Senior Manager, Analytical Development

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

The Opportunity

The ideal candidate for this role is experienced in working closely with Contract Development and Manufacturing Organizations (CDMOs) that provide small molecule drug substance and drug product services to the pharmaceutical industry.  Working closely with Praxis’ CDMO network, the individual will use his or her knowledge of analytical method development, qualification, validation, and testing to support analytical projects across the portfolio.  Strong collaboration with Drug Substance/Drug Product scientists, engineers, Quality and manufacturing will be needed to ensure our products and processes are efficient and well-controlled. 

Primary Responsibilities

• Involved in supporting analytical deliverables of the CMC programs while working in conjunction with CMC team members and functional leads.  This includes management of analytical testing in our external network, especially as it relates to GMP drug substances and drug products and may include review of raw data, calculations, method validation documents, and stability reports; authoring analytical methods, CoAs, and reports; documenting, implementing, and monitoring change controls.   
• Ensuring that analytical documentation (protocols, reports, methods, COAs, change controls, etc.) are added contemporaneously to Praxis’ document management system  
• Oversight and coordination of CMC stability and reference standard programs.
• Direct monitoring of our external network providers that execute Analytical Development activities to ensure deliverables and continuously improve efficiency.   
• Supporting the design and development of phase-appropriate quality control strategies, specifications, and stability studies for drug substance and drug product.   
• Contribute to the overall CMC team in terms of execution.
• Collaborate with other functions of Praxis CMC to establish the technical and business practices of the team.

Qualifications and Key Success Factors

• Bachelor’s degree in Analytical Chemistry or related discipline with 10+ years of industry experience; Master’s degree or equivalent a plus.   
• Industry experience in Analytical Development specifically for small molecule drug substance as well as solid and liquid oral drug products (e.g., capsules, tablets, oral suspensions) is required   
• Strong attention to detail along with the ability to perform meticulous data review and data transcription review  
• Strong knowledge of US and EU cGMP requirements and best practices relating to drug substances and drug products  
• Ability to interpret and implement, as appropriate, compendia-based testing requirements for drug substances and drug products   
• Involvement in reference standard management and stability oversight  
• Experience with CMC development and support across all phases of drug development from initial regulatory filings through registration, validation and launch preferred   
• Experience in support of late stage / commercial products including product monitoring, improvement and issue resolution preferred   
• Demonstrated success in building and maintaining productive partnerships with CDMO partners and associated service providers to ensure the company’s objectives are achieved   
• Fluid and conversant with GMP and quality control   
• Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment.   
• Excellent interpersonal and communication skills, with the ability to develop important relationships that include trust and encourage diversity in all its forms.   
• Highly organized and detail-oriented with a passion to deliver quality results.  
• 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.