Analytical Development Manager
700 Technology Square, Flr 2 Cambridge, MA 02139 US
Job Description
Key Responsibilities:
- Manage the validation of analytical methods for the release and stability testing of late-stage products, ensuring compliance with regulatory requirements.
- Manage the ongoing method development and transfer activities at/or between CMO/CROs, providing technical oversight and direction and ensuring timely delivery.
- Evaluate the method readiness and make recommendations for addressing technical gaps prior to validation.
- Review validation protocols, data and reports and provide timely feedback.
- Assist with the development and implementation of analytical strategies to support PPQ and BLA readiness activities.
- Collaborate closely with cross-functional teams, including process development, regulatory affairs, and quality assurance, to ensure seamless integration of analytical activities into the overall development process.
- Stay current with industry trends, new technologies, and regulatory guidelines related to analytical development for rare disease therapeutics.
- Contribute to the preparation of regulatory documents, including INDs, NDAs, and BLAs, by providing analytical data and documentation.
- Manage the relevant timelines to ensure timely and efficient project execution.
- Bachelors or Master's degree in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry or a related field with 5-7 years’ experience or a Ph.D. in a related field with 3-5 years’ experience in analytical method development and validation within the biotechnology or pharmaceutical industry.
- Expertise in a wide range of analytical techniques, such as HPLC, LC-MS, CE, SDS-PAGE, ELISA, spectroscopy, and others.
- In-depth understanding of regulatory guidelines (e.g., ICH, FDA, EMA) pertaining to analytical method validation, product characterization, and stability studies.
- Excellent project management skills, with the ability to prioritize tasks and manage timelines.
- Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.
- Ability to work in a fast-paced dynamic environment with changing priorities, forward thinking with flexibility to support multiple development programs simultaneously.
- Detail-oriented mindset with a commitment to producing high-quality, reliable analytical data.
- Experience with rare disease drug development is a strong plus.
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