This is a totally remote position from a suitable home office which could be located anywhere in North America, 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.
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 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.
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, 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.
Reporting to the Senior Director, CMC the Associate Director, CMC Formulation Development will be responsible for overseeing the technical aspects of drug product development and manufacturing activities for MPBC. This position will also oversee contract manufacturers (CMOs) including scale-up, validation, launch, on-going manufacturing support, process improvements and troubleshooting during drug product manufacture. In addition, the candidate will be responsible for authoring and reviewing relevant chemistry, manufacturing and control (CMC) sections of worldwide regulatory documents.
Provides direction for development, scale-up, validation, and launch of the DP manufacturing with CMOs.
Designs process optimization activities to ensure manufacturing processes are robust and cost-effective.
Directs Quality-by-Design (QBD) work for drug product manufacturing.
Ensures adherence to project timelines.
Provides oversight of all documentation related to the production of the drug products including development, scale-up and validation protocols/reports, batch records, deviations, process excursions, SOPs, etc.
Interfaces with and provides direction and management of CMOs to ensure drug product operations are conducted in compliance with cGMP requirements.
Authors drug product sections of CMC modules in regulatory documents including IND, IMPD, NDA, MAA and other regulatory submissions.
Track and maintain all CMC regulatory related supporting documents and data.
Work cross-functionally within the department and across MPBC and MAPS Europe B.V. to plan and maintain CMC and submission timelines according to internal and regulatory requirements.
Communicate and collaborate with key players, internal and external staff.
Check in regularly with supervisor and complete assignments by agreed deadline.
Document processes and provide regular updates.
Proactively seek methods of improvement, streamlining workflows and building efficiencies in individual work and project outcomes.
This position requires:
Demonstrated drug product (DP) development track record with successful NDAs and/or ANDAs or patents.
Proven pharmaceutics knowledge and related scientific capabilities relevant to DP development.
Thorough knowledge of the overall drug development process.
Expert understanding of technology transfer, cGMPs, FDA, EU & ICH guidelines.
Demonstrated experience in managing and influencing diverse project activities with third party manufacturing facilities in different geographical locations.
3+ years small molecule DP Module 3 CMC writing as well as other relevant CMC content for regulatory submissions including INDs, NDAs or ANDAs.
BS/MS/PhD in Pharmacy, Pharmaceutical Sciences or a related field.
5+ years of experience in the pharmaceutical industry, working in Pharmaceutical R&D or drug product (DP) development or DP pilot plant/commercial manufacturing operations.
Experience in filing FDA submissions, specifically INDs & NDAs or ANDAs.
CMC regulatory submission experience, including CFR 21 and ICH M4Q(R1).
Project Management or supervisory skills desired.
Internal Number: N-19
About MAPS Public Benefit Corporation
MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS) a 501(c)(3) nonprofit. We are a Public Benefit Corporation with a virtual work environment, we are a disbursed workforce with colleagues all over the United States and Globally. We offer full time employment and benefits, in a dynamic remote work environment
driven by values that promote sustainability, accountability, and transparency.
Sustainability: We use profits to continue research to benefit society.
Accountability: We take our impact on society and the environment into consideration.
Transparency: We are required to report and share progress towards our impact on society.