Director, Drug Substance Manufacturing

3 weeks ago

Boston, United States Third Rock Ventures Full time

As a word, Rapport describes relationships characterized by understanding, communication, teamwork, and trust. We reflect those qualities in our daily work, where we operate as one committed team that captures the collective knowledge and experience of all our members to maximally improve patients' lives. And at a higher level we share an ambition and a passion to create impactful neuromedicines, with fewer side effects, that allow patients and their families to live healthier and more fulfilling lives.

On a molecular scale, our deep understanding of the intricate relationships between receptors, their associated proteins, and their distributions in specific cell types and brain regions enables us to precisely direct medicines to the neural circuits underlying disease pathophysiology.

We are seeking a highly motivated Director or Senior Director of Drug Substance Manufacturing to join its growing CMC Development team and lead the strategic, tactical, and scientific aspects of process chemistry development, analytical chemistry development, and non-GMP/GMP manufacturing activities for multiple small molecule programs in pre-clinical and clinical development.

Responsibilities:

* Optimize synthetic chemistry routes for API and raw materials to maximize efficiency and cost effectiveness
* Implement analytical methods for monitoring material quality attributes in a phase-appropriate manner
* Manage external geographically-dispersed CDMO collaborators to ensure high-quality documentation and execution of time-sensitive deliverables
* Serve as a technology lead for tech transfer activities
* Coordinate with Drug Product colleagues for GMP material transitions and setting of specifications for control aspects
* Review Master Batch Records and analytical method documentation
* Prepare regulatory documents
* Collaborate with internal/external stakeholders on program objectives
* Travel to external CDMOs for on-site activities (~10% of work time)

Qualifications:

* M.S./Ph.D. in Organic Chemistry or Chemical Engineering
* 10+ years industrial experience with M.S. or 8+ years experience with Ph.D., with preference of experience in small biotech companies with external manufacturing capability
* Track record on advancing multiple pre-clinical and clinical assets into and through clinical development in a rapid- and risk-balanced approach
* Experience in phase-appropriate GMP and SOP demonstration
* Experience in preparing INDs, IMPDs, and other regulatory documents
* Deep understanding of the integrated role of the CMC function in the overall development team and its relationship to the functions of quality, regulatory, clinical, safety, IP, and contracting
* Willingness to operate with a sense of urgency and ability to make rational risk-based decisions

Rapport Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.

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