Associate Director, Formulations
Location
South San Francisco, CA | United States
Job description
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility.
As the Associate Director of Formulations, reporting to the Sr. Director of Drug Product, you will be responsible for the development of multiple early stage and late stage development compounds. You will provide day-to-day hands-on leadership and help drive the direction of formulations at Cytokinetics!
Responsibilities
- Manage technical activities of clinical drug product manufacturing at contract manufacturers (CMOs). Activities include support and involvement with planning and scheduling of manufacturing, formulation development and process optimization, review and approval of drug product batch records, and monitoring of manufacturing
- Lead formulation development activities for clinical candidates
- Participate in strategic planning for formulation development for clinical candidates
- Engage and collaborate with CMOs for formulation development and process optimization
- Develop and support the team’s emerging ability in developing methods, techniques and evaluation criteria for obtaining results and interpreting experimental outcomes
- Drive implementation of innovative technologies
- Contribute drug product expertise in support of global CMC regulatory strategy,
- Author relevant pharmaceutical and manufacturing development sections of clinical and commercial regulatory filings
- Conduct data input, analysis, and interpretation and write technical protocols and reports
- Apply formulation development principles and techniques to products and solving challenges
- Plan, design, implement, conduct, and analyze laboratory experimentation to advance scientific knowledge of drug substances or techniques to identify such substances
- Contribute to scientific literature and conferences through publication and presentation of research results
- Collaborate with Legal to ensure patent protection for drug products
- Build and enhance relationships with colleagues from Process Chemistry, Analytical, Quality, DMPK, and others as appropriate
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Qualifications
- PhD with 10+ years of extensive industry experience or in related scientific discipline, including experience working in cGMP environment, leading and managing teams within Formulations
- Deep understanding of the principles and practices of chemistry or pharmaceutical science; proven experience with the formulations of new chemical entities and the optimization of drug substance form selection
- Experience leading teams in support of drug discovery and non-clinical development
- Experience working cross functionally with greater CMC/Technical Operations team, Quality Assurance and Regulatory Affairs
- Knowledge of basic analytical skills required: HPLC, UV, dissolution, solid state characterization
- Proficient in writing technical reports and CMC regulatory documents
- This is an on-site role and the candidate selected is expected to be on-site for a minimum of 3 days per week
Salary pay range: $194,000 - $237,000. Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the service line and location where this position may be filled. Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
Job tags
Salary