Manufacturing Associate I, Downstream Processing
Job Summary - a concise overview of the job
The Manufacturing Associate I, 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 is responsible for supporting necessary purification and production 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.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
§ Performs daily purification steps for cGMP manufacture of CCH BDS.
§ Works in hands-on capacity to operate chromatography systems, ÄKTA chromatography controllers, UF/DF skids, perform sterile filtrations, prepare production buffers, and clean equipment as required.
§ Ensures work is completed in compliance with approved SOP’s, batch records, controlled documentation, and all applicable regulations, guidelines, safety policies and procedures are followed.
§ Assists with process, equipment, and cleaning validation initiatives.
§ Assists in the resolution of manufacturing deviations/non-conformances.
§ Under direct supervision, assists with troubleshooting processes and equipment.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ HS Degree is required with a minimum of 0 to 3 years working in a pharmaceutical/biopharmaceutical cGMP manufacturing environment.
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ General knowledge of cGMP practices, ICH guideline and validation practices.
§ General knowledge of equipment cleaning practices and purification methods for biopharmaceutical products.
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.
§ Ability to work well with others and establish 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.
§ Standing for long periods of time.
§ Ability to wear a sterile gown and don shoe covers on a daily basis.
§ Ability to lift 40 pounds.