Backed by GV.
About the role
This position is classified as exempt. The anticipated annual base salary range for candidates who will work in Watertown is $222,329 to $243,300. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states.
What they're looking for
- Ph.D. in Organic Chemistry, or related discipline with a minimum of 12+ years of experience, or Master with a minimum of 15+ years of experience in the Chemical Development of small-molecule pharmaceuticals
- Demonstrated successful leadership in a pharmaceutical CMC drug substance development role
- Track record of success in leading and managing small-molecule drug substance programs in a 100% outsourced environment
- Strong vendor/supplier management skills and excellent communication and cross-functional collaboration skills
- Broad experience working with and managing external CDMO partners, including use of performance and quality metrics and MSA negotiation
- Expertise in small molecule process development and oversight of GMP manufacturing, including tech transfer and process validation
More about this role
The Director, Chemical Development will have overall responsibility for leading and managing development and manufacturing activities for drug substance, DS intermediates, and starting materials for one or more Treeline programs. The scope of the role encompasses process development, scale-up, and characterization/design space mapping of the manufacturing process of a drug candidate, up to and including process performance qualification (PPQ). Operating within a virtual (100% outsourced) business model, the incumbent will have accountability for CDMO selection and the development of strong and enduring business partnerships supporting assigned programs. The successful candidate will also assume a key leadership role in the development, review, and approval of Module 3 sections of CTD regulatory submissions, written responses to regulatory authorities, and TPP/QTPPs.
The successful candidate will be an experienced process chemist with significant experience in Chemical Development and strong familiarity with the other CMC disciplines and in navigating interdisciplinary connections associated with successful CMC development. S/he will possess strong leadership, management and...
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