The Manufacturing Associate II, Upstream Processing works in a hands-on capacity in the cGMP fermentation and production support areas to manufacture collagenase clostridium histolyticum bulk drug substance (CCH BDS). This role authors and revises manufacturing and process equipment documentation and is responsible for supporting necessary fermentation and production activities, including validation and development work as needed.
Job Description
Scope of Authority
Fermentation and related manufacturing operations for the Horsham, PA site.
Key Accountabilities
Manufacturing & Compliance
Performs daily fermentation steps of cGMP manufacture of CCH BDS.
Works in a hands-on capacity to operate fermenters, perform seed scale-up, sterilize equipment, prepare media solutions, and clean equipment as required.
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.
Assists with process, equipment, and cleaning validation initiatives.
Assists in leading manufacturing activity as needed.
Documentation
Authors and revises manufacturing and process equipment documentation.
Investigation
Assists in the resolution of manufacturing deviations/non-conformances.
Under general supervision, assists with troubleshooting processes and equipment.
Qualifications
Education & Experience
High school diploma is required with a minimum of 2+ years working in a pharmaceutical/biopharmaceutical cGMP manufacturing environment, OR
BS degree with 1+ years’ relevant experience noted above.
Experience working with fermenters/bioreactors, holding tanks, aseptic operations, seed scale-up, CIP and SIP of process equipment is preferred.
Knowledge
Working knowledge of cGMP practices, ICH guidelines, and validation practices.
Working knowledge of fermenters, holding tanks, aseptic operations, seed scale-up, and cleaning and sterilization procedures for biopharmaceutical products.
Skills & Abilities
Demonstrated ability to troubleshoot and resolve equipment and processing issues.
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.
Self-starter, shows willingness to learn and problem-solve.
Has technical aptitude to learn and operate production equipment.
Physical Requirements
Ability to work in a clean room environment.
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.
