LanceSoft
Senior Associate Scientist
This job is now closed
Job Description
- Req#: 26-07789
- Initiate and manage specification change controls in a GMP setting.
- Expected contributions to general operations including review of data and authorship/review of technical documentation. Provide technical support as needed.
- Author and review SOPs and protocols in accordance with company and regulatory guidelines.
- Contribute to data review, analytical and stability sections of regulatory submissions. Assist with responses to agency requests on these sections.
- Contribute to specification assessment of existing and new products.
- Provie support in maintaining platform program specification documents.
The Senior Associate Scientist, Specifications will be responsible for specification support of siRNA drug substances and drug products. This is an onsite position.
Summary of Key Responsibilities:
Knowledge/Experience/Skill:
•BS or MS in Chemistry, Biochemistry or related disciplines.
•Minimum of 2 years of previous experience in a cGMP analytical laboratory environment.
•Preferred previous experience with stability studies designed and conducted in accordance with ICH guidelines.
•Must be a team player and open to change.
•Must have excellent communication and speaking skills. Can prepare presentations and present.
•Preferred – experience with HPLC and physico-chemical test methods of oligonucleotides. Alternatively - experience with HPLC and physico-chemical test methods of oligosaccharides or proteins.About the company
Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization, and a pioneer in providing premium end-to-end Global Workforce Solutions and IT Services to diverse clients across various domains.
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