Manager, Manufacturing: Cell Culture, Cell Bank And Vaccine
Charles River Laboratories (Philadelphia, Pennsylvania)

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BASIC SUMMARY: 

Provide operational management, technical support and professional and scientific expertise to the manufacturing department that includes cell culture, mammalian and microbial cell banking and vaccine laboratories.

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

·         Manage daily manufacturing vaccine, cell culture and cell bank laboratory activities and scheduling. Assist in preparing monthly/Weekly manufacturing and related testing schedules. Oversee raw material and cell bank inventory. Identify manufacturing and related testing issues and propose solutions. Perform investigations and root cause analysis as required.

·         Coordinate activities to ensure validation/revalidation, preventive maintenance programs, training, maintenance and safety programs are met. Meet predefined metrics related to manufacturing and related testing and facility operation.

·         Ensure technicians/operators are qualified and trained. Train technical personnel in general laboratory skills; reinforce regulatory concepts (cGMP) and specific laboratory techniques.

·         Perform technical troubleshooting

·         Provide guidance to Customer Service department handling customer relations. 

·         Ensure that facility, equipment and processes are validated and operations are in compliance with cGMP. Participate in validation of equipment and facility and review and approval of validation reports. Identify and resolve any issues related manufacturing and testing processes/systems including quality and compliance that require remedial actions. Maintain and revise as necessary documentation related manufacture of vaccine, cell culture and cell bank including BPS, SOPs, etc. Meet with relevant QA department personnel to coordinate documentation reviews and audits. Maintain high level of security to assure document integrity.

·         Manage activities of assigned group(s) to ensure effective performance of function.

·         Interview and select qualified exempt- and non-exempt level departmental personnel.  Recommend, review and approve personnel actions, including hiring, promotions and raises.  Partner with Human Resources in the handling of disciplinary issues.  Prepare and/or approve appropriate personnel action paperwork. 

·         Identify training and development needs of direct reports.  Develop and oversee the implementation of departmental training programs, including orientation; monitor training programs to ensure ongoing effectiveness.

·         Monitor performance of direct reports.  Provide regular coaching and counseling.  Prepare and deliver salary and performance reviews; review and approve performance and salary appraisals initiated by direct reports.

·         Authorize overtime as needed.  Review and approve time cards.  Review and approve vacation/time off requests and coordinate vacation/time off schedules.

·         Assist in the development of short- and long-range operating objectives, organizational structure, and staffing requirements.

·         Assist in the development and recommendation of departmental budget.  Authorize expenditures in accordance with budget.  Approve budget and expenses of subordinates.

·         Ensure optimum performance of group function.  Determine and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices.

·         Develop and maintain departmental systems and SOPs.  Assist in the development and communication of departmental policies and procedures.  Partner with Human Resources to develop and approve job descriptions for subordinate positions; ensure communication of duties and responsibilities to employees.

·         Perform all other related duties as assigned.

QUALIFICATIONS:

o       Education:  Four year Bachelor’s degree (B.S./B.A.) or post graduate degree or equivalent in biology, chemical engineering or a related discipline.

·        Experience:  Minimum of 5 -10 years previous experience in a relevant position in GMP manufacturing in a Biopharmaceutical company. Experience in mammalian cell culture and bacterial fermentation, filtration, formulation and aseptic filling.

·         An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

·         Certification/Licensure:  None.

·        Other: Demonstrated supervisory and leadership skills required. Working knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biotechnology industries required. Excellent technical writing and computer skills. Ability to produce to deadlines, interact with many people and manage competing priorities.