CMC Project Manager

Location
92130, San Diego
Posted
Jul 20, 2018
Discipline
Science/R&D, Chemistry
Required Education
Bachelors Degree
Position Type
Full time

We currently seek a CMC Project Manager (PM), reporting to VP of Program Management, with proven experience in managing a broad set of Chemistry, Manufacturing and Control (CMC) activities. As a key member of our Development Team, the CMC PM will work collaboratively with development staff and consultants, CMOs, and regulators to drive the definition and execution of our CMC strategy. The CMC PM will provide development team support through all product development stages (Process and Analytical Development, Process Transfer, GMP Manufacturing and Testing, Process and Analytical Validation and Commercial Manufacturing) enabling project delivery in line with time, financial and quality requirements. Primary responsibilities for the position include:

  • Collaborate with Development Leaders and CMC technical consultants to define CMC strategy for our product development programs
  • Manage the translation of strategy into integrated CMC timelines and deliverables across all development projects and communicate the plan to all key stakeholders. This includes timelines for activities to support Process Development, Analytical Development, Process Transfer (to CMOs), Quality Control and Manufacturing (Drug Substance, Drug Product, labelling and packaging)
  • Manage CMC Sub-team deliverables, scope, timelines, and resources on project activities so the program remains within budget, on schedule, and within scope. Identify and analyze project risks and help to develop appropriate mitigation strategies
  • Organize and schedule CMC Sub-team meetings to review CMC plans, risks, deliverables, and action items
  • Coordinate and manage CMO activities (tech transfer and GMP manufacturing support), including scheduling meetings, facilitating and tracking the exchange of information, drafting meeting minutes and coordinating calendars
  • Evaluate third-party manufacturers working with Quality Assurance and Regulatory Affairs, assist in negotiating effective supply/technical agreements. Identify and manage contract analytical laboratory site(s) required to guide and support third party manufacturing relationships
  • Manage the process development, manufacture, release and stability testing, of drug substance and analytical activities, technical transfer, process and method development, optimization, qualification and validation of activities related to all manufacturing operations
  • Manage drug candidate supply chain activities by efficient manufacturing planning, maintenance of inventory and distribution of drug substance and drug product to support both nonclinical and clinical studies
  • Review and approve master and executed batch records from all manufacturing activities; analytical release testing, stability studies and investigations
  • Develop and maintain ownership of CMC project documentation
  • Develop and provide consistent project reporting to the CMC Sub-team and Development Team
  • Provide CMC input to the company’s annual operational plans and budgetary process
  • Work with the Regulatory Department to develop timelines to support CMC submissions (e.g., INDs, IMPDs) and to author relevant sections of regulatory documents, including Investigator’s Brochure, Pharmacy Manual, Study Protocols, IND filings, IMPD, and DMFs
  • Participate in product development project teams as CMC functional area representative Track proposals and invoices to insure alignment with approved CMC budget
  • Manage consultants, vendors, and CROs to meet agreed upon program timelines/budgets

QUALIFICATIONS AND REQUIRED SKILLS

  • Suitable candidates will possess a bachelor’s degree in a relevant scientific/engineering/life sciences discipline or Life Sciences and a minimum 10 years of relevant industry experience, including a minimum of 5+ years working in a CMC specific function related to small molecule drug substance process development/manufacture and/or analytical methodology development/validation, formulation/drug product development and manufacturing
  • Advanced degree in Pharmaceutics, Chemistry, Chemical Engineering and/or PMI or PMP certification desired
  • Experience in project management techniques and principles including: project planning, execution and tracking, risk identification, resource and financial project planning
  • Comprehensive understanding of the CMC development strategies across IND-NDA stages, with strong knowledge of current US and EU regulations and cGMPs and experience with CTD format and content for regulatory filings
  • Strong technical/analytical skills to identify and solve problems in a fast-paced environment
  • Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company, and externally with consultants, vendors, and contract organizations
  • Strong organizational skills to maintain a high level of efficiency, productivity, and setting priorities in order to complete assignments in a timely manner and within budget
  • Exhibits a high level of initiative, strong drive, and follow-through
  • High level of commitment, flexibility and strong planning, coordination, teamwork, communication and interpersonal skills
  • Proficiency with Microsoft Project, Word, Excel, and PowerPoint
  • International experience is a plus
  • Travel, as needed