ProBio-Manufacturing Supervisor

Job Scope:

GenScript ProBio, USA is seeking a Manufacturing Supervisor. The incumbent shall report to the Manufacturing Manager and shall primarily be responsible for leading a manufacturing team in the upstream and downstream processing of plasmid DNA or viral vector products per client projects. These products shall be suitable for use in the manufacturing of a wide range of clinical or commercial materials for cell and gene therapy treatments. 
This is a full-time position with regular 1st shift attendance (current). The position may move to 2nd shift after site launch in mid to late 2024. Occasional weekend work may also be required. Operation will be out of a new GMP manufacturing facility located in East Hanover, NJ. 
The Manufacturing Supervisor is a key member of the Manufacturing Team, working both independently and in a team to contribute to the qualification, operation, and overall success of the manufacturing facility. The Manufacturing Supervisor shall be accountable for providing direct oversight, coaching, and mentorship in the manufacturing of the biologics products, as well as coordinating activities within the production facilities to support the manufacturing operations in accordance with cGMPs. 

Roles and Responsibilities: 

1.    Supervise the production of GMP batches according to the plasmid DNA and/or mRNA product manufacturing process flows.
2.    Oversee the hiring, training, development, retention, and performance of the manufacturing personnel to align with site and corporate employee training and development policies.
3.    Ensure effective resource planning and utilization through performance management, employee development, and succession planning.
4.    Maintain the personnel schedule, making adjustments where necessary to ensure adequate staffing per process needs in order to deliver on the daily production schedule.
5.    Supervise all MFG-related process training, including development and execution of appropriate personnel training matrix aligned with routine MFG activities to maintain fast-paced production needs. The incumbent shall ensure all training for all manufacturing personnel is complete and up-to-date.
6.    Must be hands-on and work side-by-side with cross-functional teams to develop and standardize the cGMP process(es) to meet all related regulatory requirements. 
7.    Investigate deviations/non-conformances while providing necessary measures to minimize MFG errors and improve Quality of batch output.
8.    Maintain the manufacturing areas in a constant state of inspection-readiness, including full compliance with SOPs and regulatory guidelines.
9.    Promote safe work habits by adhering to GenScript ProBio USA safety procedures and guidelines.
10.   Author, review, approve, and/or execute SOPs, production batch records, training materials, protocols, deviations, CAPAs, and other manufacturing documentation as required.
11.   Maintain a high level of knowledge in gene and cell therapy with sensitivity in the field of T-Cell (CAR-T, TCR) and other novel products developed.
12.   Serve as a SME on all applicable manufacturing processes and equipment, participating in audits/inspections as needed.
13.   Interface with both internal and external clients to ensure a functional GMP environment for CDMO needs.
14.   Execute other duties and tasks as assigned based on business needs.

Position Information: 

Work Location: Piscataway, NJ/East Hanover, NJ

Work Shift: Full-time, regular, 1st shift (current); Potentially move to 2nd shift after site launch in 2024

Reports to: Manufacturing Manager

Qualifications:

1.    Bachelor’s degree in Pharmaceutical Chemistry, Chemical Engineering, Biology, Molecular Biology, Biochemistry, Bio-Molecular Engineering or equivalent.
2.    3-5 years in biotech manufacturing with specific experience in a gene and cell therapy cGMP production environment, with ability to manage and oversee development of GMP team and processes.
3.    1-2 years of direct management experience with a successful track record of building, coaching and mentoring a high-performing team, executing daily tasks to complete and deliver manufacturing batches.
4.    Experience with plasmid DNA, recombinant viral vectors, mRNA, or gene modified T-cell products is a plus.
5.    Experience with aseptic techniques and fill/finish Isolator. Must pass and maintain gowning qualification to enter clean room production environments.   
6.    Knowledge and hands-on experience in process development or “Scale-Up” of immune cell therapy technologies, gene editing and gene therapy technologies preferred
7.    Experience in GMP-scale production with clinical or commercial manufacturing requirements as well as familiarity with fermentation and purification equipment and systems preferred
8.    Experience with single-use 10L-300L bioreactor/fermenter is a plus.
9.    Ability to lift minimum of 40lbs unassisted. 
10.  Understand essentials and requirements of quality management systems (QMS) used in GMP productions.
11.   Ability to collaborate with all internal and external function groups and adapt the priority and timeline change.
12.   Experience in CMC regulatory affairs for FDA and EMA is a plus.
13.   Strong interpersonal, verbal, and written communication skills. 

Salary : $69,600 - $88,200