We are seeking a Manager/Sr. Manager Analytical Development. The Manager/Senior Manager for Small Molecule Analytical Development will report directly to the Senior Director of Analytical Development and QC. This individual will be responsible for company’s CMC projects in terms of the development of analytical methodology and characterization of drug substance and drug products. This individual will work with minimal supervision to support analytical activities in contract development and manufacturing organizations (CDMOs).
- Responsible for developing and implementing analytical strategies for development stage projects to achieve optimal results.
- Identifies analytical science capabilities and technology tools needed to enable manufacturing process development, QC testing, and new drug candidate formulation development.
- Applies scientifically-driven thinking to the development of scientifically sound, well understood, and phase appropriate analytical methods for development compounds; raw materials, intermediates, drug substances and drug product.
- Manage CRO/CMO for analytical activities for drug substance and product: method development, characterization testing, etc. Review of raw data packages.
- Provide technical input in investigation of OOS and OOT root causes and and/or anomalous results investigation.
- Assemble data tables for regulatory submissions. Review, prepares and delivers technical documents for regulatory submissions.
- Contribute to specifications for drug substance and products, regulatory starting materials, IPC, intermediates, and raw materials.
- Provides support and contributes to other analytical activities as necessary.
- B.S’s degree in chemistry or pharmaceutics or equivalent.
- 10+ years of relevant working experience in analytical development in pharmaceutical industry. Being skilled in the application of cGLP/cGMP is desirable.
- Extensive analytical development background and hands on experiences with working knowledge of chemistry, analytical or pharmaceutical science.
- Detail-oriented. Ability to critically evaluate analytical data from a broad range of scientific disciplines.
- Have both broad and in-depth knowledge as well as hands-on experience in modern analytical chemistry techniques. Outstanding problem-solving abilities.
- Excellent interpersonal/ organizational skills and the ability to multi-task.
- Strong oral/ written communication skills.
- Ability to travel 10 – 20% domestic and internationally.
- Computer literacy.
EEO & Employment Eligibility
Turning Point Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Turning Point Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Turning Point Therapeutics is an E-Verify employer.
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