Horsham, PA, USA
The Manufacturing Lead, Downstream Processing works in a hands-on capacity in the cGMP purification and production support areas 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 purification area.
Scope of Authority – Purification and related manufacturing operations for 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.
Manufacturing & Compliance = 65%
- Performs and supports purification process scale-up, cGMP manufacture and validation activities.
- Leads manufacturing production activities to operate chromatography systems, ÄKTA chromatography controllers, UF/DF skids, perform sterile filtrations, prepare production buffers, 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.
Validation & Continuous Improvement = 15%
- Works with cross-functional teams and leads process, equipment and cleaning validation initiatives within the GMP facility.
- Leads validation efforts and authors change controls associated with purification equipment, processes, and utilities.
- Identifies and supports continuous improvement initiatives.
Technical Documentation = 10%
- Authors, revises and reviews manufacturing and process equipment documentation.
Investigation = 5%
- Authors investigation documentation and participates in/resolves manufacturing deviations/non-conformances.
- Troubleshoots processes and equipment and leads process and cleaning validation protocol execution.
Training = 5%
- 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.
Education & Experience
- High school diploma is required with a minimum of 7+ years working in a pharmaceutical/biopharmaceutical cGMP manufacturing environment, technology development, technology transfer, 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,
- Experience working with or in commercial and/or clinical manufacturing groups.
- Experience with CIP, chromatography systems, TFF skids, aseptic operations, integrity testers.
- Strong background in purification and process scale-up of proteins and enzymes is required.
- Advanced knowledge of cGMP practices, ICH guidelines, and validation practices.
- Technical expert in purification/upstream processing.
- Advanced knowledge of equipment cleaning practices and protein purification methods (including chromatography and UF/DF) 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
- 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.
- 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.
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