Sr Manager, Analytical Development
Proclinical is seeking a talented Sr Manager, Analytical Development to join an exciting clinical stage biotech in the San Diego area and to lead Analytical Development activities in a virtual environment. The Senior Manager, Analytical Development serves as analytical subject matter expert and is responsible for analytical method development, validation, and transfer in compliance with cGMP and international regulatory standards for drug substances and drug products generated by external laboratories and manufacturers. The candidate must have extensive knowledge of FDA, ICH and EU regulatory requirements and the ability to work effectively in a virtual environment.
- Manage and oversee method development, validation, and transfer for small molecule products at CDMOs/CROs.
- Oversee specification setting of drug substance and drug product at CDMOs/CROs.
- Perform technical reviews of analytical method validation protocol/report and method transfer protocol/report and SOPs as well as experimental reports.
- Manage development activities such as IPC and release testing.
- Manage research activities such as impurity characterization.
- Provide scientific and technical support on internal and external project teams.
- Assist in troubleshooting OOS and OOT root causes. Perform evaluation and recommend corrective actions when necessary.
- Assist in preparation of submission sections related to DS and DP analytical package and structural characterization.
- Provide scientific and technical support to internal and external groups to ensure that products are manufactured and released in compliance with all applicable regulations.
Skills and Requirements:
- Bachelor's Degree in chemistry, biochemistry, or related Life Sciences discipline. Equivalent combination of education and applicable job experience may be considered.
- Minimum 6 years of relevant experience in Biotech or Pharmaceutical industry.
- 3-5 years of extensive analytical development, validation and transfer background with experience reviewing analytical data and managing analytical development activities from external CRO/CMOs.
- Direct knowledge of HPLC, GC, MS, NMR, IR, dissolution, and other relevant analytical methods.
- Maintain up-to-date knowledge of US and EU GMPs, USP, Ph. Eur, and ICH guidelines as applicable to cGMP manufacturing and control of API's and drug products.
- Strong professional experience in a similar role within the pharmaceutical industry.
- Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
- Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
- Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
If you are having difficulty in applying or if you have any questions, please contact Max Robinson at (+1) 857-362-9542 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.