IMP Supply Manager

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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 IMP Supply Manager (ISM) will assist the CMC team in ensuring that clinical drug supplies are forecasted, manufactured (through third party vendors) and managed in line with program-wide timelines, strategy and in accordance with relevant Standard Operating Procedures (SOPs), the principles of appropriate GxPs, with a strong focus on GCP, and all other applicable regulations governing medicines for human use. The ISM must enjoy working in a small, entrepreneurial environment that is mission-driven, results-driven, and research-oriented. The ISM will assist in reviewing applicable regulatory guidelines, clinical supplies planning, management, inventory, distribution, timelines, and specifications documents creation and review including essential document filing. The ISM will become familiar with all aspects of drug development, GxP guidelines and related FDA/rest of world regulations, and will have the opportunity to work in a team environment under direction of the Clinical Supply Chain Manager. 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. Priority is placed on applicants based in the Eastern time zone. 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:

Drug Supply Management

  • Forecasting of Investigational Medicinal Product (IMP) supply needs in collaboration with Manager, Clinical Supply Chain and Clinical Operations
  • Assist with development of IMP manufacture, release, and clinical trial supply timelines
  • Coordination and management of packaging/labelling requirements for US and non-US clinical trials
  • Support inventory management across multiple vendors and depots
  • Manage IMP shipments to domestic/international clinical sites and third-party investigators according to current processes and associated SOPs/WIs
  • Manage Active Pharmaceutical Ingredient (API) shipments to domestic/international laboratories, vendors, and third-party investigators according to current processes and associated SOPs/WIs

Administrative Support

  • Support SOP creation, review, updates and formatting
  • Participate in team meetings and assist in preparation, calendaring and management of meeting minutes
  • Perform administrative tasks to support the CMC and Project Management members as needed

Ideal Candidate:

Seven or more years of relevant experience. Relevant experience includes scaling an organization, managing multiple teams, fundraising, moving controversial issues from the fringe to the mainstream, as well as familiarity with a mission-driven work environment rich in non-monetary rewards.

Vendor Management

  • Attendance at vendor project management calls and follow-up related to minutes, action items and decision logs, as applicable
  • Coordination of vendor documents review and approval with senior team members and external consultants as needed
  • Vendor contracts tracking and program/study budget/cost projections
  • Assist with vendor identification, SOW planning, review and development

Trial-Specific Support

  • Creation of study specific IMP related plans, logs and processes according to established SOPs and templates
  • Assist with maintaining clinical team training documents
  • Assist in the creation of IMP related study training materials
  • Distribute IMP clinical trial related materials to sites or clinical team members as appropriate
  • Maintain effective communication with other members of the drug development and clinical teams
  • Participate in team meetings and assist in preparation, calendaring and management of meeting minutes
  • Perform administrative tasks to support the CMC and Project Management members as needed
  • Oversight and filling of all study related IMP essential documents within the respective eTMFs

Minimum Requirements:

  • A scientific degree or relevant experience with a strong interest in drug development and clinical research. Bachelor’s degree preferred.
  • 5 years of experience in clinical research
  • Knowledge of applicable regulatory frameworks and experience with project management concepts and activities and willingness to stay abreast of development in the area of professional competence.

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. Includes full benefits package.

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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.