Position Summary

The Director, Analytical Development-Technical Operations will guide and oversee analytical method development, qualification, validation, and stability for development programs at Star Therapeutics. They will be responsible for working with external partners and CDMOs to develop and implement the analytical and stability strategy that will meet various stages of the development program lifecycle including early phase clinical trials, through the eventual late phase clinical trials and commercialization.

Primary Responsibilities

1. Guide and collaborate with CDMO to design and perform robust method development and validation employing phase-appropriate approaches (pre-clinical through commercialization) for impurity and degradation products, reference standards, and characterization as applicable for monoclonal antibodies.
2. Establish, review, and implement stability program for Drug Substance, Drug Product, and reference standards.
3. Establish analytical method monitoring and trending to determine the suitability of methods for release and stability testing.
4. Support technology transfer activities, including vendor selection, generation of risk assessments, test procedures, reviewing results, etc.
5. Establish qualification and validation strategy to facilitate assay establishment in Quality Control consistent with the late phase and commercial requirements.
6. Closely coordinate with Quality Assurance and Regulatory, as well as other CMC functions, Clinical and Toxicology regarding safety-related questions.
7. Support regulatory filings and CDMO site audits as needed.
8. Author and review technical reports and source documentation supporting regulatory submissions.
9. Good understanding of cGMP environment, Quality by Design (QBD) principles for process and assay development, qualification and validation required.
10. Collaborate closely with other functions to enable effective and successful project development; actively engage in cross-functional collaboration with peers to overcome challenges.
11. Organize, communicate, and present complex data sets to key stakeholders and senior management.
12. Requires up to 20% domestic and international travel.
13. Performs other related duties as assigned.

Qualifications / Skills

• Demonstrated track record of successfully developing, qualifying, and transferring analytical methods
• Strong background in physical chemistry, biochemistry, and other analytical methods for monoclonal antibody products
• Strong grasp of statistical approaches for design of experiments (DoE) analytical method development, robustness testing, and data analysis
• In depth knowledge of US (required) and European (preferred) regulatory requirements for cGMP
• Experience drafting, reviewing and submitting required documentation pertaining to the cGMP environment
• Experience in transfer of methods to Quality Control, management of external vendors (central testing labs, contract manufacturing organizations), partnerships, with the ability to manage multiple technical projects successfully
• Experience with regulatory filing including, e.g IND/IMPD/BLA/MAA submissions, is desired.
• Excellent strategic thinking skills with demonstrated ability to successfully create and implement short- and long-range plans to support product development strategy
• Proficient in analyzing technical data and preparing written technical reports
• Excellent oral and written communication skills, detail-oriented, scientifically driven
• Ability to navigate and be successful in a fast-paced work environment