Agios, in collaboration with MCPHS University, offers a unique fellowship program to promote the role of the Doctor of Pharmacy (PharmD) within the biopharmaceutical industry. A fellow gains extensive experiences through various practical activities in both industry and academic settings, which could enhance the potential for accelerated career development.
About Regulatory Affairs–Chemistry, Manufacturing, and Controls
Regulatory Affairs–Chemistry, Manufacturing, and Controls (RA–CMC) is a specific area within Regulatory Affairs that is responsible for providing regulatory strategy and leadership to support the CMC/quality modules of global regulatory filings as well as CMC-focused health authority interactions. The CMC/ quality modules include information on the development, manufacture, and testing of clinical and commercial active ingredients and drug products. The RA–CMC team oversees the planning and execution of all quality aspects of clinical trial applications ranging from Phase I through Phase 3 (i.e. INDs, Investigational Medicinal Product Dossiers, Quality Overall Summaries) as well as commercial marketing applications (i.e. NDAs, MAAs). This team collaborates with a diverse cross-functional team, including technical operations, quality affairs, supply chain, and clinical development, to assess the impact of quality/manufacturing changes, determine the appropriate regulatory filing strategy/timelines, and to prepare the appropriate amendments, supplements, and variations.
Fellowship Goals and Objectives
The goal of the Agios RA–CMC Fellowship Program is to give the fellow hands-on knowledge of US and Global regulatory affairs CMC, including an extensive understanding of the drug development process, CMC dossier planning and development, and competent authority interactions.
Developing a strong understanding of US and global CMC regulatory guidance and industry practice
Obtaining well-rounded knowledge of the process for planning, preparing, and submitting CMC dossiers
Cultivating strong communication and project management skills
Collaborating cross-functionally with various departments within the company as a partner in the product development process
As an integrated member of the RA–CMC team at Agios, the fellow will be provided with an array of invaluable opportunities across both the rare genetic disorders and oncology portfolios to gain real-life regulatory experience and further enhance their professional knowledge. Over the two years, the fellow will take on projects of increasing scope and responsibility while obtaining a deep comprehension of RA–CMC’s roles, responsibilities, and day-to-day tasks, as well as familiarize themselves with the complexities and cross-functional nature of the drug development process.
To be considered for an interview at Midyear, please register for both ASHP Midyear and PPS and then complete a fellowship application on the MCPHS Fluid Review application portal. Visit https://mcphs.fluidreview.com/
Please DO NOT request an interview within PPS. Our recruitment teams will contact qualified candidates via email to schedule interviews.
Before ASHP Midyear Clinical Meeting
Applicants must upload the following application materials to the online portal by December 2, 2019:
Letter of intent
Unofficial college transcript
Contact information of three references for their recommendations.
Incomplete applications WILL NOT be reviewed. ASHP Clinical Midyear Meeting interviews CANNOT be scheduled until these materials have been submitted. Please keep in mind that this is a competitive process and applicants are encouraged to complete their applications as soon as possible.
After ASHP Midyear Clinical Meeting
The three letters of recommendation must be submitted by the three provided contacts no later than December 16th
Top candidates will be invited for onsite interviews at Agios headquarters. Final candidates will be required to go through additional screening / onboarding as required by MCPHS University.
The MCPHS Biopharmaceutical Industry fellows will be selected on a nationally competitive basis, with interviews at the American Society of Health Systems Pharmacists (ASHP) Midyear meeting.
Applicants must have a Doctor of Pharmacy degree from an ACPE accredited college of pharmacy at the commencement of the program.
Candidates must have strong written and verbal communication skills and a strong interest in pursuing a career within the biopharmaceutical industry.
All candidates must have authorization to work in the United States throughout the duration of the one or two-year fellowship. No visa sponsorship will be provided.
Additional Salary Information: Fellows will receive a competitive stipend and benefit package, including comprehensive health insurance
About MCPHS University/Agios
Agios is a biopharmaceutical company passionately committed to applying our scientific leadership in the field of cellular metabolism to transform the lives of patients with cancer and rare genetic disorders. Metabolism is a complex biological process involving the uptake and assimilation of nutrients in cells to produce energy and facilitate many of the processes required for cellular division and growth. We believe that dysregulation of normal cellular metabolism plays a crucial role in many genetic diseases. We believe Agios is a first mover in using cellular metabolism, an unexploited area of biological research with disruptive potential, as a platform for developing potentially transformative medicines. We intend to apply our deep understanding of metabolism, coupled with our ability to create medicines that can inhibit or activate metabolic enzymes, to fundamentally change the way cancer and rare genetic disorders are treated.