$217,710–$253,995 Per Year
Analysis Skills, Banking Services, Biology, CMOS, Cardiology, Cardiovascular, Chemical Processes, Chemistry, Clinical Support, Coaching, Communication Skills, Contract Manufacturing, Cross-Functional, Current Good Manufacturing Practice (cGMP), Disease, Documentation, Drug Development, Drug Manufacturing, Economics, GMP (Good Manufacturing Practices), Leadership, Manufacturing, Medical Products, Mentoring, Multitasking, Organic Chemistry, Organizational Skills, Performance Management, Pre-Clinical Development, Presentation/Verbal Skills, Problem Solving Skills, Process Development, Process Improvement, Process Management, Process Manufacturing, Production Schedule, Purchasing/Procurement, Quality Assurance, Record Keeping, Regulations, Regulatory Compliance, Regulatory Submissions, Requirements Management, Research & Development (R&D), Set Goals, Small Molecule Drugs, Small Molecules, Staff Development, Strategic Planning, Supply Chain, Talent Management, Team Player, Technical Leadership, Transportation Routing, Vendor/Supplier Selection, Willing to Travel, Writing Skills
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.
We are seeking a highly skilled and motivated Director with expertise in small molecule process development and manufacturing to join our CMC team. In this role, you will be responsible for the technical development of small molecule drug substances from IND-enabling studies through commercialization. You will play a key role in advancing our drug development programs by leading efforts in synthetic route design, process optimization, control strategy development, and scale-up and GMP manufacturing activities at external CDMO partners. You will serve on a cross-functional CMC team and develop a comprehensive CMC development plan that supports clinical development. This position offers an exciting opportunity to contribute to the development of novel therapeutics and to work in a dynamic and collaborative research environment. This position is integral to the advancement of Cytokinetics' growing portfolio of drug candidates.
In addition to technical leadership responsibilities, this role may have people leadership responsibilities, including coaching, mentoring, performance management, talent development, and fostering a collaborative, high-performing team environment.
Responsibilities:
- Lead and manage the development of chemical processes for manufacturing drug substances
- Manage and mentor process chemists internally and at contract manufacturers (CMOs)
- Provide coaching, mentorship, and development support to team members as applicable, fostering scientific excellence, collaboration, and continuous learning.
- Manage chemistry development activities for cGMP drug substance manufacturing of small molecule drugs at CMOs during pre-commercial periods
- Develop target drug substance profiles and specifications, set goals and maintain timelines for CMO manufacturing activities
- Ensure quality, economics, and adequate supply chain security for drug substances
- Identify and facilitate purchase of custom raw materials and supplies needed for clinical and developmental drug substance manufacturing under tight time constraints
- Develop and maintain good relationships and contracts with CMOs
- Visit, evaluate and audit contract sites for GMP manufacturing activities during clinical and development phases
- Coordinate production schedules based on preclinical and clinical development requirements
- Actively participate and support supplier assessment and selection processes including: review proposals, recommend suppliers verify delivery, when appropriate and maintain necessary records
- Work cross functionally with CMC analytical team and formulations team, QA and Regulatory teams
- Work collaboratively with partners for all drug substance related activities
- Compile documentation and draft CMC sections for regulatory submissions
- Support interdisciplinary working teams with recommendations, advice and action plans for drug substance related issues
- Represent the drug substance team in cross-functional working teams, and communicate drug substance related issues and information to groups within the company
- Act as CMC representative at cross functional meetings as required
Qualifications:
- Ph.D. in Chemistry
- Strong synthetic organic chemistry knowledge and problem solving skills
- Strong understanding of solid state properties of small molecules
- 12+ years of experience in small molecule drug substance development
- Direct experience with management of CMOs
- Prior people leadership experience, including coaching, mentoring, performance management, and employee development, is preferred
- 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
- Strong understanding of drug development process from R&D through commercialization
- Strong written and verbal communication skills
- Strong organizational skills and ability to effectively manage multiple priorities and projects
- Ability to travel domestically and internationally
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Pay Range:
In the U.S., the hiring pay range for fully qualified candidates is $217,710 - $253,995 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate''s geographic region, job-related knowledge, skills, and experience among other factors.
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.
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.
Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers
Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.
Here are some ways to check for authenticity:
We do not conduct job interviews through non-standard text messaging applications
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If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer