Director, Analytical Development (AC20-220)

Catalyst Biosciences has an exciting opening and is seeking a Director, Analytical Development. This impactful position will report to the SVP of Biologics Development and Manufacturing and support our pipeline of biologics. We are seeking a talented and motivated Director to provide strategic technical leadership for analytical development, qualification and validation and extended characterization activities for our early and late-stage assets.

This individual will also be responsible for preparation of regulatory documentation, specifically, analytical sections in Quality Module 3 and contribute to the overall strategy for regulatory submissions to support the Hemostasis and Complement program. A thorough understanding of relevant ICH guidelines and health authority expectations is required. Additional responsibilities include analytical method transfer, test method development, and phase appropriate validation for both drug substance and drug product methods, as well as a review of analytical packages for release of clinical/commercial supplies (DS and DP). The position requires close collaboration with CMC scientists and the Quality organization. Working knowledge of various analytical techniques to support process control strategy for DS, DP and extended characterization studies is required.

**Title/level to commensurate with education and experience.

ABOUT CATALYST BIOSCIENCES

Catalyst is a clinical-stage biopharmaceutical company focused on developing novel medicines to address important unmet needs within Hemophilia and complement related disorders. Catalyst has compounds that span the value chain from the earliest discovery to late stage clinical trials with the intent of commercialization.

RESPONSIBILITIES

• Independently lead and manage analytical development and product characterization activities for one or more molecules in CMC development including managing CDMO interactions and driving the development and implementation of overall analytical control strategy.
• Provide oversight of analytical method transfer, qualification, and validation activities at CDMOs.
• Manage activities related to analytical method development, optimization, troubleshooting, qualification, and validation activities for starting materials, process intermediates, drug substance, and drug product internally and across CMOs.
• Identify and recommend analytical methodologies to support chemical development, formulation development, QC and stability testing.
• Assist in defining and executing overall biologics analytical development strategy to enable accelerated CMC development timelines.,
• Oversight of 3rd party development of analytical methods, method validation, and investigations for out of specification, out of trend, and/or anomalous results
• Develop and optimize HPLC-SEC, CESDS ,UV-Vis Spectroscopy, ELISA, FRET and mass spectrometry-based analytical methods for product quality assessment.
• Provide technical guidance during testing-related investigations at CMOs/CROs in collaboration with Quality.
• Author and review technical development documents and relevant sections of health authority filings.
• Ensure rapid and timely analytical support for cell-line, bioprocess, and formulation development activities.
• Maintain proficiency in the latest analytical technologies as well as emerging analytical development strategies

REQUIREMENTS

• PhD in Analytical Chemistry, Biochemistry, Biophysics, or related scientific discipline plus a minimum of 10+ years analytical development experience for protein therapeutics in the biotech/biopharma industry.
• Previous experience successfully managing multidisciplinary analytical and quality teams to meet program milestones and timelines.
• Demonstrated track record of successfully transferring and qualifying analytical methods at CMOs for Biologics development programs including familiarity with applicable GMP requirements
• In-depth knowledge and extensive hands-on experience in developing a wide array of analytical protein characterization and biophysical methods (e.g. HPLC-based methods, cIEF, capillary electrophoresis, LC/MS, peptide mapping, spectrophotometry, SPR, light scattering, etc.)
• Strong background in developing mass spectrometry-based methods (Intact/reduced MS, peptide mapping, N-/O-glycosylation profiling, disulfide linkage determination, LC-MS/MS analysis) for protein sequence confirmation, identification and characterization of product variants, and comparability evaluations considered highly preferable.
• Prior experience with developing bioanalytical assays or advanced mass spectrometry characterization approaches (tandem mass spectrometry, quantitative analysis, hydrogen-deuterium exchange, etc.) considered a plus.
• Strong grasp of statistical approaches for design-of-experiments (DoE) analytical method development, robustness testing, and data analysis.
• Demonstrated ability to work effectively and collaboratively with other scientists on cross-functional projects teams as well as CDMOs.
• Ability to make thoughtful and meaningful recommendations and/or manage relationships in order to drive efficient advancement of the portfolio.
• Ability to balance competing priorities and thrive in a dynamic, fast-paced environment.
• Excellent critical thinking, scientific problem-solving, and organizational skills is a must.
• Excellent oral and written communication skills is a must.
• Ability to effectively organize and prioritize tasks to achieve established deadlines
• Ability to multi-task and good adapt rapidly to changing business requirements in a dynamic corporate environment
• Motivated, detail-oriented, scientifically driven individual with a creative approach to problem solving.