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 Associate Director, Drug Product Development (small molecule oral solids dosage), you will support expansion of the company’s operations and will support Drug Product projects from 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 #patients are waiting.
- Drug product development of oral solid dosage from lead candidate optimization to clinical development and through commercialization. Experience in pre-formulation, formulation development, and manufacturing process selection and scale-up based on Quality by Design principles.
- Guidance and oversight of CMOs through technology transfer, formulation and process development, optimization, qualification and validation of activities related to DP manufacturing operations. Be on-site, as necessary.
- Develop phase-appropriate oral solids dosage forms for clinical and commercial use. Experience with enabled formulations such as spray dried dispersions is a plus.
- Design and oversee pre-formulation, formulation and process development, scale-up and clinical manufacturing activities, including primary packaging and labeling.
- Author and review development reports, technical memos, batch records, and relevant CMC sections for various regulatory filings (IND, IMPD, NDA, MAA).
- Good understanding of pre-formulation principles including solid-state characterization is a plus.
- Participate in vendor selection and contract negotiations with external partners.
- Create and manage drug product risk assessment and risk register.
- Assure suitable forecasts of API and DP needs for the clinical programs to ensure uninterrupted drug supply.
- Serve as a drug product SME on project teams and/or sub-teams.
The Right Stuff:
- PhD in Pharmaceutical Sciences, Chemical Engineering or related Physical Sciences with 7+ years of experience, or MS with 9+ years, or working in small molecule oral solids drug product development in the pharmaceutical or biotechnology industry.
- In-depth knowledge and hands-on experience in pre-formulation, formulation and process development of small molecule oral solid dosage forms.
- Proven experience managing scale-up and manufacturing of pharmaceutical dosage forms.
- Thorough understanding of cGMP compliance and ICH guidelines.
- Experience writing CMC drug product sections in regulatory filings.
- Direct experience managing CMOs. GMP experience is required.
- Ability to thrive in a highly entrepreneurial, fast paced, and capital efficient environment.
- Strong written and communication skills; and an ability to work effectively with a diverse team of co-workers in a dynamic environment.
- Positive, adaptable, can-do attitude with quick learning ability.
- Ability to travel (up to 20%) and work flexible hours, as required.
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.
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.