Bioprocess Technician Ii - East Norriton, United States - Resilience

Resilience
Resilience
Verified Company
East Norriton, United States

3 weeks ago

Mark Lane

Posted by:

Mark Lane

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Description
A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made.

We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit

  • Position Summary & Role
  • The Technician II, Cell Therapy Manufacturing position is responsible for the handson clinical manufacturing of cell therapy product according to current Good Manufacturing Practices (cGMPs) and procedures. The position will work directly with a team of manufacturing technicians, specialists and scientists in Cell Therapy Manufacturing and Process Development and report to the Bioprocess and Cell Therapy Supervisor.
  • Job Responsibilities
  • Participates in the handson manufacture of cell therapy products, using stateoftheart cell manufacturing technologies (i.e., CliniMACS Prodigy, Xuri Bioreactor, Finia Fill and Finish System, etc.), media preparation, cell culture maintenance, sampling and cell counting (i.e., NC200 and MultiSizer).
  • Follows and executes batch records and standard operation procedures.
  • Performs aseptic and closed manipulations within Biosafety Cabinet and Grade B, C and D Cleanrooms.
  • Performs manufacturing process steps in accordance with cGMP, procedures and relevant regulations.
  • Performs delegated work assignments in a timely and complete manner.
  • Supports Process Development and Manufacturing Sciences, as needed.
  • Authors and maintains controlled documents including but not limited to SOPs, forms and batch records.
  • Assists with deviation investigations and implementing CAPAs.
  • Assists with qualification and validation activities including equipment qualification, gown qualification, aseptic process validation and process qualification/validation.
  • Maintains manufacturing facility in a 5S and inspectionready state.
  • Cross trains in other areas including Vector Manufacturing to perform additional job functions, as necessary.
  • Physical Responsibilities
  • Must be able to work in setting with Biohazards and various Chemicals.
  • Must be able to wear appropriate clean room attire (i.e., surgical masks) and all Personal Protective Equipment (PPE).
  • Must be able to work in environment with variable noise levels.
  • Ability to stand, sit, and walk for long periods of time.
  • Ability to lift, push and pull 40 lbs. routinely.
  • Ability to crouch, bend, twist, and reach.
  • Clarity of vision at near and midranges (less than 20 feet), depth perception and ability to identify and distinguish colors.
  • Must be able to perform activities with repetitive motions.
  • Ability to climb ladders and stairs.
  • Minimum Qualifications
  • Strong organization skills with the ability to present results clearly and logically, working collaboratively as part of a team as well as independently.
  • Experience working in GMP/ pharmaceutical manufacturing
  • Good attention to detail and ability to follow written procedures.
  • Demonstrated ability to work in a dynamic, fastpaced team environment and to meet timelines.
  • Preferred Qualifications
  • Associates/Bachelor's (science preferred) degree with 13 years of relevant or equivalent experience.
  • Other Ideal Personal Characteristics:
  • Reliable
  • Adaptable
  • Willingness to learn
  • Will occasionally require weekend, late evening, and overtime work to support scheduled and unscheduled cell therapy manufacturing operations.
Resilience is an Equal Employment Opportunity Employer.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws.

Requests for reasonable accommodation can be made at any stage of the recruitment process.

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