Genezenlabs
Manufacturing Technician I - Buffer Prep (M-F, 7am-3:30pm)
Lexington, MA. Posted 3 months ago
The role
The Manufacturing Technician I performs routine and non-routine manufacturing operations in a cGMP environment. This includes process execution, in-process controls, equipment operation, and documentation for cell and gene therapy products.
What you will do
- Execute routine and non-routine production activities according to the manufacturing schedule.
- Follow cGMP requirements, SOPs, batch records, and solution preparation records.
- Use the Enterprise Resource Planning (ERP) system to execute transactions.
- Demonstrate and apply aseptic processing techniques.
- Operate in production areas including Pre-culture, USP, DSP, buffer preparation, and Fill Finish.
- Perform troubleshooting activities within established procedures.
- Participate in shift handoffs and communicate critical production information.
- Complete manufacturing documentation following GDP principles.
- Review batch records, solution records, logbooks, and forms.
- Perform routine equipment cleaning and standardization activities.
Required qualifications
- High School, Associates, or Bachelor's Degree
- 0-2 years prior manufacturing experience
- Hands-on experience in writing and reviewing documentation
- Experience in (bio)-manufacturing unit operations (USP and/or DSP)
- Excellent written, verbal, and interpersonal communication skills
- Working knowledge of and adherence to SOPs, Good Documentation Practices (GDP), and applicable regulatory requirements
- Ability to lift up to 40 lbs
Nice to have
- Degree preferably in Life Sciences/Engineering field
- Experience preferably in a comparable position
- Experience preferentially in an industrial organization
Benefits
- Paid vacation days, amount based on tenure
- Paid sick time
- 10 observed holidays + 2 floating holiday + 1 volunteer day
- 401(k) plan with company match up to 6% of salary
- Share Appreciation Rights
- Choice of several healthcare plans
- FSA and HSA programs
- Dental and vision care
- Employer-paid basic term life/personal accident insurance
- Voluntary disability, universal life/personal accident insurance
- Accidental Death & Dismemberment (AD&D) Insurance
Before you apply
- Criminal background check required
- Not able to sponsor visas
About the company
Genezen provides process development, produces GMP viral vectors, and provides cell transduction for gene and cell therapy clinical trials.