Manager/Senior Manager, Analytical Operations

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity
We are seeking a Manager/Senior Manager to support and strengthen our growing CMC team. The ideal candidate will leverage previous laboratory-based experience to provide operational oversight of analytical testing and stability programs in collaboration with Contract Development and Manufacturing Organizations (CDMOs) that provide small molecule drug substance and drug product services to the pharmaceutical industry.  This role is critical to ensure that the Praxis analytical testing network is robust and operates at peak performance.  In addition, you will be responsible for overseeing the execution and lifecycle management (planning, set-up, and execution) of stability studies across Praxis’ development portfolio, ensuring compliance with ICH guidelines and regulatory expectations.

The role requires close coordination with CDMOs, internal Analytical Development, Drug Substance and Drug Product teams, CMC Outsourcing, Quality Assurance, Regulatory CMC, and Manufacturing functions to ensure timely generation and interpretation of analytical testing and stability data that support product shelf-life, storage, and regulatory submissions. 

Primary Responsibilities

• Collaborate with and support stakeholders within Analytical Development, Regulatory CMC, and Quality Assurance to ensure alignment on stability strategies and compliance with ICH guidelines.
• Ensure that analytical documentation (protocols, reports, change controls, etc.) are added contemporaneously to Praxis’ document management system.
• Contribute to regulatory filings (e.g., IND, IMPD, NDA) by preparing stability summaries and providing supporting information.
• Collaborate with other functions of Praxis CMC to execute the technical and business practices of the team.
• Lead the establishment, execution, and management of stability studies internally and at CDMO partners for drug substance and drug products across all development phases, ensuring alignment with regulatory and project timelines.
• Monitoring CDMO performance with respect to agreed timelines for providing stability protocols and reports and establishing metrics, as needed
• Review of raw data, calculations, stability protocols, and stability summary reports in direct support of the Analytical Development Project Leads.
• Perform trend analysis of stability data to be used in shelf-life assessment.
• Ensure timely data review to support OOT/OOS investigations and implementation of corrective actions related to stability studies.
• Monitor the execution of our reference standard lifecycle management, including qualification, requalification, inventory, and expiry tracking in coordination with external testing sites.

Qualifications and Key Success Factors

• Bachelor’s degree in Analytical Chemistry or a related discipline with at least 7 years of relevant industry experience in a GMP-regulated environment; advanced degree a plus but not required.
• Hands-on experience supporting stability and reference standard programs for small molecule drug substances and oral drug products (e.g., tablets, capsules, suspensions), including sample tracking, data trending, and documentation.
• Strong, working knowledge of stability study tracking software, such as Smartsheet, to monitor stability studies and evaluate CDMO performance.
• Working knowledge of US and EU cGMP requirements, ICH guidelines and compendial standards (e.g., USP, EP) applicable to stability studies and reference standards.
• Demonstrated success in building and maintaining productive partnerships with CDMO partners and associated service providers to ensure the company’s objectives are achieved.
• Strong communication skills and the ability to work effectively with cross-functional teams including Analytical Development, Quality Assurance, and Regulatory Affairs.
• Ability to support investigations and trending activities, including compilation of stability data tables, graphs, and summaries for internal and regulatory use.
• Strong attention to detail along with the ability to perform meticulous data review and data transcription review.
• Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment.
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.