Staff Scientist and Group Leader for Chemistry, Manufacturing and Controls for Small Molecules, Biol
The National Center for Advancing Translational Sciences (NCATS), a major research component of the National Institutes of Health, is seeking applications from exceptional scientists to serve as a staff scientist and group leader for preclinical development projects that require chemistry, manufacturing and controls (CMC), process development and good manufacturing practices (GMP) in drug substance manufacturing within the Therapeutic Development Branch (TDB) of the Division of Preclinical Innovation.
The TDB partners with collaborators — academic institutions, foundations and the private industry — to implement preclinical development projects that lead to investigational new drug (IND) applications for new therapeutics. These projects play a leading role in the NCATS mission to develop new ways to reduce, remove or bypass bottlenecks across the entire continuum of translational science and to address rare and neglected diseases. Group leaders are critical to the success of TDB, and the CMC group leader must possess an intimate knowledge of chemical process research and development, biologics development, gene therapies (viral and oligonucleotide based) development and active pharmaceutical ingredient (API) manufacturing. As a contracting officer representative (COR) in a direct scientific oversight capacity, they also will play a role in drug product manufacturing and manage the activities of external manufacturers (e.g., contract manufacturing organizations).
The selected candidate will serve as an integral member of the strategic leadership team of the TDB and be involved in all aspects of programmatic design and implementation for the Branch. The selected candidate will work collaboratively with discipline area leads, project managers, scientists and operations staff in the Branch to evaluate, develop and implement specific programs and projects. Specific duties include monitoring and directing chemical process development and optimization, tracking performance measures, reviewing documents and reports, identifying problems, and proposing corrective solutions while coordinating with contractors and vendors.
Additionally, the selected candidate will manage intellectual property by contributing to Research Collaborative Agreements, Cooperative Research and Development Agreements, project plans, team meetings and other reports. Training and experience in Federal Acquisition Certification for Contracting Officer’s Representatives and/or certification at the COR II level or above, although not required before hire, will be considered a plus.
The selected candidate must have excellent interpersonal skills, including the ability to communicate clearly and succinctly in a timely manner and demonstrate the ability to foster important relationships with collaborators and key stakeholders. The selected candidate must maintain integrity and accuracy of project information to meet team, management and portfolio requirements, using project management tools and such applications as Microsoft Teams. The selected candidate also is required to speak and write clearly and effectively and to work collaboratively with colleagues to achieve project, team and organizational goals.
Each applicant must hold a doctoral degree (M.D., Ph.D. or equivalent) in a relevant field and have hands-on experience in all aspects of chemical process development and manufacturing for small-molecule APIs, biologic therapeutics, and/or viral and oligonucleotide-based gene therapies. Additionally, an intimate knowledge of GMP and the regulatory requirements and documentation is required to support the CMC sections of the IND applications to the U.S. Food and Drug Administration.
The current salary range is commensurate with experience and accomplishments; a full civil service package of benefits (including retirement, health, life and long-term care insurance, Thrift Savings Plan participation, etc.) is available.
How to Apply
Please submit (via email) a cover letter describing your interest in the position, including a career synopsis (1–3 pages) describing prior CMC activities and team leadership experience; a current curriculum vitae with a complete bibliography; and the names of and contact information for three references to: NCATSTDBHiring@nih.gov. To be accepted for review, you must cite “NCATS33-0003; Staff Scientist, Group Leader” in the subject line of your email.
The position will remain open for 30 days from ad posting. Learn more about intramural research at NCATS.
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