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About Us:

Timberlyne Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of transformational therapies for high unmet medical needs.  Timberlyne’s lead program is CM313, an IgG1 monoclonal antibody with enhanced complement-dependent cytotoxicity that targets CD38. By targeting CD38, which is highly expressed on plasma cells, NK cells, and other immune cells, CM313 modulates multiple immune cell types leading to both rapid and durable responses across a range of autoimmune diseases and cancers.

Position Summary:

Timberlyne is searching for a Director of Analytical Development and Formulation. The position will contribute to the formulation, drug product development and GMP drug product manufacturing for Timberlyne’s large molecule clinical pipeline. The successful candidate will manage and collaborate with contract development and manufacturing vendors and ensure timely delivery of drug product in support of programs and ongoing clinical development programs. The Director will further provide written support for regulatory CMC filings.  The responsibilities are included but not limited to the following.

Essential Responsibilities:

• Independently lead analytical development, transfer, qualification, 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.
• Oversee pivotal analytical development deliverables for programs by serving as CMC analytical lead as well as providing technical oversight and mentorship to other CMC analytical leads.
• Develop and optimize chromatography-, capillary, spectroscopy-, and mass spectrometry-based analytical methods for product quality assessment.
• Perform in-depth physical/chemical characterization of complex programs supporting elucidation of structure, critical quality attribute (CQA) assessments, and comparability exercises.
• Define and execute overall analytical development strategy to enable accelerated CMC development timelines.
• Ensure rapid and timely analytical support for cell-line, bioprocess, and formulation development and process characterization/process validation (PC/PV) activities.
• Provide technical guidance during investigations at CMOs/CROs in collaboration with Quality
• Author and review technical development documents, relevant CMC sections of health authority submissions and support agency interactions
• Support technical execution and troubleshooting in the laboratory, as needed.
• Drive the establishment of internal state-of-the-art analytical capabilities to support accelerated CMC development.

Skills and Experience:

• PhD in Analytical Chemistry, Biochemistry, Chemical Engineering, Biophysics, or related scientific discipline plus a minimum of 10+ years analytical development experience in the biotech/biopharma industry; or BS/MS with a minimum of 15+ years of experience.
• Experience working in the auto-immune space preferred
• Previous experience serving as CMC analytical lead through BLA/MAA submission for large molecule programs and experience 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 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 for identification and characterization of product variants, and comparability evaluations.
• Prior experience with developing bioanalytical assays or advanced mass spectrometry characterization approaches 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
• Excellent oral and written communication skills
• Motivated, detail-oriented, scientifically driven individual with a creative approach to problem solving.

How To Apply:  Please send your resume to careers@timberlyne-tx.com

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity/expression, national origin, disability, medical condition, age, marital status, status as a protected veteran, or any other legally protected characteristic.