Associate Director Process Engineering

Job Title : Associate Director Process Engineering

Job Location : United States

Job Location Type : Remote

Job Contract Type : Fulltime

Job Seniority Level : MidSenior level

Crinetics is a pharmaceutical company based in San Diego California developing muchneeded therapies for people with endocrine diseases and endocrinerelated 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 patientcentric and teamoriented culture. Crinetics is known for its inclusive workplace culture. We are also a dogfriendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fullyintegrated endocrine company from discovery to patients. Join our team as we transform the lives of others.

Position Summary

The Associate Director Process Engineering will support mid to latestage manufacturing process development as part of the Manufacturing Science and Technology (MS&T) group within CMC. This job will report to the Director of MS&T and will manage activities related to drug substance and drug product process development validation and commercial manufacture. This individual will be an integral part of the company’s effort to develop and commercialize small molecule therapeutics for rare endocrine disorders and endocrinerelated tumors. This is a unique opportunity to work with a proven and wellfunded drug discovery and development team in a small company environment in the heart of San Diego’s biotechnology community.

Essential Job Functions And Responsibilities

These may include but are not limited to :

• Support efficient development of high quality and robust manufacturing processes using sound scientific and engineering tools to design scaleup characterize and optimize manufacturing processes.
• Plan direct and oversee process development manufacturing and validation activities at contract development and manufacturing sites (CDMOs).
• Develop relationships with external parties (CROs CDMOs RM suppliers consultants etc.) and actively manage and oversee these external parties. Partner with drug substance and drug product teams to evaluate and select external parties for development and manufacturing.
• Manage priorities timelines and resources while also creating value by employing the best / most practical technologies models and simulation tools to enable efficient process characterization and optimization.
• Provide support for drug substance and drug product groups.
• Coordinate with CMC Drug Substance Development Drug Product Development and Analytical to build CMC timelines aligned with overall project timelines.
• Prepare development and manufacturing timelines and set clear deliverables for projects.
• Prepare and review request for proposal and statement of work as well as associated budget.
• Provide budget manage financials and forecast resource expenditures including expenditures with CDMOs and consultants.
• Evaluate relevant process and analytical data monitor stability data and prepare contingency plans.
• Prepare and review regulatory filings (including IBs INDs IMPDs NDAs MAAs briefing packages and other regulatory dossiers).
• Author and review department related Standard Operating Procedures technical reports specifications corrective / preventative actions change controls investigations and deviations to ensure compliance with cGMP’s and company standards.
• Collaborate with other members of CMC (Analytical Drug Product Drug Substance) to develop common valueadded procedures.
• Stay current on industry trends practices and regulatory guidance.
• Provide presentations and updates as necessary to multidisciplinary development teams and as necessary to management.
• Other duties as assigned.

Required

Education and Experience :

Technical Knowledge Required

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 20 lbs. may be required. The noise level in the work environment is usually 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 environments experience needed. Environmental health and safety requirements also apply.

Travel

Travel may be required up to 15% of your time.

The Anticipated Base Salary Range : $138000$192000

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 topnotch 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 multistate 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 COVID19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a twodose vaccine or two weeks since a singledose 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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Salary : $138,000 - $192,000