- Develop chemical processes for manufacturing drug substances
- Manage and mentor process chemists internally and at contract manufacturers (CMOs)
- Manage development activities for cGMP drug substance manufacturing of small molecule drugs at CMOs
- Contribute to the development of target drug substance profiles and specifications, setting goals and maintaining timelines for CMO manufacturing activities
- Ensure quality, economics, and adequate supply chain security for drug substances
- Contribute to identifying and facilitating purchase of custom raw materials and supplies needed for 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
- Coordinate production schedules based on preclinical and clinical development requirements
- Review proposals, negotiate prices, recommend suppliers, verify delivery, 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
- Ph.
- Strong synthetic organic chemistry knowledge and problem solving skills
- Strong understanding of solid state properties of small molecules
- 8+ years of experience in small molecule drug substance development
- Direct experience with management of CMOs
- 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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Cytokinetics, Incorporated South San Francisco, United StatesCytokinetics is a late-stage, specialty cardiovascular 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 cardiac muscle p ...
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Associate Director, Drug Substance Manufacturing
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Associate Director, Chemical Development/Drug Substance Manufacturing - South San Francisco, United States - Cytokinetics, Incorporated
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.
ResponsibilitiesWe 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.
QualificationsSalary pay range:
$178,000 - $218,000. 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:
Cytokinetics is an Equal Opportunity Employer
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