Manufacturing Associate II, Downstream Processing

Facilities Horsham, Pennsylvania


Description

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

Accountability

Responsibilities

% 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.

80%

§  Assists with process, equipment, and cleaning validation initiatives.

10%

Documentation

§  Authors and revises manufacturing and process equipment documentation.

5%

Investigation

§  Assists in the resolution of manufacturing deviations/non-conformances.

§  Under general supervision, assists with troubleshooting processes and equipment.

5%

Total

100%

 

Qualifications

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.




Knowledge

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.

Skills

&

Abilities

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 Requirements

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.