Compensation Overview

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