Cell Specialist I/II
Organogenesis
4 months ago
On-site
Canton, MA
Operations
What You Will Achieve:
- Monday–Friday, 7:30am–4:00pm; weekend work/coverage as needed.
- Participate and lead manufacture of HEP & HDF cell banks under direct supervision.
- Perform and manage cell production tasks (tissue dissociation, spinner preparation, seeding, maintenance, and harvest) in a Class 10,000 clean room.
- Support activities including production/expansion of cell banks, creation of test cells, senescence of Master Cell banks, and production of range finders and G100 range finders.
- Provide support to ongoing manufacturing operations requiring technical expertise in cell banking and cell culture.
How You Will Achieve It:
- Dissociate tissue and manufacture cell banks per established procedures.
- Maintain cell bank inventory in compliance with AATB, FDA, and state/local regulations.
- Follow cGMP, protocols/policies, regulatory requirements, and safety guidelines.
- Conduct batch record reviews; ensure documentation completeness/compliance.
- Coordinate with QC/Cell Culture for cell bank testing; review/transfer completed batch records to Quality Assurance.
- Operate equipment per procedures; maintain required records for QC/cGMP/safety.
- Assist with databases for trending and analysis of cell culture technical data.
- Provide technical/operational support and problem-solving.
- Coordinate corrective measures for audit deficiencies.
- Work in Class 100,000 and/or Class 10,000 clean room environments ensuring personal and product safety.
- Cell culture of mammalian cell banks (e.g., T-flasks, cell factories, spinner flasks) and cryopreservation.
- Keep manufacturing documents current and updated with high accuracy.
- Communicate effectively across departments; perform additional duties as assigned.
What You Need to Achieve It:
- Associate’s or Bachelor’s in biological sciences with 3+ years’ experience, or 5–7 years in biotechnology/related field.
- Aseptic technique experience; controlled clean room protocols.
- Strong manufacturing competence; knowledge of QC/QA and cGMP manufacture of cellular products.
- Equipment operation knowledge (e.g., incubators, controlled rate freezers, centrifuges, biosafety cabinets).
- Ability to comply with SOPs for cell banking and tissue processing suites.
- Organizational/documentation skills; problem solving; excellent communication.
- Leadership ability.
- Cell counting on a hemocytometer.
- Basic computer skills (Microsoft Word, Excel).
- Ability to work independently and in a team.
- Manual dexterity; ability to work in a clean-room environment for extended periods.
Benefits (as listed):
- 401(k) with immediate vesting and 100% match (when eligible).
- Medical, dental, vision effective on day one; FSA or HSA.
- Paid insurances (short/long term and life) plus voluntary options; paid maternity and parental leave; adoption benefits.
- Education Assistance: $5,000/year.
- Wellness program and Employee Assistance Program.
- Generous paid time off (vacation, floating holidays, sick days, company holidays).
- Free parking (electric charging available) and discounts.
Salary (stated):
- Level I: $55,000; Level II: $65,000 (anticipated annualized base salary).
- Monday–Friday, 7:30am–4:00pm; weekend work/coverage as needed.
- Participate and lead manufacture of HEP & HDF cell banks under direct supervision.
- Perform and manage cell production tasks (tissue dissociation, spinner preparation, seeding, maintenance, and harvest) in a Class 10,000 clean room.
- Support activities including production/expansion of cell banks, creation of test cells, senescence of Master Cell banks, and production of range finders and G100 range finders.
- Provide support to ongoing manufacturing operations requiring technical expertise in cell banking and cell culture.
How You Will Achieve It:
- Dissociate tissue and manufacture cell banks per established procedures.
- Maintain cell bank inventory in compliance with AATB, FDA, and state/local regulations.
- Follow cGMP, protocols/policies, regulatory requirements, and safety guidelines.
- Conduct batch record reviews; ensure documentation completeness/compliance.
- Coordinate with QC/Cell Culture for cell bank testing; review/transfer completed batch records to Quality Assurance.
- Operate equipment per procedures; maintain required records for QC/cGMP/safety.
- Assist with databases for trending and analysis of cell culture technical data.
- Provide technical/operational support and problem-solving.
- Coordinate corrective measures for audit deficiencies.
- Work in Class 100,000 and/or Class 10,000 clean room environments ensuring personal and product safety.
- Cell culture of mammalian cell banks (e.g., T-flasks, cell factories, spinner flasks) and cryopreservation.
- Keep manufacturing documents current and updated with high accuracy.
- Communicate effectively across departments; perform additional duties as assigned.
What You Need to Achieve It:
- Associate’s or Bachelor’s in biological sciences with 3+ years’ experience, or 5–7 years in biotechnology/related field.
- Aseptic technique experience; controlled clean room protocols.
- Strong manufacturing competence; knowledge of QC/QA and cGMP manufacture of cellular products.
- Equipment operation knowledge (e.g., incubators, controlled rate freezers, centrifuges, biosafety cabinets).
- Ability to comply with SOPs for cell banking and tissue processing suites.
- Organizational/documentation skills; problem solving; excellent communication.
- Leadership ability.
- Cell counting on a hemocytometer.
- Basic computer skills (Microsoft Word, Excel).
- Ability to work independently and in a team.
- Manual dexterity; ability to work in a clean-room environment for extended periods.
Benefits (as listed):
- 401(k) with immediate vesting and 100% match (when eligible).
- Medical, dental, vision effective on day one; FSA or HSA.
- Paid insurances (short/long term and life) plus voluntary options; paid maternity and parental leave; adoption benefits.
- Education Assistance: $5,000/year.
- Wellness program and Employee Assistance Program.
- Generous paid time off (vacation, floating holidays, sick days, company holidays).
- Free parking (electric charging available) and discounts.
Salary (stated):
- Level I: $55,000; Level II: $65,000 (anticipated annualized base salary).