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South San Francisco, California, United States
Onsite
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 motivated Preformulation Pharmaceutical Scientist to join our Preclinical Research Sciences team. In this role, you will work closely with biologists, chemists, and pharmacokinetic scientists at the forefront of drug discovery.
You will be responsible for the preformulation assessment of small molecules and for the design and evaluation of formulations that enable non-clinical pharmacokinetic, pharmacology, and toxicology studies. You will also contribute directly to the design and selection of candidate drugs with the potential to become life-changing medicines, collaborating with other small-molecule formulation groups across the organization.
Main Duties and Responsibilities
Serve as the preformulation representative on drug discovery and early development project teams, communicating strategy, risks, and data to cross-functional partners.
Design and evaluate formulations for non-clinical PK, PK/PD, pharmacology, and toxicology studies, selecting vehicles and excipients that deliver the required exposure and stability.
Lead preformulation assessment of new chemical entities (NCEs), including solubility, solid-state stability, particle size and morphology, bio-relevant dissolution, and polymorphism.
Conduct salt, co-crystal, and solid-form screening to support solid-form selection and de-risk downstream development.
Apply solubility-enabling technologies, such as amorphous solid dispersions, lipid-based systems, nanosuspensions, and complexation, to poorly water-soluble compounds.
Develop and qualify HPLC/UPLC methods supporting formulation characterization, stability assessment, and dose formulation analysis, including concentration and homogeneity verification for GLP toxicology studies.
Plan and lead laboratory work in accordance with project timelines, and oversee formulation or analytical work placed with contract research organizations.
Contribute preformulation and formulation data to candidate selection decisions and to documentation supporting first-in-human studies.
Author technical reports and correspondence to a standard suitable for internal review, CMC handoff, and regulatory filings.
Monitor the scientific literature and proactively apply established and emerging approaches to project challenges.
Effectively communicate and collaborate with CMC Formulation Development to enable robust and reliable advancement of compounds from preclinical to clinical phases of development
Education and Experience
M.S. or Ph.D. in Pharmaceutical Sciences, Chemistry, or a related discipline.
M.S. with 7 or more years, or Ph.D. with 4 or more years, of relevant industry experience in preformulation and preclinical formulation development.
Hands-on experience formulating poorly water-soluble compounds in a discovery research setting to maximize exposure in animal studies.
Hands-on experience with HPLC/UPLC analysis and method development.
Hands-on experience with dose verification and with solubility assays in simulated gastric fluid (SGF) and biorelevant media (FaSSIF and FeSSIF), performed in accordance with USP methods.
Required Skills
Strong technical knowledge of physicochemical and solid-state properties and their relationship to drug product design and performance.
Practical experience selecting and developing solubility-enabling formulations.
Practical experience with analytical method development across chromatographic techniques, with working familiarity with mass spectrometry.
Ability to manage several projects concurrently, using initiative and creativity to meet agreed objectives and timelines.
Excellent written and oral communication skills, including the ability to present technical results to research and CMC audiences.
Preferred Skills
Knowledge of biopharmaceutics and pharmacokinetic principles.
Experience supporting GLP toxicology studies, including dose formulation analysis.
Experience overseeing formulation or analytical work at contract research organizations.
Demonstrated problem-solving ability and excellent practical laboratory skills.
Strong collaboration and networking skills, with the ability to engage colleagues in new initiatives.
Ability to deliver reliably under competing priorities and timelines.
#LI-ONSITE
Pay Range:
The expected salary range for this position based on the primary location of South San Francisco, CA is $135,000-$157,500. The base pay offered will take into account internal equity and may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Base salary is just one component of our competitive total compensation package, which includes equity in the form of stock options and/or restricted stock units, comprehensive health, dental, vision, life and disability insurance coverage, 401k retirement benefits with employer match, learning and wellness stipends, and paid time off. Note that benefits are subject to change and may vary based on jurisdiction of employment.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
We will never request personal information such as banking details until after an official offer has been accepted and verified
We will never request that you purchase equipment or other items when interviewing or hiring
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
