Associate Director, CMC Formulation Development - Remote Position

CMC · Santa Cruz, California
Department CMC
Employment Type Full-Time
Minimum Experience Mid-level

About MAPS Public Benefit Corporation (MPBC):


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.


Position Summary:


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


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.


Location:


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.


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). The exact schedule may be arranged upon hire. Occasional weekend hours may be required with advance arrangement.


Minimum requirements:


  • 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


Position duties:


  • 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.


General Responsibilities:


  • 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


FLSA Status: Exempt / Salary


Compensation:  Competitive Salary range disclosed upon request. Includes full benefits package.


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 

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  • Location
    Santa Cruz, California
  • Department
    CMC
  • Employment Type
    Full-Time
  • Minimum Experience
    Mid-level