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Aseptic Manufacturing Technician

2 months ago

Philadelphia, United States Planet Pharma Full time

Titles: Aseptic Manufacturing Technician II/III/Sr./Leads

Shifts: 1st, 2nd, & 3rd shift openings (Sunday to Wednesday or Wednesday to Saturday schedule)

Type: 6 month contract to hire

Pay: $31 to $40 per (depending on years of experience)


Specific Responsibilities

  • Develop a comprehensive understanding of and be able to proficiently execute Iovance’s 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

  • Minimum B.S. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
  • 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.
  • Must adhere to Iovance Biotherapeutics core values, policies, procedures and business ethics.
  • Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).
  • May require up to 5% travel, based on business need.

Physical Requirements

  • Must be able to work in environment with variable noise levels
  • 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.
  • Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
  • 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