Research Assistant Job at Planet Pharma, Philadelphia, PA

R1hzZG1WMkp5RjhmMDFXaHBrMDBOb2RFWHc9PQ==
  • Planet Pharma
  • Philadelphia, PA

Job Description

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.

Job Tags

Hourly pay, Contract work, Shift work, Rotating shift, Day shift,

Similar Jobs

Walong Marketing, Inc.

Warehouse Manager Job at Walong Marketing, Inc.

 ...receiving, storage, cycle counts, and replenishment, to ensure accurate stock levels and minimize discrepancies. Lead a team of warehouse supervisors, coordinators, and associates, providing guidance, training, and performance feedback to ensure a high-performing and... 

Heroic Performance

Personal Trainer Job at Heroic Performance

 ...businesses in LA, business development and operations positions will be available upon qualifications! In time, hopefully next year, salaried gym operations management will up for grabs with the addition of a facility to our portfolio! So truly, the opportunities are endless!... 

Ozaukee County

Equipment Operator - Highway Department - Port Washington Job at Ozaukee County

 ...beam guards/cable guards, ditching, repairs gravel shoulders, removes/cuts trees, and maintains/repairs concrete and asphalt roads and bridges. Highway Construction: Operates asphalt plant, asphalt road paving, operates gravel pit with crushing equipment, replaces... 

Conrad Consulting

Structural Revit Technician Job at Conrad Consulting

Are you a talented Structural Revit Technician looking for your next career move? Our client are a leading consulting engineering firm in Orlando, offering exciting opportunities to work on some of the most challenging and innovative projects in the industry. Their team...

Medisys Health Network, Inc.

Epic ASAP Analyst Job at Medisys Health Network, Inc.

 ..., reported on, resolved and/or escalated in a timely manner. Desired Skills & Experience JOB REQUIREMENTS: Experience with Epic ASAP application is strongly preferred, ASAP certification a plus. Outstanding communication, collaboration and facilitation skills...