Manager/Senior Manager, CMC Analytical

Location
San Diego (Sorrento Valley), California
Posted
Mar 01, 2018
Required Education
Doctorate/PHD/MD
Position Type
Full time

Crinetics Pharmaceuticals is seeking a highly motivated professional to lead all analytical activities for API and drug product, joining its growing and dynamic team.  This individual will be an integral part of the company’s effort to discovery and develop small molecule therapeutics for rare endocrine disorders and endocrine-related cancers.  This is a unique opportunity to work with a proven and well-funded drug discovery and development team in a small company environment in the heart of San Diego’s biotechnology community.

Responsibilities

  • Plan, direct and oversee all CMC analytical activities related to API preformulation, API and DP methods development and validation, and stability
  • Set clear outcomes/deliverables for projects and own them, staying accountable to the company management team
  • Provide budget, manage financials and forecast analytical expenditures (including expenditures with CROs, CMOs and consultants)
  • Forecast all CMC analytical related expenses (including expenditures with CROs, CMOs and consultants)
  • Prepare and review regulatory filings (including INDs, IMPDs, NDAs, briefing packages and other regulatory dossier) to enable an efficient drug development program
  • Author, review, and/or approve department related Standard Operating Procedures, analytical methods, technical reports, corrective/preventative actions, change controls, investigations, and deviations, to ensure compliance with cGMP’s and company standards
  • Attend and participate in meetings with the FDA or other regulatory bodies
  • Develop relationships with external parties (CROs, CMOs, RM suppliers, consultants, etc.) and actively manage and oversee these external parties.  Evaluate and recommend external parties for analytical needs in API and drug product development to senior management
  • Ensure compliance with GMP standards, with customers (internal and external), and other regulatory requirements
  • Stay current on industry trend, practices and regulatory guidances
  • Participate in internal audits, client audits, and regulatory inspections as required
  • Manage priorities and timelines while also creating value by devising new possibilities and practicing the best/most practical technologies using QbD and PAT where appropriate
  • Set high standards on deliverables while managing risks such that maximum benefit is achieved on projects/programs
  • Create new systems/policies and oversee these for compliance
  • Provide guidance/tutoring for administrative personnel and project teams as necessary
  • Provide direction/oversee EHS aspects and careful mitigate/manage risks
  • Understand cross-functional needs in analytical API and drug product development and accordingly provide appropriate support to management and guide them as necessary
  • Provide presentations and updates as necessary to senior management
  • Other tasks as assigned

Minimum Qualifications

  • A Ph.D. in analytical chemistry with at least 7 years of related technical and management experience OR a BS with 10 years of related experience
  • Previous industry experience is a biotech or pharma company is preferred
  • Prior experience working at CROs/CMOs in a leadership or management position is desired
  • Prior experience managing third parties, domestic and international external service providers, and consultants
  • A thorough understanding of analytical chemistry, solid form science and global stability requirements is desired
  • Excellent writing skills as they relate to preparation of analytical methods development/validation and transfer protocols and reports.  Preparation of regulatory documents is a must
  • Excellent interpersonal skills with strong oral/written communication and presentation skills
  • Excellent negotiation skills and a tactful approach that leads to high value on services obtained and outcomes achieved
  • Excellent problem-solving skills
  • A strong understanding of cGLP and cGMP requirements and ICH and regulatory guidances
  • Good judge of risks and a keen ability to analyze options and manage outcomes
  • Familiarity of Quality and Regulatory Affairs as applicable to CROs/CMOs compliance and regulatory filings
  • Well versed with the latest trend in analytical technologies and the outsourcing industry

About Crinetics

Crinetics Pharmaceuticals Inc. (www.crinetic.com) is a rare endocrine and endocrine-related cancer therapeutics company.  Crinetics’ benefit package includes health insurance, stock options, a 401K and paid time off, and the company provides a pet-friendly work environment.  To apply, please email CV with an optional cover letter to hr@crinetics.com.