Pharmaceutical Manufacturing Specialist
Proclinical is currently recruiting for a Pharmaceutical Manufacturing Specialist with a pharmaceutical company located in Philadelphia, PA.
- Complete training sessions and ensure training documentation is maintained.
- Understands and complies with quality standards and requirements as documented.
- Provides operational support functions including materials stocking, kit preparation, reagent preparation, cleaning activities, and equipment maintenance.
- Supports tech transfer and additional research level testing activities.
- Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
- Support documentation needs, which may including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
- Attends lab meetings and escalates issues/concerns
- Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
Skills and Requirements:
- Minimum B.S. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
- Minimum of 2-3 years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
- Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
- Ability to mentor and provide best practices to other members of the team.
- Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
- Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
- Aseptic Manufacturing Technicians are required to work their assigned schedule. This position is currently for regular work week hours (1st shift M-F); however, due to the nature of cell therapy manufacturing schedules, must be willing to work alternative shifts, weekends, evenings, and holidays, as needed. It is also expected that regular work weeks may change once commercial manufacturing commences and may involve shift changes (i.e. Tuesday to Saturday). May be required to work overtime.
- Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).
- Must be able to work in Lab setting with Biohazards /various Chemicals
- Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors.
- Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards and strong odors.
- Ability to stand/sit/walk for long periods of time
- Ability to crouch, bend, twist, reach, and perform activities with repetitive motions
- Ability to lift 20 lbs
If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at 617-830-7546.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.