Type: 6 month contract to start

Pay: $28 - $31 per hour

Location: South Philadelphia, PA (19112)

Shift Schedule: Rotating shifts, typically consisting of 3 days of 12-hour shifts one week, followed by 4 days of 10-hour shifts the following week.

As this person will be a key member of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations is required.

Specific Responsibilities

• Develop a comprehensive understanding of and be able to proficiently execute current cell therapy manufacturing process.
• 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 technical 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 the daily lab meeting and escalates issues/concerns at that forum to Area Management for further investigation.
• Ability to work in a team environment and independently as required. Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Other duties as assigned.

Qualifications

• 0-5 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 build relationships quickly and credibly.
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• Proactive, results oriented, self-starter with experience in a complex manufacturing environment.
• Ability to work successfully in a fast-paced team-oriented environment.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.