Senior Scientist 1, Drug Product Development

Senior Scientist 1, Drug Product Development

Categories: CMC (MFG)

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.

Position Summary:

The Senior Scientist 1, Drug Product Development will support drug product development from preclinical through development and manage a CMC Formulation Lab. This job will report to Associate Director, Drug Product Development CMC. The Chemistry, Manufacturing and Controls (CMC) team is highly collaborative and operates with a global network of highly qualified Contract-Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs). This individual will be an integral part of the company's effort to discover and develop small molecule therapeutics for rare endocrine disorders. This is a unique opportunity to work with a proven and well-funded drug discovery and development company in the heart of San Diego's biotechnology community. This position will be located in San Diego.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Lead the development of phase-appropriate formulations for preclinical and early clinical stage drug candidates and perform pre-formulation evaluations, including physicochemical characterization, compatibility, and stability.

• Design formulations to support the transition of molecules from Discovery to clinical development stage.

• Represent CMC Formulation function and work collaboratively with cross-functional teams, including but not limited to Discovery, Toxicology, DMPK, in vivo Pharmacology.

• Work collaboratively with external partners for outsourced projects.

• Draft technical documents for process transfer to internal and external partners.

• Manage CMC formulation lab by 1) overseeing installation of new instrument and preventive maintenance of laboratory instruments; 2) coordinating instrument trainings; 3) preparing user guides or best practices for instrument for internal use; 4) identifying needs for additional capabilities.

• Support regulatory filings (INDs, IMPDs, NDAs, briefing packages and other regulatory dossier) as needed.

• Other duties as assigned.

Education and Experience:

Required:

• Ph.D. in pharmaceutics, pharmaceutical sciences, chemistry or related field, with a minimum of 5 years of relevant hands-on experience in pharmaceutical, biotech laboratory, or CDMOs. (Masters with 12 years of experience or Bachelors with 15 years of experience, may be considered).

• Extensive knowledge in designing phase appropriate formulations for preclinical and early clinical studies (i.e., IND-enabling).

• Direct work experience with instruments used in pre-formulation laboratory and in analytical techniques such as HPLC/UPLC, and solid-state characterization tools, including DSC, TGA, DVS, XRPD etc.

• Hands-on experience with laboratory scale equipment used for formulation and process development of early phase dosage forms, including solution, suspension, powder for reconstitution and powder in capsules.

• Knowledge of cGMP requirements and regulatory guidance (FDA, ICH).

• Excellent written and oral communication skills, including the drafting and reviewing technical documents and the ability to effectively and accurately present data to peers, management, and external partners.

• Excellent ability to work in a goal and team-oriented setting and handle competing priorities.

• Flexibility within a rapidly changing environment and high attention to detail.

• Well-developed organizational skills and the ability to thrive under pressure.

• Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint, MS Project).

Physical Demands and Work Environment:

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Laboratory Activities: (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.

Travel:

You may be required to travel for up to 10% of your time.

The Anticipated Base Salary Range: $120,000 - $150,000

In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.

Equal Opportunity Employer:

Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.

Vaccination requirement:

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

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