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.

Manager / Senior Manager Drug Product Development, CMC

Key Responsibilities:

·         Drug product development 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.

·         Conduct 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

 

·         MS in Pharmaceutical Sciences, Chemical Engineering or related Physical Sciences with 5+ years, or PhD with 3+ years of experience working in oral solids drug product development in the pharmaceutical or biotechnology industry.

·         In-depth knowledge and hands-on experience in 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.

 

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. All full-time employees are eligible to receive: cash salaries, bonuses and equity awards; employee stock purchase program; unlimited paid time off; annual paid “refresher” days; annual massage days[PS2] ; highly subsidized health benefits packages with a wide variety of provider options and minimal to no out of pocket expenses; monthly stipend for employees who elect no health coverage through Kinnate; life and accidental death and disability insurance; company contribution to 401k plan; free local gym memberships (in San Diego and San Francisco[PS3] ); healthy lifestyle reimbursement program; home office reimbursement program; and commuter and walking/biking benefits. 

 

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.