Manufacturing Associate II, Downstream Processing
Job Summary - a concise overview of the job
The Manufacturing Associate II, 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 role authors and revises manufacturing & process documentation and is responsible for supporting necessary purification and production-related activities, including validation and development work as needed.
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.
Purification and related manufacturing operations for the Horsham, PA site
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
Manufacturing & Compliance
§ Performs daily purification steps for cGMP manufacture of CCH BDS.
§ Works in a hands-on capacity 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.
§ Assists with process, equipment, and cleaning validation initiatives.
§ Authors and revises manufacturing and process equipment documentation.
§ Assists in the resolution of manufacturing deviations/non-conformances.
§ Under general supervision, assists with troubleshooting processes and equipment.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ High school diploma is required with a minimum of 3-5 years working in a pharmaceutical/biopharmaceutical cGMP manufacturing environment OR
§ AS degree with 2-4 years’ relevant experience noted above OR
§ BS degree with 1-3 years’ relevant experience noted above.
§ Experience with CIP, chromatography systems, TFF skids, aseptic operations, integrity testers.
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Working knowledge of cGMP practices, ICH guidelines, and validation practices.
§ Working knowledge of equipment cleaning practices and protein purification methods (including chromatography and UF/DF) for biopharmaceutical products.
§ Has familiarity with the use of a database.
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 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 & 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.