Director, Process Engineering (Drug Substance)

<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p>Crinetics Pharmaceuticals is a global, clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of the next generation of therapeutics for patients with endocrine and endocrine-rooted diseases. Founded by an innovative team of scientists with a track record of successful drug discovery and development, we’re fueled by collaboration, curiosity, and empathy. We have a prolific discovery engine and robust pipeline across preclinical and clinical development that are purposefully designed to meet the needs of patients, empowering them to live life beyond their condition. Join our team on our mission to improve patients’ lives and transform the treatment paradigm in areas of serious unmet need.</p><p></p><p><b>Position Summary:</b></p><p></p><p>The Director, Process Engineering – Drug Substance will be responsible for planning and executing drug substance development and manufacturing for Crinetics synthetic, small-molecule programs. This position will report to the Senior Director, Drug Substance CMC, and will provide leadership on process engineering issues as it relates to process optimization, scale-up/scale-down, manufacturing, and tech transfer. The position will support activities from pre-clinical through commercial launch.  As a member of the highly collaborative Pharmaceutical Development team at Crinetics, the Director, Process Engineering will be expected to coordinate work with both internal lab resources, as well as a global network of Contract Research and Contract Manufacturing Organizations.</p><p></p><p><b>Essential Job Functions and Responsibilities:</b></p><p>These may include but are not limited to:</p><p></p><ul><li>Plan, direct, and oversee activities related to drug substance process development from pre-clinical through validation and commercial launch.</li><li>Oversee and advise on scale-up activities from lab to plant and scale-down activities from plant to lab.</li><li>Evaluate, select, and actively manage external parties (CROs, CMOs, etc.) collaborating with Quality to ensure compliance with GMP regulations.</li><li>Manage priorities and timelines while also creating value by optimizing processes, incorporating Quality by Design (QbD) principles and practicing the best/most practical technologies.</li><li>Prepare drug substance development and manufacturing timelines, and set clear outcomes/deliverables for projects, staying accountable to the Pharmaceutical Development team and Executive Leadership.</li><li>Prepare and review regulatory filings (including INDs, IMPDs, NDAs, briefing packages or other regulatory dossiers).</li><li>Collaborate with other Pharmaceutical Development team members to author/review technical reports, SOPs, and policies.</li><li>Stay current on industry trends, practices, and regulatory guidance.</li><li>Mentor direct reports and team members (internal as well as external), assuring desired project outcomes while developing and providing opportunities for rising talent; provide regular feedback and coaching for their professional development.</li><li>Other duties as assigned.</li></ul><p></p><p></p><p><b>Education and Experience:</b></p><p><u>Required:</u></p><ul><li>Advanced degree (PhD/Masters) in chemical engineering, or a related discipline, is required with a minimum of 10 years of experience in the pharmaceutical or other related industry. Exceptional candidates without an advanced degree may be considered.</li><li>8 years in a supervisory role.</li><li>Hands-on working experience and in-depth understanding of GMP requirements and CMC regulatory requirements for small molecule drug substance manufacturing and related quality requirements. </li><li>Technical project leadership experience in early-stage and/or late-stage drug substance process development.</li><li>Experience leading and overseeing drug substance development programs.</li><li>Expertise in QBD principles and risk assessments (FMEA, HAZOP).</li><li>Demonstrated track record for developing and mentoring direct reports or junior team members.</li><li>First-hand experience in writing/assisting with CMC documents for regulatory submissions. </li><li>Excellent interpersonal and communication skills (written and oral). This includes the ability to effectively and accurately present data to peers, management, and external partners.</li></ul><p></p><p><u>Preferred:</u></p><ul><li>Experience utilizing unit operation modeling and process simulation tools for synthetic molecule development.</li><li>Preference will be given for candidates with DoE expertise.</li></ul><ul><li>Prior experience leading tech transfers to domestic and international CROs/CMOs.</li><li>API crystallization and particle engineering experience, including both dry and wet milling.</li></ul><p></p><p><b>Physical Demands and Work Environment:</b></p><p><u>Physical Activities:</u> 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.</p><p></p><p>Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents. Employees must be able to wear a respiratory protection and other personal protective equipment for certain tasks essential to the job function.</p><p></p><p><u>Laboratory Activities</u>: Chemical laboratory environment experience needed. Environmental health and safety requirements also apply.</p><p></p><p><b>Travel:</b></p><p>You may be required to travel for up to 20-35% of your time.</p><p></p><p><b>Equal Opportunity Employer: </b></p><p><span>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.</span></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b><u>Salary Range</u></b></p>The salary range for this position is: $186,000 - $232,000.<p style="text-align:left"><i>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.</i></p>