Manager, Analytical Sciences – Commercial

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $115k - $140k / year

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 20%

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Praxis

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2002

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Praxis is a company dedicated to connecting patients with meaningful clinical trial opportunities. With a focus on creating customized recruitment programs, Praxis utilizes a variety of specialized tools and extensive experience across various therapeutic areas to ensure they reach the right patients worldwide. Established in 2002, the company emphasizes the importance of patient engagement and utilizes sophisticated data insights to enhance the patient journey in clinical research.

📋 Description

• 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 • 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 supporting product release, supply continuity, and inspection readiness • Provide 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 • 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

🎯 Requirements

• Bachelor’s degree in Chemistry or related discipline • 7+ years of analytical chemistry experience in a GMP-regulated environment • Experience supporting commercial small molecule drug substance and/or drug product programs • 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 • Ability to troubleshoot analytical testing issues and partner with QC laboratories, CDMOs, and external service providers • Regular use of a computer, devices or other office equipment; clear communication; occasional movement; comfort with screen work, basic hand coordination, and focus

🏖️ Benefits

• 99% of the premium paid for medical, dental and vision plans • Company-paid life insurance, AD&D, disability benefits, and voluntary plans • Dollar-for-dollar 401(k) matching up to 6% on eligible contributions • Long-term stock incentives and ESPP • Discretionary quarterly bonus • Extremely flexible wellness benefit • Generous PTO • Paid holidays and company-wide shutdowns