Fellows will receive a competitive stipend and benefit package, including comprehensive health insurance
Employer will assist with relocation costs.
Internal Number: 2022 General Job Posting
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 GMP – Quality Assurance
GMP-Quality Assurance is a specific function within quality assurance responsible for manufacturing oversight, lot release and vendor oversight for the CMC quality aspects of pharmaceutical clinical development programs. The Fellow will work with the GMP-QA team in support of lot release of investigational products Phase I through Phase 3. This team collaborates with a diverse cross-functional team, including CMC (chemistry and manufacturing controls), analytical development, quality systems-QA, quality control-QA, regulatory affairs and clinical supply chain to ensure lots are released according to approved specifications to meet supply chain timelines.
GMP – Quality Assurance Fellowship Goals and Objectives
The fellow will gain hands-on knowledge of GMP-quality assurance activities within the Technical Operations organization and gain an extensive understanding of the drug development process. Objectives include: • Develop end-to-end quality oversight knowledge primarily in the clinical space. • Cultivate strong communication, leadership, and project management/organization skills • Collaborate cross-functionally with various departments within the company as a partner in the drug development process • Understand the requirements for supplying drug for phase 1-3 studies, US only and global studies, blinded studies, Investigator Sponsored Trials (IST), and Expanded Access Programs (EAP) • Recognize common quality challenges and act proactively to ensure product quality is met throughout the clinical trial process • Effectively coordinate activities and communication with vendors within an external manufacturing network
GMP – Quality Assurance Fellowship Program Design
The GMP-QA Fellowship follows a rotational development plan with the first year focused on the clinical packaging and labeling (P&L) QA space, specific to release of finished goods in support of clinical trials. End of year 1 and year 2 may expand into quality oversight and release of commercial finished goods as well as clinical drug product and drug substance. The fellow will gain hands-on GMP-Quality Assurance experiences to further enhance their professional knowledge. Assuming increasing responsibility over the two years, the fellow will obtain a deep comprehension of GMP-QA’s role, responsibilities, and dayto-day tasks as part of a cross-functional team to support global clinical and commercial drug development.
To be considered for an interview, please complete a fellowship application on the MCPHS SMApply application portal. Visit https://mcphs.smapply.io/
Please DO NOT request an interview within PPS. Our recruitment teams will contact qualified candidates via email to schedule interviews.
The MCPHS application portal will open up on October 3, 2022. Applicants must upload the following application materials to the online portal by November 11, 2022:
Letter of intent
Unofficial college transcript
Contact information for three references. References will receive an electronic recommendation form to complete separately.
Incomplete applications WILL NOT be reviewed. 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.
Three recommendation evaluation forms must be submitted no later than December 1, 2022, via the online portal. This is NOT a letter of recommendation but an online form that the reference will need to complete.
Rolling Application Review & Interviews
All submitted applications will be reviewed on a rolling basis. Interviews will also be offered on a rolling basis and opportunities are limited. Priority will be given to those applicants who apply early, well in advance of the deadline.
Rolling interviews will begin mid-October with pre-screens and a mixture of interview rounds, and will conclude in December at the end of the ASHP Midyear Clinical Meeting. Candidates will be notified if selected for an interview.
ASHP Midyear & Onsite Interviews
The fellowship program will be conducting in-person interviews at the ASHP Midyear Clinical Meeting in Las Vegas. Applicants are strongly encouraged to attend. Candidates attending in-person will not be able to interview without registering for both ASHP and PPS. Please refer to the ASHP & PPS website for registration details.
Top candidates may be invited for interviews at the sponsoring company’s location pending COVID – 19 restrictions.
Recognizing that the choice of a Post-Doctoral Industry Fellowship is an important decision, MCPHS in conjunction with the Academic Industry Fellowship Alliance (AIFA), has agreed to extend offers for Fellowships no earlier than December 7, 2022.
Final candidates will be required to go through additional screening / onboarding as required by MCPHS.
The MCPHS Biopharmaceutical Industry fellows will be selected on a nationally competitive basis. 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 (i.e., TN, H-1B, STEM OPT, etc.).
Agios is a biopharmaceutical company passionately committed to applying scientific leadership in the field of cellular metabolism to transform the lives of patients with genetically defined diseases. 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. Agios believes 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. Agios intends to apply a deep understanding of metabolism, coupled with the ability to create medicines that can inhibit or activate metabolic enzymes, to fundamentally change the way genetically defined diseases are treated.
Agios has a dynamic culture, which supports our employees’ unwavering commitment to science and patients. World-class founding and leadership teams with the experience and track record to provide the insights required to develop groundbreaking medicines lead a... group of exceptional employees.
We pride ourselves on fostering an interconnected environment that encourages creative scientific collaboration across disciplines. Our unique culture, combined with the commitment and passion of our team, reflect our belief in an “other side of possible” approach to our challenges and our work.