Analytical Development Manager
Analytical Development Manager Opportunity at Nanosyn, Inc.
Nanosyn is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing services to pharmaceutical clients worldwide. We serve our clients through our facilities located in Santa Clara, Santa Rosa and Hayward, CA. We offer a comprehensive range of services including drug discovery solutions, process chemistry & pharmaceutical development, clinical trial manufacturing, commercial supply of APIs and finished dosage forms. Our capability as an integrated service provider and our experience with various technologies enables us to serve our pharmaceutical clients worldwide.
For more details, please visit www.nanosyn.com
Summary: Leadership in the area of analytical development at Nanosyn.
Purpose of Job: To ensure availability of appropriate and accurate analytical methods and providing testing.
Location: Hayward, California
Essential Duties / Responsibilities:
- Timely development of analytical methods for in-process and release testing at various stages of product life cycle
- Providing technical and analytical assistance/solution in impurity identification efforts
- Assessment of test methods provided by clients
- Assessment of analytical efforts and their cost on new (potential) projects.
- Ensuring proper record-keeping, full traceability, and efficient communication of analytical findings, observations and results across organization
- Managing a library of analytical methods
Member of the Quality Unit:
- Supporting QC activities, as needed
- Providing analytical development reports to QC
- Participation in development of analytical validation/qualification/degradation/stability studies protocols and reports (including analytical test methods used in cleaning validation/verification)
- Technical assistance in establishment of specifications for Active Pharmaceutical Ingredients
- Providing technical coaching to colleagues
- Providing assistance during cGMP audits and inspections
- Performing and/or providing assistance for analytical testing for R&D and cGMP applications, as needed
- Providing training to chemists on developed methods and setting the methods on R&D equipment
- Providing training on equipment use
- Troubleshooting of all analytical equipment in the facility
- Helping create a positive work environment
- Other reasonable duties may be assigned as necessary
- Advanced degree in chemistry
- Minimum 5-year experience in analytical development, validation and testing in QC environment for various compounds
- Strong analytical skills
- Hands-on experience with a broad range of analytical instrumentation, including HPLC, GC, MS, FTIR, UV-Vis Spectrophotometry and new analytical techniques
- Strong organizational skills and ability to multitask
- Knowledge of regulatory requirements, cGMP and ICH guidelines
- Strong communication skills
Physical Demands/Work Environment:
- Ability to safely handle hazardous materials
- Ability to lift 50 pounds
- Ability to bend to reach floor level