Senior Manager, Analytical Development, CMC

The Opportunity

We are seeking an Analytical Scientist to help build our growing CMC team. The ideal candidate 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 mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position. Work is performed in a remote, work from home environment. The employee is regularly required to sit; use hands and fingers; reach with hands and arms; and talk and hear. The employee is occasionally required to stand, walk, and climb or balance. Movement through sites and laboratories may occasionally be required as employee may need to visit these environments. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Visual acuity is required to read and produce accurate materials. Use of keyboards and cellular devices

Compensation & Benefits

At Praxis, we’re proud to offer an exceptional benefits package that includes:

• 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans
• Bonus program structured to pay on a quarterly basis
• 401k plan with 100% match up to 6% of employee’s contribution (Traditional & Roth)
• Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much more
• Unlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefit
• Eligibility for equity awards and Employee Stock Purchase Plan (15% discount)

To round out this 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.