Associate Director/Director – Drug Substance (CMC)

Who we are:

Kinnate Biopharma is driven by the urgency of cancer patients who need more effective therapies. We utilize our deep expertise in structure-based drug discovery, translational research and patient-driven precision medicine, which we refer to as our Kinnate Discovery Engine, to develop targeted therapies. Our lead programs include candidates in preclinical development for cancers that are driven by specific oncogenic alterations in either the BRAF kinase gene, or in the FGFR2 and FGFR3 kinase genes. To help move our programs forward, Kinnate has brought together a management team of precision oncology experts and scientific advisors who publish widely-cited research on topics relevant to the study and treatment of cancer and lead clinical units at experienced precision medicine cancer centers in the United States.

Summary Description of Role:

We are seeking an experienced Associate Director/Director, Drug Substance (CMC) reporting to the Head of CMC to lead all outsourced Drug Substance process development and manufacturing activities and internal CMC aspects for Kinnate’s expanding pipeline. The individual will interact with Discovery, Non-Clinical and Drug Product colleagues to develop and execute strategies to ensure necessary Drug Substance supply for toxicology and clinical studies.

Your impact at Kinnate...

Responsible for ensuring timely Drug Substance supply for non-clinical and clinical studies.
Lead management of CMOs for process development and manufacturing Small Molecule Drug Substances tox and cGMP supplies.
Develop and execute CMC strategies for early phase as well as late phase Drug Substance clinical supplies.
Responsible for phase appropriate synthetic route design, practical implementation of synthetic processes and controls for regulatory materials, intermediates, and drug substances.
Lead impurities origin, fate and effect studies, genotoxic impurity evaluation and establish the framework of for the control strategy of the drug substance from early development with a long-term vision of the commercial process.
Coordinate with internal and external analytical/quality control, quality assurance, and regulatory personnel to resolve technical issues or deviations during cGMP production.
Create and manage contracts, requests for pricing, supply agreements, etc. related to drug substance manufacturing.
Ensure activities are executed in alignment with established Quality Agreements. Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings as needed.
Work closely with cross functional teams to ensure seamless transitions between drug substance and drug product programs and suppliers.
Develop and maintain collaborative relationships with internal stakeholders (e.g., Discovery, Non-Clinical, CMC, Clinical Operations, Regulatory, Quality, Finance, etc.) to deliver Kinnate’s internal goals and objectives.

The Right Stuff....

PhD in Synthetic Organic Chemistry or another relevant field with relevant drug substance development experience in biopharmaceutical industry. MS with relevant experience may be considered.
10+ combined years of experience in small molecule Drug Substance Process Development, cGMP Manufacturing, Contract Manufacturing supporting early and late phase clinical supplies.
Expert knowledge in synthetic organic chemistry, process development and scale-up of drugs substance manufacturing processes.
Experience working with US and International Contract Manufacturing Organizations.
Experience with CMC program management is a plus.

Competencies:

Excellent written and oral communication and presentation skills.
Strong problem solving, decision making, planning, analytical and project management skills.
Demonstrated track record in leading chemistry teams and external collaborations.
Demonstrated ability in leading drug substance production campaigns with successful deliveries under aggressive timelines.
Ability to multi-task and shift priorities rapidly to meet tight deadlines.
Demonstrated knowledge of drug development, CRO/CDMO management, manufacturing, supply chain management and regulatory CMC.

Other:

Up to 20% travel may be needed (domestic and international).
Position will be based in San Diego, CA.

Kinnate Biopharma Inc. closed our $276M initial public offering in December 2020 and are listed on the Nasdaq. Prior to that, we closed three significant venture capital financings, including our $98M Series C round in July and August 2020 and our $74.5M Series B round in December 2019. Kinnate has a passionate and seasoned Team, guided by industry leaders in precision medicine and drug discovery, developing a focused portfolio strategy, and leveraging unique team expertise. Our Research and Development team is based primarily in San Diego, California and a portion of our management team is based in San Francisco, California. We are a small but growing precision oncology company with a bright future.

EEO & EMPLOYMENT ELIGIBILITY

Kinnate Biopharma Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Kinnate Biopharma Inc. also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of applicable law.

Recruitment & Staffing Agencies: Kinnate Biopharma, Inc. does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Kinnate or its employees is strictly prohibited unless contacted directly by Kinnate’s internal HR Team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Kinnate, and Kinnate will not owe any referral or other fees with respect thereto.