Chemist II
Chemist II
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job Description:
The Analytical Development Lake County group within PDS&T is responsible for support of programs that are preparing for commercial development. The team leads commercial method development optimization robustness and validation. In collaboration with crossfunctional 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 Client 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.
The Analytical Development Lake County group within PDS&T is looking for a contractor to support method development robustness and validation studies. Additional laboratory testing to be assigned as appropriate.
Responsibilities:
- Develop optimize and validate analytical methods for proteinbased biologics.
- Conduct separation techniques including HPLC (SEC IEX HIC) and capillary electrophoresis.
- Perform routine laboratory tasks such as sample preparation weighing pipetting pH measurement and solution preparation.
- Maintain accurate laboratory records in compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- Analyze and interpret data troubleshoot analytical methods and support commercial formulation and process development studies.
- Collaborate with crossfunctional teams to ensure robust analytical methods for commercial QC labs.
- Support clinical supplies release testing and stability studies.
Requirements:
- BS in Chemistry (or similar field) with 3 to 5 years lab experience or a masters 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 of established methods and techniques including operation of the relevant software required.
- Ability to multitask and work within timelines preferred.
Skills:
- BS in Chemistry (or related field) 3 to 5 yrs lab experience or a masters degree.
- Experience with good laboratory/manufacture practices.
- Experience with separation techniques (HPLC capillary electrophoresis etc..
- Experience with biologics (i.e. proteins etc. preferred.
- Ability to multitask and work within timelines preferred.
Employment Type
Full Time
