Supervisor, Upstream Processing
Description
Job Summary - a concise overview of the job | |||
The Supervisor, Upstream Processing supervises fermentation and production support activities for the development, validation, and cGMP manufacture of collagenase clostridium histolyticum bulk drug substance (CCH BDS). This hands-on supervisory position requires adhering to production schedules and shift-work within Manufacturing to meet overall department and company timelines.
All incumbents are responsible for following applicable Division & Company policies and procedures. | |||
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc. | |||
Responsible for the fermentation and production support activities for the Horsham, PA site. | |||
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Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time | |||
Accountability | Responsibilities | % of Time | |
Manufacturing / API Supply | § Supervises fermentation processes for commercial and clinical API production. § Supervises team in hands-on capacity during GMP operations and assists with daily production scheduling activities. § Provides timely technical input to support on-going operations and resolve manufacturing deviations/non-conformances. § Troubleshoots processes and equipment within the GMP facility and performs documentation closeout activities to release processes and equipment for production as required. § Supervises fermentation process scale-up or development activities as needed. | 60% | |
Validation & Continuous Improvement | § Works with Validation and leads process, equipment, and cleaning validation initiatives within the GMP facility. § Leads development, validation, and process improvement efforts and authors/implements change controls associated with fermentation and supporting equipment, processes, and utilities. § Identifies and supports continuous improvement initiatives. | 15% | |
Technical Documentation | § Authors, revises, and reviews manufacturing, equipment, facility and utility documentation, including but not limited to: SOPs, forms, master batch records, protocols, and reports. | 10% | |
Training | § Trains, coaches, and mentors Process Engineers and Manufacturing Associates. § Participates in cross-training initiatives, as appropriate. § Oversees and adjusts training programs within the team, ensuring that direct reports are current on training requirements. | 10% | |
Compliance | § Ensures manufacturing operations are established and maintained in compliance with all applicable regulations, guidelines and safety policies and procedures. § Assists QA, as required, with internal and external audits. | 5% | |
Total | 100% | ||
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Qualifications | |||
Education & Experience | Minimal acceptable level of education, work experience and certifications required for the job | ||
§ Bachelor’s degree in Biological Sciences or Bioengineering, or related field required; Master’s Degree, a plus. § Minimum 3+ years working in a biopharmaceutical cGMP manufacturing environment, technology development, technology transfer and validation, 5 years preferred. § Experience supervising, coaching, and/or mentoring junior level associates. § Strong background in fermentation processes and process scale-up. § Experience working with or in commercial and/or clinical manufacturing groups. | |||
Knowledge | Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. | ||
§ Knowledge of automated or semi-automated fermenters, bioreactors, clean-in-place systems, and harvest equipment. § Knowledge of cGMP and equipment, cleaning, and process validation practices for biopharmaceutical products. | |||
Skills & Abilities | Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc. | ||
§ Works well with others and establishes working relationships with Quality, Facilities/Engineering/Validation, Process Validation/Development, and Manufacturing. § Exhibits attention to detail, accuracy in work, and integrity of character. § Exhibits an open and constructive communication style based on the need of the receiver and by using the appropriate communication method. § Innovative and efficient when solving problems, considers possible implications of the decisions made. § Demonstrated ability to plan daily activities for self and team and resolve problems in area of expertise. § Ability to lead and develop a team in order to accomplish individual and corporate goals. § Promotes a culture of quality and safety in the manufacturing facility. | |||
Physical Requirements | Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc. | ||
§ Ability to stand for long periods of time. § Ability to wear a sterile gown and don shoe covers on a daily basis. § Ability to lift 40 pounds. | |||