Cytokinetics 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 performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
As our Senior Scientist I, you will be looked at as our SME within the CMC function for analytical development and play a critical role in our dynamic team, focusing on small molecule therapeutics. This position is instrumental in managing and collaborating with Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMO), with a focus on managing method transfer/qualification, overseeing release/stability testing, and reference standard qualification at CMO/CRO. These will have a direct impact on all Cytokinetics pipeline compound development and clinical programs.
Responsibilities
- Oversee and manage analytical activities in CROs and CMOs as a subject matter expert for Analytical Development function
- Work with contract manufacturers to develop, validate, and transfer methods or trouble shoot as needed
- Coordinate and oversee analytical testing for release and stability studies for drug substances and drug products to ensure compliance with quality standards
- Review analytical methods, validation protocols, reports, and analytical data (in-process, release, and stability data) packets
- Participate in the establishment and justification of all specifications for drug substances and drug products
- Provide analytical expertise for manufacturing and testing deviations, OOS/OOT investigations working in concert with Quality Assurance to ensure proper disposition of affected materials
- Manage the reference standard qualification and recertification
- Work closely with internal Quality Assurance (QA), Process Chemistry, and Drug Product groups to ensure seamless integration and alignment of analytical methods and product quality
- Maintain comprehensive documentation of all analytical test results and method validation activities to support regulatory and internal requirements
- Review/author internal or externally generated technical documents and analytical sections of INDs as needed
- Represents Analytical Development at interdepartmental meetings
Qualifications
- Master’s or Ph.D. in Chemistry, organic chemistry, Biochemistry, or a related field with 6+ years of relevant industrial experience in analytical development, with a strong emphasis on small molecules
- Expertise in HPLC, GC, FTIR, Vis/UV, mass spectroscopy, XRPD, PSD, KF, and other relevant analytical methodologies
- Proven ability to manage and collaborate with external partners like CROs and CMOs
- Effective written and verbal communication skills and interpersonal skills
- Extensive knowledge and understanding of current ICH guidelines, USP procedures, GMP guidelines, and related industry practices
- Strong problem-solving skills with sound technically driven decision-making ability
- Excellent scientific and business communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills
- Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems
- Ability to multi-task and thrive in a fast-paced innovative environment
- Experiences with Veeva or TrackWise is a plus
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.Salary Pay Range$150,000—$183,000 USDOur 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.
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
