What are the responsibilities and job description for the Director, Analytical Development-Technical Operations position at Star Therapeutics?
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
- 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.
- Establish, review, and implement stability program for Drug Substance, Drug Product, and reference standards.
- Establish analytical method monitoring and trending to determine the suitability of methods for release and stability testing.
- Support technology transfer activities, including vendor selection, generation of risk assessments, test procedures, reviewing results, etc.
- Establish qualification and validation strategy to facilitate assay establishment in Quality Control consistent with the late phase and commercial requirements.
- Closely coordinate with Quality Assurance and Regulatory, as well as other CMC functions, Clinical and Toxicology regarding safety-related questions.
- Support regulatory filings and CDMO site audits as needed.
- Author and review technical reports and source documentation supporting regulatory submissions.
- Good understanding of cGMP environment, Quality by Design (QBD) principles for process and assay development, qualification and validation required.
- Collaborate closely with other functions to enable effective and successful project development; actively engage in cross-functional collaboration with peers to overcome challenges.
- Organize, communicate, and present complex data sets to key stakeholders and senior management.
- Requires up to 20% domestic and international travel.
- 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
Education & Professional Experience
- PhD or MS in chemistry, biology, bio/chemical engineering, or related discipline
- PhD with 10 years or Master’s degree with 12 years of experience in a scientific discipline related to biotechnology or pharmaceuticals, particularly in Analytical Development or Quality Control
- Experience with method validation for late-stage clinical/BLA readiness/commercial settings is highly desirable
- Experience managing CROs and CDMOs
Salary Range
The hiring salary range for candidates residing in California for this position is $184,000 to $230,000 annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation geographic location, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in the Company’s stock option plan.
*Please note the preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive listing of all activities, duties or responsibilities required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Star Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Star is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other legally protected status.
Salary : $184,000 - $230,000
