Biologist
Synectics Inc. · Worcester, MA · 1 wk ago
ScienceContract
About the role
As part of the PDS&T Biologics organization, MSAT leads the process technology transfer, optimization, validation, implementation, and continuous process improvement for late-stage and commercial manufacturing of therapeutic proteins. You will provide technical support for manufacturing, GMP compliance, and regulatory filing, and drive and implement improvement of processes and technologies for commercial products to deliver quality, compliance, financial, and innovation goals.
Responsibilities
- Provide technical support to late clinical stage and commercial biologics manufacturing processes.
- Support lab scale studies relevant to late clinical stage and commercial biologics manufacturing processes.
- Support the writing and data review of official documentation relevant to late clinical stage and commercial biologics manufacturing processes.
- Perform data monitoring and trending for continuous process verification.
- Apply GMP and GLP principles to all aspects of work and documentation.
Qualifications
- BS/MS degree in a scientific or engineering discipline with 0-2 years of related industry experience.
- Knowledge of applicable regulatory authority, compendia, and ICH guidelines.
- Ability to understand and independently apply GMPs and/or GLPs to everyday work with regard to documentation and instrument use.
- Proficiency in Microsoft Excel and Word to perform tasks.
- Good written and oral communication skills.
- Time management and project management skills.
- Problem-solving and troubleshooting abilities.
- Ability to work in a collaborative team environment.
- Strong organization skills with high attention to detail.
- Aseptic handling experience (desirable).
- Coding experience or advanced Excel capabilities (desirable).
- Demonstrated problem-solving skills and capability to overcome complex issues.
- Results-oriented work ethic with a positive "can-do" attitude, strong sense of urgency, and self-motivation.
Schedule
8 hours per day, 5 days a week, with weekend work as necessary.
Benefits
- Healthcare Insurance: Eligible employees and dependents receive coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment. Premiums are subsidized by Synectics.
- Dental Insurance: Eligible employees and dependents receive coverage through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment.
- Vision Insurance: Eligible employees receive coverage through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment.
- 401(k) Plan: Employees aged 21 or older may invest in the Synectics Inc. Investment Savings Retirement Plan on the first of the month following at least one calendar year of employment.