Supervisor, Downstream Processing

Manufacturing & Packaging Horsham, Pennsylvania


Description

Job Summary - a concise overview of the job

The Supervisor, Downstream Processing supervises purification 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 coordinating weekly and daily 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 purification and production support activities for the Horsham, PA site.

 

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Manufacturing / API Supply

§  Supervises purification processes for commercial and clinical API production.

§  Supervises team in hands-on capacity during cGMP 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 as required and performs documentation closeout activities to release processes and equipment for production as required.

§  Supervises purification process scale-up or development activities as needed.

§  Authors, revises, and reviews manufacturing, equipment, facility and utility documentation, including but not limited to: SOPs, forms, master batch records, protocols, and reports.

75%

Validation & Continuous Improvement

§  Works with Validation and leads process, equipment, and cleaning validation initiatives within the GMP facility.

§  Leads equipment & system validation and cleaning efforts and authors/implements change controls associated with purification and support equipment, processes, and utilities.

§  Identifies and supports continuous improvement initiatives.

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%

 

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; Master’s Degree, a plus.

§  Minimum 6+ years working in a biopharmaceutical cGMP manufacturing environment, technology development, technology transfer and validation.

§  Experience supervising, coaching, and/or mentoring junior level associates.

§  Strong background in protein purification 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 chromatography and filtration systems required.

§  Working 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.