Job Description
Description - Perform and document routine testing duties including: GMP potency testing of drug substance and drug product samples for product release and stability; potency comparability and non-GMP studies; testing of manufacturing growth medium components for raw material release; testing by qPCR (for Minute Virus of Mouse), ELISA (for identity, residual host cell protein, residual DNA and residual protein A), cIEF (for identity) Biacore (for identity and binding), SDS-PAGE and Western (for identity and purity).
- May assist in assay development and optimization activities
- Assist with critical reagent and method qualifications, method validation/transfer, lab investigations and assay troubleshooting.
- Operate and maintain QC laboratory equipment and instruments in a cGMP-compliant manner.
- Work through obstacles; perform and complete routine assignments according to written procedures with supervision.
- Perform laboratory duties and safety checks following all safety, GMP, CFR and other regulations in order to assure laboratory compliance.
- Evaluate laboratory SOPs and recommends improvement opportunities to maintain compliance with corporate and regulatory guidelines.
- Revise laboratory SOPs and Work Instructions as assigned.
- May participate in the on-call response team for chamber excursions, train as a Self-Inspector Auditor and participates in department Self Inspections and assist with reference standard fill.
Qualifications - Experience with running ASSAYs in the laboratory
- Flexibility
- Entry level role with 0 to 1 years' experience
- Experience with PCR
- GMP working in the Laboratory
Benefits Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.
Job Tags
Full time,