Director of CMC

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MAPS Public Benefit Corporation (MPBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics prioritizing public benefit above profit. Founded in 2014, MPBC is a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS) a 501(c)(3) nonprofit. More information about the organization is available at mapspublicbenefit.com.

MPBC is committed to the evolution of psychedelic healing modalities. We are building a diverse and inclusive workplace where we learn from each other. We value transparency, autonomy, experimentation, and kind, direct feedback. We welcome applicants who thrive in the midst of a growing organization that values science and healing.

MPBC advances equity and inclusion in the workplace by providing equal employment opportunity to support a work environment free from discrimination on the basis of race, religious creed, color, national origin, ancestry, physical disability, mental disability, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, military and veteran status, arrest or conviction record, and any other basis prohibited by law. The organization also provides reasonable accommodations for qualified applicants and employees with disabilities. This equal employment opportunity policy applies to all aspects of employment, including recruitment, selection, advancement, training, problem resolution, and separation from employment. Through this policy, MPBC strives to establish and maintain an equitable and accessible work environment that is supportive and free from discrimination.

Call for Candidates

MAPS PBC is seeking an enthusiastic, focused, and organized person to join our Chemistry, Manufacturing & Controls (CMC) and Project Management department. The Director of CMC will provide operational leadership for success across commercial CMC activities and will oversee and support clinical CMC including IMP supplies and logistics. The Director will ensure that projects and activities are conducted in a timely manner and in accordance with Standard Operating Procedures (SOPs) and the principles of applicable GxPs. They must be able to work under pressure at times to handle a wide variety of activities. The Director will be responsible for defining and managing budgets for external and internal costs associated with commercial and clinical CMC. Suitable candidates are able to work well in a fast environment and adept at organizing and managing lots of information virtually.

 

Location

This is a remote position from a suitable home office with a private and quiet area to work. Secure internet and reliable phone reception are required. This position requires frequent phone and internet video meetings. Certain home office expenses may be reimbursed. A work computer will be provided. The MAPS PBC headquarters office is located in Santa Cruz, CA. Occasional travel may be required.

 

Hours

Full time, 40 hours per week. Applicants must be available 40 hours a week, during normal business hours (9:00 AM – 6:00 PM Monday-Friday PST). The exact schedule may be arranged upon hire. Occasional weekend hours may be required with advance arrangement.

 

Position Duties

  • Vendor selection and oversight for commercial drug manufacture
  • Scientific oversight of vendor management for clinical drug manufacture with the Manager, Clinical Supply Chain
  • Manage inter-dependencies across functions, between CMC regulatory, regulatory, NDA project management to support execution of project plan(s) and major regulatory submissions
  • Facilitate team meetings and operational mechanisms to drive cross-functional communication, decision making, and successful execution of program plans and major regulatory submissions
  • Communicate effectively to team members and MPBC Leadership team through written, verbal and project summary updates, providing line of sight to key issues and accomplishments
  • Engagement of expert consultants as needed for review and input into technical documents including but not limited to related protocols, reports, and CMC submissions
  • Lead coordination of CMC submissions with regulatory department and Manager, CMC Regulatory
  • Support definition of clinical and commercial CMC strategy
  • Support IMP supplies and logistics strategy with support from IMP Supply Managers and Manager, Clinical Supply Chain
  • Work with Regulatory Affairs to ensure timelines are met and content is delivered for relevant regulatory submissions are defined and adhered to
  • Reports to the Project Manager weekly and participates in regular meetings on the project, department, and organizational level.

 

People Management

  • Oversee, train, and mentor CMC and IMP supplies staff
  • Support planning, monitoring and management of the workload of CMC IMP supplies staff
  • Lead and contribute to departmental and cross-functional improvement activities
  • Identifying competencies and skills required, selecting and recruiting staff, defining appraisal, skills, and pathways for potential career path development
  • Ensures that CMC IMP supplies staff works efficiently in matrix environment
  • Builds the team by proper communication and motivation as well as organizing regular meetings
  • Reviews project needs and allocates resources
  • Periodically assesses the performance of CMC and IMP supplies staff based on feedback from Directors and other relevant roles
  • Supports the Senior Leadership Team in analyzing key performance indicators, identifying root causes of poor performance and implementing corrective actions
  • Supports reviews of factors related to evaluation, development, and retention of the CMC and project management staff
  • Monitors and enforces compliance with systems, processes and policies and all applicable regulations
  • Leads by example, living and enforcing company values

 

Minimum Requirements

  • Bachelor’s of Science in scientific discipline, advanced degree preferred.
  • 8+ years’ experience in Pharmaceutical industry process and regulations in clinical and commercial CMC with significant exposure to global teams.
  • 5+ years of experience in program management/leadership of cross-functional teams with demonstrated ability to drive projects to completion.
  • Experience and training in GCP/ICH Guidelines and other applicable regulatory requirements.
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook) and project management applications.

 

Additional Competencies

  • Ability to review highly technical and detailed CMC documents
  • Communicate and collaborate with key players, internal and external staff
  • Check in regularly with manager and complete assignments by agreed deadline
  • Document process and provide regular updates
  • Proactively seek methods of improvement, of individual work and project outcomes
  • Proactively work to streamline workflows, build efficiency, security and user interface of various platforms
  • Ability to work independently and within a team with strong interpersonal skills
  • Open and clear communicator
  • Excellent written and verbal communication skills
  • Confident and influential approach
  • Self-motivating, able to prioritize and take initiative
  • Make informed decisions based on guidance from manager and take responsibility for actions
  • Possess sound judgment, discretion and be detail orientated
  • Able to lead, motivate and understand the needs of others
  • Strong organizational skills with attention to details and timelines
  • Able to work quickly in a remote virtual setting
  • Computer skills, facility with word-processing and spreadsheet applications
  • Coordination and planning of tasks and time management
  • Recognize potential obstacles and work within set timelines
  • Conscientious and precise delivery of work even when under pressure
  • Be proactive in problem solving
  • Ability to use the following tools with some training (previous experience a plus): Microsoft Office 365 Applications (Word, Excel, PowerPoint, Outlook, SharePoint), Smartsheet, Zoom and Asana

 

Compensation

This position is exempt from overtime. Salaried compensation commensurate with experience, range available upon request.

Interested and qualified candidates are encouraged to send their CV and cover letter to jobs@mapsbcorp.com

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MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS is a 501(c)(3) non-profit research and educational organization.