation studies. Duties will include writing new Manufacturing Process documents and manufacturing-related SOPs, validation protocols/reports and other GMP documents that are necessary for ensuring compliance with applicable U.S., Canadian and global standards.
Responsibilities
- Work with the Process Development group to develop manufacturing processes for expansion and differentiation of PSCs. Perform technology transfer of manufacturing processes to internal and external cGMP manufacturing teams as needed.
- Prepare specifications for equipment to support cGMP manufacturing. Procure equipment and support validation of equipment including writing IQ/OQ/PQ protocols and working with the team to execute validation studies and write validation reports. Prepare SOPs for equipment operation, maintenance and calibration.
- Work with Quality Assurance to prepare documentation to support cGMP manufacturing including raw material specification (RM), manufacturing procedures (MP) and related Standard Operating Procedures (SOPs).
- Participate in required cGMP training activities including training on required SOPs and manufacturing procedures.
- Prepare protocols for aseptic process qualification studies and process engineering runs. Work with the manufacturing team to execute qualification/validation studies and prepare documentation and reports for review by Quality Assurance and manufacturing staff.
- Work with the manufacturing team to produce Cell Drug Substance and Product for non-clinical studies and human clinical trials by procuring raw materials, preparing manufacturing facility/equipment, and executing the approved MP. Work with Quality Assurance to ensure completion of all associated documentation to support cGMP compliance.
- Work with Analytical Development and Quality Control to develop in-process testing plans. Assist in the development of appropriate analytical methods as needed.
- Support Quality Assurance documentation functions for cGMP production, in-process testing, and release testing of cell therapies. Work with QA to address quality events including deviations, CAPAs, OOS and other failure investigations as needed.
- Support cleanroom operations including review and tracking of equipment records for PM/calibration and cleanroom maintenance and cleaning.
Qualifications
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Corporate Values
- Patients First – Proactively and constructively engage to deliver results for those in need. “Begin with patient’s success in mind”
- Communication and Respect – Foster open exchange with colleagues and collaborators. Seek to understand and treat people with courtesy. “Better together”
- Integrity & Excellence – Act honestly and ethically to seek the truth. Courageously doing the right thing – take smart risks and make tough decisions in pursuit of exceptional outcomes. “Get it done right”
Clade Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, gender, age, religion, national origin, disability, veteran status, sexual orientation or any characteristic protected under applicable law.