Who We Are
We are a
dedicated team of professionals who take our work very seriously, but not
ourselves too seriously. We are driven
to deliver new medicines to cancer patients who desperately need
solutions. We are a collection of
individuals with diverse backgrounds and personalities, yet all united by this purpose
to ignite the precision medicine revolution by delivering targeted therapies
for those battling cancers. We are motivated by a profound sense of urgency and
passion to create medicines with life-saving potential. If you enjoy co-elevating your colleagues and
want to be part of a team of like-minded individuals united by a relentless
pursuit to end cancer, then Kinnate may be the home for you.
Your impact at Kinnate
As the Director of Analytical Development (CMC) you will support expansion of the company’s operations, reporting to the Head of CMC, and will be responsible for all Analytical Development functions for small molecule Drug Substance and oral solid dose Drug Product through all phases of development from pre-clinical to late phase/commercial. New oncology therapy breakthroughs await your creative spirit and “roll-up your sleeves” approach because #patientsarewaiting.
- Be responsible for providing strategic leadership and tactical support for all analytical activities for small molecule drug substance and oral solid dose drug product including support for global regulatory applications for authorization of clinical trials in all phases of drug development.
- Develop phase appropriate strategies and analytical testing plans for regulatory starting materials, intermediates, drug substance and drug product in compliance with regulatory requirements.
- Develop a network of reliable CDMOs or third-party testing labs to support Kinnate’s development programs.
- Guide, review and approve analytical development strategies/work at drug substance and drug product CDMOs.
- Oversee all analytical activities conducted at third party labs including structure elucidation, method development and validation, stability studies, method transfer, testing of clinical materials and reference standards.
- Manage stability studies to support clinical and non-clinical candidates including data trending.
- Collaborate with other internal groups and external contract laboratories to ensure overall program goals are achieved.
- Collaborate with Regulatory to develop strategy for regulatory submissions. Author and review regulatory submissions; participate in scientific advice preparations and meetings.
- MS or PhD in Analytical Chemistry, Chemistry, Biochemistry, or equivalent scientific discipline.
- 10+ years experience in analytical methods development supporting small molecule and solid oral dosage development programs.
- Must have at least 5 years experience managing an analytical group and leading the analytical function in a company.
- Experienced with managing work for numerous clinical candidates at multiple Contract Manufacturing Organizations and/or Contract Testing Labs.
- In-depth experience with the development troubleshooting and validation of analytical methods (HPLC, GC, dissolution, compendial methods, etc.), identification of impurities and degradation products, reference standard qualification.
- Ability to develop comprehensive analytical understanding of products in pre-clinical and clinical development.
- Thorough knowledge of ICH Q1, Q2, Q3, Q6 and Q7 guidelines as applicable to drug substance and drug product quality aspects.
- Experience preparing and updating regulatory filings (IND, IMPD, NDA, MAA).
- Ability to function efficiently and independently in a changing environment.
- Self-motivated, detail-oriented, excellent interpersonal and writing skills.
Kinnate Biopharma Inc. recently closed our
$276M initial public offering and are listed on 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 the San
Francisco Bay Area. We are a small but growing precision oncology company
with a bright future.
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