Specialist, Manufacturing Technical Development

Position Summary

The Specialist, Manufacturing Technical Development is responsible for successful implementation of the site Manufacturing Training Program, developing and administering training solutions, training staff, and assessing proficiency. May perform cleanroom processing duties as needed.

• Bachelor’s degree in Biology, Biochemistry, Chemical, or Biomedical Engineering (or related) with 4–5+ years in a clinical laboratory or blood/cell culture processing environment.
• Strong understanding of cell therapy processes, controls, and GMP requirements.
• Intermediate skills designing, developing, and implementing training.
• Advanced proficiency in MS Word, PowerPoint, and Excel.
• Strong organizational/time management; clear communicator (classroom); strong interpersonal/collaboration skills.
• Ability to work in an aseptic environment, including successful completion of a qualification program.

• Collaborate with Manager to create training plans; implement training goals and meet KPIs.
• Conduct ILT/OJT; provide trainee feedback; solicit trainee feedback for continuous improvement.
• Ensure training compliance/effectiveness; maintain training documentation and records.
• Develop course content/procedures (SOPs/TRNs) and update as procedures/techniques change.
• Conduct competency assessments; support new-hire onboarding (schedules, admin tasks, ILT/OJT, systems access, status updates).
• Maintain Training Lab cleanliness/compliance; logs, calibration checks, supplies.
• As needed: execute batch records in ISO 7/8, support GMP/GDP, aseptic/sterile gowning qualifications, sample handoffs, quality/safety reporting, nonconformances.

• Health coverage; wellbeing support; 401(k); disability and life insurance.
• Paid time off (includes flexible time off/paid vacation and holidays, per eligibility).

$38.12–$46.20/hour (Summit West – NJ – US).