Manager, Analytical Sciences - Commercial

Praxis Precision Medicines, Inc.; Northern (KY); Hybrid; USD 115,000 - 140,000; Full time

Job summary

Praxis Precision Medicines is seeking a Manager, Analytical Sciences - Commercial. This remote US role requires travel to the Boston area and 20-30% travel to CDMO sites for validation campaigns and inspections.

You will lead analytical strategy for the commercial portfolio, manage method transfer, validation, lifecycle management, and TE approvals with cross-functional teams to ensure regulatory readiness and data integrity.

Qualifications

• Bachelor’s degree in Chemistry or related discipline with 7+ years of analytical chemistry experience in a GMP-regulated environment.
• Experience supporting commercial small molecule drug substance and/or drug product programs; analytical development experience preferred.
• Strong knowledge of small molecule drug substances and oral dosage forms and regulatory requirements.

Responsibilities

• Execute analytical strategies for commercial products ensuring methods, specifications and control strategies remain compliant.
• Lead method transfer, validation, and lifecycle management activities with risk identification and resolution.
• Support analytical activities for PPQ, CPV, commercial manufacturing, and stability programs with data quality and regulatory compliance.
• Review and approve analytical documentation including protocols, reports, specifications, CoAs, and audit trails.
• Manage analytical activities at CDMOs ensuring timely, compliant deliverables for release, supply, and inspections.
• Lead or support OOS/OOT investigations, deviations, CAPAs with root cause analysis.
• Assess analytical risks from manufacturing and supply changes; ensure impurity controls and lifecycle strategies.
• Contribute to regulatory submissions, APR/PQRs, and health authority responses.
• Serve as analytical SME, partnering with Quality, Regulatory, Manufacturing, and CMC teams.

Skills

Analytical chemistry

GMP compliance

Method transfer

Validation

Data integrity

ALCOA+

cGMP knowledge

Regulatory submissions

Cross-functional collaboration

CDMOs management

Education

Bachelor’s degree in Chemistry or related discipline

Job description

Manager, Analytical Sciences - Commercial

United States - Remote

Location: This position may be performed remotely with travel to the Boston area as needed, and an expected 20-30% travel to CDMO sites, particularly during validation campaigns, critical investigations, and health authority inspections.

The Opportunity

Praxis is hiring a Manager, Analytical Sciences to play a key role in ensuring the analytical readiness and ongoing quality of Praxis’ commercial portfolio. You’ll own and support analytical strategy across commercial manufacturing, helping ensure testing is executed in accordance with regulatory commitments while advancing lifecycle management of approved products.

You’ll partner closely with CDMOs supporting small molecule drug substance and drug product manufacturing, with responsibility for analytical methods, control strategies, data integrity, inspection readiness, and continuity of supply. Success in this role will require strong scientific judgment, a hands-on approach, and the ability to identify risks early and work cross-functionally to develop practical solutions.

Primary Responsibilities

• Execute analytical strategies for commercial products, ensuring methods, specifications, and control strategies remain compliant and fit for purpose.
• Lead method transfer, validation, and lifecycle management activities, identifying risks and driving resolution.
• Support analytical activities for PPQ, CPV, commercial manufacturing, and stability programs, ensuring data quality and regulatory compliance.
• Review and approve analytical documentation, including protocols, reports, specifications, method validations, CoAs, raw data, chromatographic integrations, and audit trails.
• Manage analytical activities at CDMOs, ensuring compliant, timely deliverables that support product release, supply continuity, and inspection readiness, including on-site support during critical campaigns and inspections.
• Lead or support analytical investigations involving OOS/OOT results, deviations, and CAPAs, performing root cause analysis and supporting quality decisions.
• Assess analytical risks associated with manufacturing, supply chain, and process changes, ensuring appropriate impurity controls and lifecycle management strategies.
• Contribute to regulatory submissions, post-approval changes, Annual Product Reviews (APR/PQRs), and health authority responses.
• Serve as an analytical SME, partnering with Quality, Regulatory, Manufacturing, and CMC teams to support compliant commercial operations.

Qualifications and Key Success Factors

• Bachelor’s degree in Chemistry or related discipline with 7+ years of analytical chemistry experience in a GMP-regulated environment.
• Experience supporting commercial small molecule drug substance and/or drug product programs; analytical development experience preferred.
• Strong technical knowledge of small molecule drug substances and oral dosage forms, including solid oral and liquid/reconstituted products.
• Experience with analytical method transfer, validation, and lifecycle management in GMP environments.
• Ability to review analytical data, chromatographic integrations, and electronic audit trails in accordance with ALCOA+, 21 CFR Part 11, and EU GMP Annex 11 requirements.
• Experience supporting commercial analytical methods and control strategies, including post-approval changes and method improvements.
• Working knowledge of US and EU cGMP requirements and applicable ICH guidelines.
• Experience contributing to regulatory submissions and supporting health authority inspections preferred.
• Demonstrated ability to troubleshoot analytical testing issues and partner effectively with QC laboratories, CDMOs, and external service providers.
• 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.

$115,000 - $140,000 USD

Compensation & Benefits

At Praxis, we believe that taking care of our people (and

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Diversity, Equity & Inclusion

Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.