Manager/Senior Manager, Stability Management

 
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