Director, Pharmaceutical Technologies and Manufacturing

Crinetics Pharmaceuticals • Headquarters, KY

1d

About The Position

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. Position Summary: 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.

Requirements

• 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.
• 8 years in a supervisory role.
• 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.
• Technical project leadership experience in early-stage and/or late-stage drug substance process development.
• Experience leading and overseeing drug substance development programs.
• Expertise in QBD principles and risk assessments (FMEA, HAZOP).
• Demonstrated track record for developing and mentoring direct reports or junior team members.
• First-hand experience in writing/assisting with CMC documents for regulatory submissions.
• Excellent interpersonal and communication skills (written and oral). This includes the ability to effectively and accurately present data to peers, management, and external partners.

Nice To Haves

• Experience utilizing unit operation modeling and process simulation tools for synthetic molecule development.
• Preference will be given for candidates with DoE expertise.
• Prior experience leading tech transfers to domestic and international CROs/CMOs.
• API crystallization and particle engineering experience, including both dry and wet milling.

Responsibilities

• Plan, direct, and oversee activities related to drug substance process development from pre-clinical through validation and commercial launch.
• Oversee and advise on scale-up activities from lab to plant and scale-down activities from plant to lab.
• Evaluate, select, and actively manage external parties (CROs, CMOs, etc.) collaborating with Quality to ensure compliance with GMP regulations.
• Manage priorities and timelines while also creating value by optimizing processes, incorporating Quality by Design (QbD) principles and practicing the best/most practical technologies.
• Prepare drug substance development and manufacturing timelines, and set clear outcomes/deliverables for projects, staying accountable to the Pharmaceutical Development team and Executive Leadership.
• Prepare and review regulatory filings (including INDs, IMPDs, NDAs, briefing packages or other regulatory dossiers).
• Collaborate with other Pharmaceutical Development team members to author/review technical reports, SOPs, and policies.
• Stay current on industry trends, practices, and regulatory guidance.
• 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.
• Other duties as assigned.

Benefits

• discretionary annual target bonus
• stock options
• ESPP
• 401k match
• 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
• winter company shutdown

What This Job Offers

• Job Type: Full-time
• Career Level: Director