What are the responsibilities and job description for the Manufacturing Lead position at uBriGene Biosciences?
About the job
We are looking for a manufacturing lead (Associate Director/Manager) to join our Cell Therapy team. In this role, you'll be instrumental in leading the cell therapy clinical material production as well as the cGMP equipment and facility management. This is an opportunity to work with cGMP mindset to collaborate with cross functional team to pivot cell therapy product process transfer and production into cGMP manufacturing suites to ensure the clinical production success in full compliance with cGMP requirements.
Position title
Manufacturing Lead
Role:
The Lead will be responsible for transferring, implementing, and executing the manufacturing processes for cellular therapy programs in the cGMP manufacturing facility. Meanwhile, this Lead will be responsible for ensuring the cGMP facility in full compliance with cGMP requirements and support the regulatory as well as the client audits. This role requires extensive collaboration with internal and external teams. The successful candidate will need to have a deep understanding of cGMP requirements as well as sound scientific understanding and hands-on experience of cell therapy production process.
Responsibilities:
We are looking for a manufacturing lead (Associate Director/Manager) to join our Cell Therapy team. In this role, you'll be instrumental in leading the cell therapy clinical material production as well as the cGMP equipment and facility management. This is an opportunity to work with cGMP mindset to collaborate with cross functional team to pivot cell therapy product process transfer and production into cGMP manufacturing suites to ensure the clinical production success in full compliance with cGMP requirements.
Position title
Manufacturing Lead
Role:
The Lead will be responsible for transferring, implementing, and executing the manufacturing processes for cellular therapy programs in the cGMP manufacturing facility. Meanwhile, this Lead will be responsible for ensuring the cGMP facility in full compliance with cGMP requirements and support the regulatory as well as the client audits. This role requires extensive collaboration with internal and external teams. The successful candidate will need to have a deep understanding of cGMP requirements as well as sound scientific understanding and hands-on experience of cell therapy production process.
Responsibilities:
- Lead and execute cGMP- based activities in implementing the tech transfer of cell therapy processes and technologies into cGMP manufacturing facility.
- Lead and execute at-scale end-to-end processes in the cGMP facility to support regulatory submission and generate cGMP materials to support clinical trials.
- Lead internal technology transfer to the manufacturing facility by collaborating with cross-functional teams, e.g., PD, QA, SC, and QC, etc.
- Develop and review SOPs, MFG batch records.
- Serve as the primary manufacturing subject matter expert to ensure successful cGMP manufacturing, drive manufacturing decision-making, and track manufacturing KPI.
- Manage and maintain the routine operation of the cGMP manufacturing facility including the equipment.
- Collaborate with cross functional teams to support regulatory submission, address regulatory inquiries as well as regulatory/client virtual and in person audit
- BS degree in Pharmaceutical Sciences, Biomedical Engineering, Pharmaceutics, or related field with a minimum of ten (10) years OR MS degree with a minimum of eight (8) years OR PhD with a minimum of five (5) year of relevant proven manufacturing experience.
- Proven record and hands-on experience in cell therapy production and manufacturing management.
- Hands-on experience with closed and/or automation equipment used for cell therapy manufacturing: G-Rex, Prodigy, LOVO, Rotea, M1, and/or CRF, etc.
- Proficient in aseptic operation skill sets as well as cell culture operation.
- Experience in handling virtual and/or in person audit as well as support regulatory submission.
- Deep understanding and knowledge of cGMP requirements and proven experience in GMP operations.
- Ability to think critically, analytically and have demonstrated troubleshooting and problem-solving skills based on deductive reasoning.
- Highly organized, able to work in a fast-moving environment and prioritize work to achieve goals.
- Strong verbal and written communication skills, including technical writing.
