Manufacturing Associate lI, 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.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.