CMC Specialist - Remote Position

CMC · New Jersey, New Jersey
Department CMC
Employment Type Full-Time
Minimum Experience Experienced

                                                                                                                 Join our team: change the world while working from home!

About MAPS Public Benefit Corporation (MAPS PBC):

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

 

More information about the organization is available at https://mapspublicbenefit.com.

 

MAPS PBC 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. 

 

We believe in diversity and inclusion of people of all backgrounds, genders, races, ethnicities, sexual orientations, educational backgrounds, arrest or conviction record, military and veteran status, religions, abilities, and perspectives. MAPS PBC values and seeks applicants who are people of color, queer, transgender, gender non-conforming, and gender fluid. MAPS PBC strives to continually improve upon the supportive, equitable and accessible work environment.

 

Why work for MAPS Public Benefit Corporation (MAPS PBC)?

MAPS PBC is a dispersed workforce that offers full-time employment in a dynamic remote work environment. This means our employees enjoy competitive salaries and benefits packages, as well as the comfort of working from their own homes. Through the conscious use of technology, we stay connected to our team members and work community while, at the same time, enjoying the freedom of a remote environment.

 

We are committed to conscious leadership and an inclusive team dynamic. Our culture is one of mutual respect, responsibility, and trust. Our employees’ health and happiness are priorities, and we treat our staff like people, not numbers on a spreadsheet.

 

MAPS PBC is at the forefront of changing the way mental health issues are treated and is committed to bringing dignity and access to overcoming mental health challenges through the conscious use of psychedelics. We believe we are changing the world, and we want you to be a part of it.

 

Position Summary:

MAPS PBC is seeking an enthusiastic, focused, and well-organized person to join our Chemistry, Manufacturing and Controls (CMC) department. The CMC Specialist assists the CMC team with document management, including writing, formatting, version control, change control/tracking, and essential document filing. Additionally, this role will assist in clinical supplies planning, management, inventory, distribution, timelines, and specifications documents creation and review.

 

These activities will support all functional areas covered by the CMC team which include: clinical and commercial CMC for regulatory submissions, IMP (Investigational Medicinal Product) supplies, IMP logistics, IMP project management and inventory, vendor management, nonclinical toxicology, randomization systems, inspection readiness support and NDA project management. 

 

This position works in line with program-wide timelines, including maintenance of those timelines, and in accordance with relevant Standard Operating Procedures (SOPs), the principles of appropriate GxPs.

 

This CMC specialist will become familiar with all aspects of drug development and GxP guidelines and will have the opportunity to work in a team environment. The ideal candidate must enjoy working in a small, entrepreneurial environment that is mission-driven, fast-paced, and results-focused.

 

Location:

Although we are a West Coast-based company we are looking for applicants in the East-Coast Time Zone. This is a fully 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 meetings. Certain home office expenses may be reimbursed. A work computer will be provided. 

 

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

 

Minimum requirements:

  • A bachelor’s degree preferably in science or a related field
  • 2 years of relevant experience or exposure to drug development or clinical research
  • Familiarity with GxP
  • Ability to use common software tools such as (previous experience a strong plus):  Microsoft Office 365 Applications (Word, Excel, PowerPoint, Outlook, SharePoint), Smartsheet, Zoom and      Asana

 

Position duties:

Administrative Support

  • Participate in team meetings and assist in preparation, calendaring and management of meeting minutes
  • File program, study and site level IMP and randomization related essential documents in the appropriate filing systems such as eTMFs
  • Manage filling system for all (program level non-eTMF) vendor CMC, nonclinical, and randomization documents
  • Support the formatting, finalization, and approval of SOPs and related forms
  • Perform administrative tasks to support the CMC team members as needed

 

Drug Supply Management

  • 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
  • Assist with IMP supplies, trial-specific documents formatting, finalization, and approval
  • Attend vendor project management calls and follow-up related to minutes, action items, and decision logs, as applicable

 

Trial-Specific Support

  • Create 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

Additional Competencies:

  • Able to work independently and within a team
  • Self-motivated individual who is able to prioritize and take initiative on his/her own
  • Able to make informed decisions based on guidance from manager and take responsibility for actions
  • Open and clear communicator with excellent written and verbal communication skills
  • Able to prioritize and work productively in a remote, virtual setting
  • Possess sound judgment, discretion, and the ability to understand the needs of others
  • Strong organizational skills with the ability to plan and coordinate tasks, while managing competing priorities and timelines
  • Abile to recognize potential obstacles, and deliver conscientious and precise work even when under pressure
  • Demonstrate a results-oriented approach, determination, responsibility, and accountability

 

FSLA Status:  Non-exempt (i.e. eligible for overtime)

 

Compensation:  Salary range disclosed upon request. Includes excellent benefits package.


 

 

 

 

 

 

 

 

 

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  • Location
    New Jersey, New Jersey
  • Department
    CMC
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced