Who We Are
Kinnate Biopharma Inc. is a clinical-stage precision oncology company focused on expanding on the promise of targeted therapies for those battling cancer.
The company is developing medicines for known oncogenic drivers where there are no approved targeted drugs and to overcome the limitations of marketed cancer therapies, such non-responsiveness or acquired and intrinsic resistance.
Kinnate has two lead clinical programs being studied in solid tumors with RAF, NRAS and FGFR-driven alterations, and is rapidly progressing a pipeline of additional small molecule drug candidates as part of the Kinnate Discovery Engine.
The company is driven by the urgency and knowledge that patients are waiting for new, effective cancer medicines. Come join us to help improve lives.
For more information, visit www.kinnate.com and follow us on LinkedIn.
Your Impact at Kinnate
We are seeking an experienced Associate Director/Director, Drug Substance (CMC) reporting to the Head of CMC to lead outsourced Small Molecule 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.
Responsibilities
Responsible for ensuring timely Small Molecule Drug Substance supply for non-clinical and clinical studies.
Lead management of CMOs for process development, tech-transfer, and manufacturing of Small Molecule Drug Substances for 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 regulatoryng materials, intermediates, and drug substances.
Develop robust manufacturing processes that maintain high product quality, increased process efficiency and robustness with reduced manufacturing costs.
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 small molecule drugs substance manufacturing processes.
Demonstrated expertise in developing a sound drug substance control strategy and implantation of modern scientific technologies in chemistry/chemical engineering.
Experience working with US and International Contract Manufacturing Organizations.
Experience with CMC program management is a plus.
Excellent written and oral communication and presentation skills.
Strong problem solving, decision making, planning, analytical and project management skills.
Demonstrated track record in leading external chemistry and manufacturing teams and collaborations.
Demonstrated ability in leading small molecule 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 substance development, CRO/CDMO management, manufacturing, and regulatory CMC.
Up to 25% travel may be needed (domestic and international).
NOTE: This position summary is not intended to be all inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
We offer a competitive total rewards package that provide our employees with the resources to pursue their goals, both at work and in their personal lives. The salary reasonably expected to be paid for this role is $160,000 to $205,000. The actual compensation and seniority level for this position will be determined based on relevant experience and qualifications. This position is eligible for an annual cash bonus and equity awards. Our employees are also eligible to receive other benefits including:
· Unlimited Paid Time Off
· 11 Company Paid Holidays - plus 2 annual paid “Refresher Days”
· Wide variety of comprehensive health, dental, and vision packages – most with minimal to no out-of-pocket expenses for employees
· Company contribution to 401k plan
· Employee stock purchase program
· Annual Massage Days
· Free local gym memberships
· Healthy Lifestyle Reimbursement Program
· Home Office Reimbursement Program
Kinnate recognizes the importance of balance and flexibility in our work environment. Physical presence at the Kinnate worksites or physical presence in the field is an essential job function of this role which the company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the company culture.
Kinnate is proud to be responsible members of our communities. Subject to applicable law, we require all our employees to be fully vaccinated and boosted against the COVID-19 virus. Therefore, all applicants seeking a role located in the U.S. must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.
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.