Apply on Employer Site

Crinetics Pharmaceuticals · 3 months ago

Director, Analytical Development

San Diego, CA

Full-time

Onsite

Director/Executive

$182K/yr - $227K/yr

12+ years exp

Crinetics Pharmaceuticals is a pharmaceutical company based in San Diego, California, developing therapies for endocrine diseases. The Director, Analytical Development will lead analytical development activities for small molecule therapeutics, manage relationships with external collaborators, and ensure compliance with regulatory requirements.

BiotechnologyHealth CarePharmaceuticalTherapeutics

Responsibilities

Establish, direct, and monitor implementation of appropriate Tech Ops testing methodology and specifications for raw materials, intermediates, excipients, active pharmaceutical ingredients (APIs) and drug products (DPs), with focus on oral dosage

Lead analytical development activities of the assigned projects and deliver business results for CMC/Tech Ops Analytical

Develop departmental processes to achieve department and corporate goals

Focus on immediate and short-term (<2 year) strategic planning horizon

Work closely with external CRO/CDMOs collaborators to c advance method development, qualification, transfer, and validation for API and DP for advanced programs

Provide detailed review and approval for protocols, reports, and raw data for analytical method qualification/validation, release testing, and reference materials qualification

Review and approve analytical methods, specifications, change controls, deviations, investigations, out-of-trend and/or out-of-specification reports

Ensure consistent implementation of analytical methods and product specifications at CDMOs/contract laboratories

Work in close collaboration with and supports other members of the Tech Ops team responsible for API and DP development and support to management, as necessary

Identify, evaluate, select, and develop relationships while actively managing external parties (CROs, CMOs, RM suppliers, consultants, etc.). This includes writing, reviewing, and managing requests for proposals, statements of work, contracts, budgets and timelines, and oversight on due diligence efforts

Author and review CMC sections of regulatory filings (including INDs, IMPDs, NDAs, briefing packages, and other regulatory dossiers)

Author and/or review departmental related Standard Operating Procedures and guidelines, technical reports, specifications, corrective/preventative actions, change controls, investigations, and deviations to ensure compliance with cGMPs and company standards

Effectively work with RA and QA on quality system to ensure up-to-date procedures, adherence, and compliance of vendors with cGXP regulations

Participate as CMC/Tech Ops subject matter expert in quality audits

Identify and promote opportunities to streamline in-house CMC analytical development activities

Provide leadership, career management and personal development to direct reports

Recruit and develop top talent. Align team to needs of the business

Other projects (impurity identification and characterization, etc.) as deemed appropriate

Qualification

Analytical ChemistryAnalytical DevelopmentMethod DevelopmentRegulatory FilingsHPLCGCLC-MSQuality SystemsInterpersonal SkillsTeam CollaborationMentoringOrganizational Skills

Required

Bachelor's degree in Analytical Chemistry or related field with 12+ years of progressively responsible experience in analytical development in biopharmaceutical development, or an advanced degree (MS or PhD) with a minimum of 10 years of relevant technical and industry experience

A minimum of 8+ years in a supervisory role

Work experience in a biotech or pharma company (with a focus on small molecules in late phase of development) and extensive experience in oral solid dosage forms is desired

Experience in relationship management of Contract Research Organization and contract laboratories

Extensive technical experience in analytical testing, method development and phase appropriate qualification/validation, characterization, and support of stability programs for small molecule API and oral DPs

Proficient with techniques that include but are not limited to HPLC, GC, KF, IC, LC-MS, UV-Vis, XRPD, microbial

Proficient in at least two other areas of pharmaceutical development (e.g., solid state analysis, physical characterization, drug product dissolution)

Successful record of managing analytical activities and overcoming challenges

Experience in reviewing and analyzing release and stability data for trending, shelf-life and specification setting

Solid understanding of CGLP and CGMP requirements, compendia testing, ICH, FDA, and EMA guidelines with a focus on product development and manufacture, including stability requirements

Extensive knowledge of CGMP, quality systems and industry standards and thorough understanding of requirements for products in late phase of development

Excellent interpersonal and communication skills (written and oral). This includes the ability to effectively and accurately present data to peers, management, and external partners

Excellent ability to work both independently and in a matrix team environment, in a goal and team-oriented setting and handle competing priorities

Ability and interest in mentoring and/or managing others

Flexibility within a rapidly changing environment and high attention to detail

Well-developed organizational skills and detail oriented