Manufacturing Associate II, Manufacturing Support Services

Manufacturing & Packaging Horsham, Pennsylvania


Description

Job Summary - a concise overview of the job

The Manufacturing Associate II, Manufacturing Support Services works in a hands-on capacity in the cGMP production support areas (buffer preparation, equipment cleaning, etc.) to support manufacture of collagenase clostridium histolyticum bulk drug substance (CCH BDS). This role is responsible for the inventory, preparation, and storage of equipment and supplies related to cGMP production and authors and revises SOPs and forms applicable to manufacturing and process equipment documentation.This role supports necessary production and production-related activities, including validation and development work as needed and assists in training new hires and junior team members on production support activities and procedures. 

 

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.

Production 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 weigh/dispense, buffer preparation, and other process support operations for cGMP manufacture of CCH BDS.

§  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.

§  Enters/updates data into compliance documents and computer applications.

§  Responsible for the inventory, preparation, and storage of equipment and supplies related to cGMP production.

§  Assembles, cleans, and sterilizes production equipment using glassware washers, autoclaves, and CIP technologies.

§  Assists with and executes process, equipment, and cleaning validation protocols.

85%

Investigation

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

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

5%

Documentation

§  Authors and revises SOPs and forms applicable to manufacturing and process equipment documentation. 

§  Documents work as per SOPs in logbooks, forms, and batch records.

5%

Training

§  Assists in training new hires and junior team members on production support activities and procedures.

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 commercial or late-stage clinical 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, glassware washers, autoclaves, buffer/media preparation, filtration, integrity testers, and aseptic operations.


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 cGMP and equipment cleaning and sterilization practices for biopharmaceutical products.

§  General understanding of chromatographic and UF/DF principles.

§  Has familiarity with the use of databases.

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.

§  Follows schedules and work plans, and coordinates with the Manufacturing group to provide timely support functions.

§  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 a strong sense of integrity.

§  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 shoe covers on a daily basis.

§  Ability to lift 40 pounds.