Position Summary
The Specialist, Manufacturing Technical Development is responsible for successful implementation of the site Manufacturing Training Program, developing/administering training solutions, training staff, and assessing proficiency. May perform cleanroom processing duties as needed.
Required Qualifications
- Bachelorβs degree in Biology, Biochemistry, Chemical, or Biomedical Engineering (or related) with 4β5+ 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/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.
Responsibilities
- 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.
Benefits (explicit)
- Health coverage; wellbeing support; 401(k); disability and life insurance.
- Paid time off (includes flexible time off/paid vacation and holidays, per eligibility).
Compensation
$38.12β$46.20/hour (Summit West β NJ β US).