Sr Scientist
1555 Adams Dr Los Altos Hills, CA 94022 US
Job Description
HM's Top 3:
- Technical skills as describes in the job description (HPLC, UPLC, GC, Dissolution/Elution (USP Apparatus 2), FTIR, GPC and Karl Fisher)
- Experience on method development/ validation Â
- Experience in advanced data analysis
Education Required: Requires a Baccalaureate degree and minimum 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience. Nice to have advanced degree in Chemistry
Years’ Experience Required: 4 or 2 depending on the education
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In this exciting role as a Senior Scientist, you will have responsibility for analytical test development, method verifications and validation in support of new and existing combination product Quality Control.
- The Senior Scientist will require a variety of technical skills including HPLC, UPLC, GC, Dissolution/Elution (USP Apparatus 2), FTIR, GPC and Karl Fisher.
- The individual will make and record observations; perform calculations; and collect and prepare data for evaluation.
- This individual will perform technical and recordkeeping duties in conformance with company policies, current Good Lab Practices (cGLP), current Good Manufacturing Practices (cGMP), and technical procedures in Quality Control/Assurance and/or Research and Development group.
- In addition, the individual will be the liaison between the external laboratories that are doing testing with the internal stakeholders as the analytical/CMC lead ensuring product releases are done in a timely manner and all the regulatory compliance requirements are met.
Responsibilities include:
- Provide technical input, oversight and direction to assigned projects and activities in support of process improvements to current methods.
- Lead the external laboratory collaborations including reviewing data packages, test results, lab investigations and any method transfers
- Coordinate external laboratory data and information with the internal teams for product release/ annual stability
- Write and review test methods, method verification/validation protocols, and method verification/validation reports.
- Participate in cross functional teams as a representative of the Analytical Quality Control group.
- Support internal/external audits for the analytical/CMC related topics
- Provide mentoring and coaching to the Analytical Development staff when needed
- Thorough knowledge and experience with cGMP and ICH guidelines
- Experience in developing and validating analytical test methods
Nice To Have
- Advanced degree in chemistry
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