Manufacturing Lead, Upstream Processing

Manufacturing & Packaging Horsham, Pennsylvania


Description

Job Summary - a concise overview of the job

The Manufacturing Lead, Upstream Processing works in a hands-on capacity in the cGMP fermentation and production support areas to manufacture and support the equipment and process used to manufacture collagenase clostridium histolyticum bulk drug substance (CCH BDS). This technical position is responsible for leading development, validation, process improvement initiatives, and production activities to meet department and site timelines/objectives. This role is expected to be a technical expert in the fermentation area.

 

 

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.

Fermentation and related manufacturing operations at the Horsham, PA site; works closely within the Manufacturing department and collaborates with Manufacturing Technology, Quality Control, Quality Assurance, Validation, Regulatory Affairs, Warehouse Operations, and Planning & Materials Management.

 

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

Accountability

Responsibilities

% of Time

 

Manufacturing & Compliance

§  Performs and supports fermentation processes for commercial and clinical API production.

§  Leads manufacturing production activities to operate fermenters, perform seed scale-up, sterilize equipment, prepare media solutions, and clean equipment.

§  Ensures work is completed in compliance with approved SOPs, batch records and controlled documentation and all applicable regulations, guidelines, safety policies and procedures are followed.

§  Provides timely technical input to support ongoing operations.

60%

Validation & Continuous Improvement

§  Works with cross-functional teams 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.

10%

Technical Documentation

§  Authors, revises and reviews manufacturing and process equipment documentation.

10%

Investigation

§  Authors investigation documentation and participates in/resolves manufacturing deviations/non-conformances.

§  Troubleshoots processes and equipment and leads process, sterilization, and cleaning validation initiatives.

10%


Training

§  Acts as qualified trainer for SOPs and procedures in functional area.

§  Trains Manufacturing Associates of all levels as appropriate.

§  Participates in cross-training initiatives as appropriate.

10%

Total

100%

 

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and  certifications required for the job

§  High school diploma is required with a minimum of 7+ years working in a pharmaceutical/biopharmaceutical cGMP manufacturing environment, technology development, technology transfer and/or validation, OR

§  AS degree with 6-8 years’ relevant experience noted above OR

§  BS degree in Biological Sciences or Bioengineering with 5-7 years’ relevant experience, preferred.

§  Experience working with or in commercial and/or clinical manufacturing groups.

§  Strong background in fermentation and process scale-up of proteins and enzymes required.


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.

§  Advanced knowledge of cGMP practices, ICH guidelines, validation practices.

§  Technical expert in fermentation/upstream processing.

§  Advanced knowledge of automated or semi-automated fermenters, bioreactors, holding tanks, aseptic operations, seed scale-up, harvest equipment, and cleaning and sterilization procedures for biopharmaceutical products.

§  Advanced knowledge of process validation practices for biopharmaceutical products and can author and lead process validation protocols and efforts.

§  Strong knowledge of use of a database and basic understanding of statistical methods.

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.

§  Demonstrated ability to resolve equipment and process problems and to plan daily activities for self and resolve problems in area of expertise.

§  Works well with others and establishes working relationships with Quality, Facilities/Engineering/Validation, Process Validation/Development, and Manufacturing Validation/Development, and Manufacturing.

§  Exhibits attention to detail and accuracy in work, and integrity of character.

§  Self-starter, shows willingness to learn and problem-solve.

§  Demonstrated ability to plan daily activities for self and resolve problems in area of expertise.

§  Innovative and efficient when solving problems; considers possible implications of the decisions made.

§  Ability to teach, lead and mentor co-workers.

§  Demonstrated ability to troubleshoot and resolve equipment and processing issues.

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.