Director/Senior Director Analytical Development

Director/Senior Director of Analytical Development

(CA, hybrid or remote with frequent travel)

I've got a great opportunity to join a pioneering biotech company at the forefront of innovative biologics development, specializing in antibodies for infectious and rare diseases. They are committed to revolutionizing treatments and improving patient outcomes with a robust pipeline of potential breakthrough therapies, including a lead candidate in Phase 3 trials, they are poised to make a significant impact in healthcare.

As the Director of Analytical Development with a CMC focus, you will play a pivotal role in advancing their biologics pipeline by leading analytical strategy and development activities related to Chemistry, Manufacturing, and Controls. Reporting to the Vice President of Development, you will oversee a team of scientists and contribute to the successful submission of their first BLA while driving innovation across multiple indications. This position offers a unique opportunity to shape the future of biologics development in a dynamic and collaborative environment.

Key Responsibilities:

Develop and execute analytical strategies to support the Chemistry, Manufacturing, and Controls aspects of biologics development, ensuring robust analytical methods for product characterization, release testing, and stability studies in compliance with Good Manufacturing Practices (GMP) and ICH guidelines.

Lead and mentor a team of scientists responsible for method development, validation, and transfer for various analytical techniques pertinent to CMC, including HPLC, mass spectrometry, ELISA, and potency assays, with a strong emphasis on GMP compliance.

Drive innovation in analytical methodologies and technologies to enhance product characterization, comparability, and process understanding, while ensuring compliance with regulatory expectations and industry best practices for GMP and ICH elements.

Oversee the qualification and validation of analytical methods for CMC-related activities, including stability-indicating assays, impurity testing, and characterization of critical quality attributes (CQAs), with a focus on meeting regulatory expectations for GMP compliance.

Act as a subject matter expert on analytical development-related matters within CMC, representing the department in internal meetings, regulatory interactions, and external collaborations related to GMP and ICH elements.

Establish and maintain relationships with CROs/CMOs for outsourcing analytical testing related to CMC, ensuring timely delivery of high-quality data and results to support manufacturing activities in accordance with GMP requirements.

Contribute to the preparation of CMC sections for regulatory submissions (IND/BLA), including analytical method validation reports, specifications, and comparability assessments, with a strong focus on meeting GMP and ICH expectations.

Qualifications:

PhD or equivalent degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.

8+ years of experience in biopharmaceutical analytical development, with a focus on CMC-related activities and a proven track record of success in developing and validating methods for biologics, preferably antibodies, in compliance with GMP and ICH guidelines.

Demonstrated leadership experience, including managing and mentoring scientific teams, and a strong ability to collaborate effectively across multidisciplinary teams.

Expertise in a wide range of analytical techniques, instrumentation, and regulatory requirements relevant to CMC in biologics development, with a thorough understanding of GMP and ICH elements.

Experience with IND/BLA filings and interactions with regulatory agencies (FDA/EMA) related to CMC, with a focus on meeting GMP and ICH expectations, is highly desirable.

Strong organizational skills, attention to detail, and the ability to thrive in a fast-paced, dynamic environment