Manufacturing Associate l DSP
Job Summary - a concise overview of the job
The Manufacturing Associate I – Fermentation works in a hands-on capacity in the cGMP fermentation and production support areas to manufacture Collagenase Clostridium Histolyticum (CCH) bulk drug substance (BDS). This role is responsible for supporting necessary fermentation 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.
Fermentation and related manufacturing operations.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
Manufacturing and Compliance
§ Performs daily fermentation steps of cGMP manufacture of CCH BDS:
o Work in hands-on capacity to operate fermenters, perform seed scale-up, sterilize equipment, prepare media solutions, and clean equipment as required.
o Ensures all work is completed in compliance with approved SOPs, batch records, controlled documentation, and that 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.
§ Assists with troubleshooting processes and equipment.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ Minimum 0-3 years working in biopharmaceutical cGMP manufacturing environment, or equivalence in relevant experience.
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 and equipment cleaning practices 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 across functional departments - 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.