Programmatic Manager
Directive
Manager/Lead – Analytical Test and Validation
Harrow
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Lead and manage analytical testing and validation activities to support technology transfer of ophthalmic products to CMOs.
- Oversee the review, approval, and execution of analytical method development, qualification, validation, and transfer protocols and reports.
- Act as the primary analytical subject matter expert (SME) during technology transfer, scale-up, and validation activities.
- Partner with CMOs, Quality Control, Quality Assurance, MS&T, and Regulatory Affairs to ensure alignment on analytical requirements and deliverables.
- Review and provide technical input on tech transfer packages, analytical data, and regulatory submission documents.
- Troubleshoot analytical issues and provide scientifically sound solutions to ensure compliance, accuracy, and reproducibility.
- Monitor progress of analytical deliverables across multiple projects, ensuring timelines and quality standards are met.
- Develop and implement best practices, procedures, and continuous improvement initiatives for analytical testing and validation.
- Provide mentorship and guidance to team members, fostering professional growth and technical excellence.
- Ensure adherence to global regulatory standards, ICH guidelines, and company quality policies.
Requirements
- Bachelor’s or Master’s degree in chemistry, Pharmaceutical Sciences, or related field (PhD preferred).
- 8+ years of experience in analytical development, validation, and tech transfer within the pharmaceutical or biotech industry.
- Strong knowledge of cGMP, ICH, FDA, and EMA guidelines related to analytical validation and regulatory submissions.
- Proven experience working with CMOs and leading analytical method transfers.
- Strong project management, leadership, and cross-functional collaboration skills.
- Excellent problem-solving, communication, and technical writing abilities.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
analytical testingmethod developmentqualificationvalidationtechnology transfertroubleshootingcontinuous improvementtechnical writingproject managementanalytical validation
Soft skills
leadershipcross-functional collaborationproblem-solvingcommunicationmentorshipprofessional growthtechnical excellence
