Associate Director, Chemical Development (CMC)
About the job
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.
We are currently seeking an Associate Director, Chemical Development in our CMC department. The AD will help to find opportunities and activities that can enable the scale up of drug candidates for pre-clinical and clinical studies as well as supporting validation activities when progressing to late stage.
In this role, you will be responsible for the technical development, support, validation, and commercialization of drug substances using an external and internal network of providers. This position is integral to the advancement of Cytokinetics growing portfolio of drug candidates and technology programs and will lead and contribute to the development of chemical processes for manufacturing drug substances. The Associate Director will exert influence in driving timelines, objectives, and long-range goals to drive projects forward.
Responsibilities
- Manage and mentor process chemists internally and at contract manufacturers (CMOs)
- Run development activities for cGMP drug substance manufacturing of small molecule drugs at CMOs
- Develop target drug substance profiles and specifications, set goals, and maintain relationships and timelines for CMO manufacturing activities
- Collaborate and lead cross-functional teams, both internally and at CROs (contract research organizations) to develop robust, scalable, efficient, and safe chemical processes.
- Identify and facilitate purchase of custom raw materials and supplies needed for drug substance manufacturing under tight time constraints
- Frequent contact with internal and external managers and senior leaders concerning projects, operational decision and commitments
- Visit and evaluate contract sites for GMP manufacturing activities
- Coordinate production schedules based on preclinical and clinical development requirements
- Author requests for proposal, review proposals, negotiate prices, recommend suppliers, verify delivery, and maintain vital records
- Work cross functionally with multiple functions including CMC analytical team, formulations, QA, medicinal chemistry and Regulatory to provide mentorship and support for potential new development candidates
- Compile documentation and draft CMC sections for Regulatory submissions
- Act as subject matter authority for interactions with Regulatory agencies
- Strategic long-term planning for Cytokinetics drug development programs
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. in chemistry, plus 8+ years of validated experience in small molecule drug substance development
- Strong synthetic organic chemistry knowledge and problem-solving skills
- Strong understanding of solid state properties of small molecules
- In depth understanding and knowledge of industry practices in drug substance manufacturing and supply
- In depth knowledge of cGMP regulations and compliance
- Good understanding and knowledge of analytical methods and related issues
- Experience in writing CMC sections for Regulatory submissions
- Good understanding of drug development process from R&D through commercialization as well as drug development timelines
- Good written and verbal communication skills
- Good interpersonal skills and ability to effectively manage multiple priorities and projects
Salary pay range: $176,000 – $219,000. 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.
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.
Cytokinetics is an Equal Opportunity Employer