Scientist II, Analytical Development

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 a Scientist II t, you will be responsible for leading analytical lab support for in-house R&D activities. You are also expected to interface with external partners on method validation/transfer and release/stability testing for outsourced programs. These will have a direct impact on all Cytokinetics pipeline compound development and clinical programs.

Responsibilities

• Carry out method development, optimization, and laboratory testing to support Analytical Development, Process Chemistry, Formulation Development, DMPK, Pharmacology and Medicinal Chemistry

• Coordinate trouble shooting, calibration, and maintenance of lab instruments

• Manage and deliver in-house lab support for standard qualification and retest

• Oversee and provide analytical support for API process R&D and formulation development as well as drug product manufacturing and work within cross-functional teams

• Contribute to analytical development strategy for multiple projects

• Act as our SME for analytical development function in various projects

• Select appropriate analytical techniques and coach and/or manage contract lab counter parts to perform analytical method development/validation/transfer to support development and manufacture of API and drug product

• Review data from contract partners (CDMOs and/or CROs/CTLs)

• Prepare, review, and/or approve analytical methods, CoAs, study/validation protocols/reports, and CMC regulatory submission documents

• Collaborate across different functional areas such as DMPK, Research, Pharmacology, Toxicology, Pharmaceutical Development, Project Management, QA and Regulatory

Qualifications

• PhD with 2+ years relevant hands-on experience

• Must have hands-on experience with various modern analytical instruments applied to pharmaceutical analysis

• Experience leading analytical development activities for small molecule drug development

• Experience in managing projects at CROs/CDMOs and in-house projects desirable

• Work experience and knowledge of regulatory submissions (IND, IMPD, and/or NDA) desirable

• Effective written and verbal communication skills, interpersonal, collaboration, and planning skills

• Extensive knowledge and understanding of current ICH guidelines, cGMP guidelines, and related industry practices

• Strong problem-solving skills with sound technically driven decision-making ability

• 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

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

$139,000-$169,000 USD

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.

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer