Back to jobs

Manager/Senior Manager, Stability Management

Cambridge, MA

 
The Opportunity:

In this role you’ll bring your stability management and technical leadership experience to design and execute Relay’s development programs. You’ll form close partnerships with our CMC development, clinical supply chain and regulatory teams. To be successful, you’ll utilize your strong communication and relationship building skills as you manage testing and stability deliverables through external services. This position reports to the Director of Analytical Development and Quality Control. 

Your Role: 

You’ll be capable of taking an active role in supporting new drug candidates by managing stability and testing activities for Relay’s development programs. Your responsibilities will include: 

  • Working with the Analytical Development team in methodologies to support testing of drug substances, drug products, intermediates, and reference standards etc. 
  • Working closely with collaboration stakeholders to ensure project needs are met. 
  • Identifying and overseeing CTL’s/CMO’s to ensure stability and product release goals are met. 
  • Performing QC data review/approval of test/raw data for release and stability analysis. 
  • Establishing a robust Stability program strategy in support of Relay’s early and later-stage programs. Managing data trending to support stability data assessments and establishment of product shelf-life. 
  • Participate in the development and revision of product specifications; provide scientific input and statistical analysis of results. 
  • Manage the stability studies via Labware system. 
  • Authoring pharmaceutical usage document (PSU) for shipping control 
  • Authoring and reviewing relevant sections of Regulatory Submissions for IND, IMPD, NDA, etc. and prepare responses to health authority inquiries and observations. 
  • Ensure compliance with stability requirements for CMC regulatory submissions. 
  • Support audits and inspection activities of CRO’s to ensure compliance with regulations.  

Your Background: 

This role is typically best suited for Bachelors’ or Masters’ level candidates with 5+ years of experience in analytical CMC area in pharmaceutical industry. Additionally, successful candidates will possess: 

  • Expert knowledge in ICH guidelines for expiry extension. 
  • Experience in preparation of IND/IMPD/NDA submissions 
  • Experience in statistical analysis of stability data trending 
  • Experience interacting with and managing external resources (CTO’s/CMO’s). 
  • Ability to exert influence diplomatically and have a positive impact inside and outside of the organization. 
  • Demonstrated interpersonal, organizational, negotiation and communication skills. 
  • Ability to solve problems, develop plans, prioritize and manage multiple projects, and advance to completion on time and in full. 
  • Full understanding of scientific principles and applicable GxPs, Quality, and pharmaceutical processes, safety, and data integrity. 
  • Prior experience with computer, lab systems and software such as (Excel, Power Point, Word, Share Point, JMP, GraphPad Prism and Veeva QualityDocs/RIM) 
  • Ability to work cross-functionally in a fast-paced team environment. 
  • Ability to travel domestically and internationally as needed

 

About Relay Therapeutics

Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process.  

Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you’re excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us! 

 

 

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Relay Therapeutics’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.