Job Description
Description
- Responsible for support of programs that are preparing for commercial development.
- The team leads commercial method development, optimization, robustness, and validation.
- In collaboration with cross-functional partners, the team supports commercial formulation and process development studies.
- The team also leads tech transfer of final methods to commercial testing labs in Operations QC across the network.
- Key deliverables include: product control strategies informed by analytical data and method understanding; robust analytical methods suitable for commercial QC labs; comprehensive data packages that drive product and process understanding; clinical supplies release testing and stability studies to establish clinical product dating; substantial clinical trial application and marketing authorization submission content.
- Support method development, robustness, and validation studies.
- Additional laboratory testing to be assigned as appropriate.
Qualifications :
- BS in Chemistry (or similar field) with 3 to 5 years lab experience; OR
- Master's Degree with 0 years of experience.
- Practical experience and knowledge of protein HPLC (e.g., SEC, IEX, HIC), capillary electrophoresis, and other separation techniques as applied to protein analysis preferred.
- Experience with routine laboratory activities (e.g., sample preparation, weighing, pipetting, pH measurement, solution preparation, etc.) preferred.
- Ability to maintain a laboratory notebook in compliance with Good Laboratory/Manufacturing Practices required.
- Independent understanding and execution of established methods and techniques including operation of the relevant software required.
- Ability to multitask and work within timelines preferred.
- Experience with biologics (i.e., proteins, etc.) preferred.
- Experience with separation techniques (HPLC, capillary electrophoresis, etc.) preferred.
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,