Senior Manager, Analytical Development
Harmony Biosciences
5 hours ago
On-site
Plymouth Meeting, PA
Clinical Research and Development
Responsibilities:
- Serve as an analytical Subject Matter Expert (SME) for clinical and development programs, including drug substance and drug product development and manufacturing at contractor sites.
- Lead and support analytical development at multiple contractor sites: analytical method development, improvements, product characterization, and comparability assessments for early and late-stage programs.
- Provide technical oversight of Contract Organizations (COs), including:
- Act as technical resource for drug substance/drug product with emphasis on analytical chemistry and methodologies.
- Lead method development, improvement, and method validation.
- Manage laboratory deviations/investigations to timely closure with close collaboration with Quality.
- Oversee/co-manage release testing and stability programs with Quality Assurance.
- Ensure COs meet Harmony business objectives, quality, and compliance standards.
- Maintain lifecycle product documentation/data files (protocols, reports, SOPs, certificates, etc.).
- Coordinate analytical deliverables with Project Manager and CMOs/CROs; apply Quality by Design (QBD) and Design of Experiments (DoE).
- Trend/analyze/stats interpret stability data; identify degradation pathways/variability drivers; establish shelf-life projections.
- Lead analytical technology transfers; prepare/review dossiers for regulatory filings; support budget/cost savings initiatives.
Qualifications:
- BS in Analytical Chemistry (or related) + 8+ years; MS + 5+ years; or PhD + 2+ years.
- Technical proficiency in dissolution testing, chromatography (e.g., HPLC, GC), spectroscopy (e.g., UV-Vis, NMR/NMRF, MS) with method robustness and qualification/validation requirements; CMO experience a plus.
- Experience with pharmaceutical analytical development; troubleshooting during audits/vendor inspections.
- Experience developing/transferring methods from R&D to commercial.
- Knowledge of FDA/ICH regulations and regulatory submissions.
- cGMP mastery (ICH/USP/ISO); laboratory techniques/procedures.
- Strong computer, organizational, and analytical skills.
Benefits:
- Medical, Vision and Dental (first of month after start)
- Paid time off and company holidays
- Company-paid Disability and Life Insurance
- 401(k)
- Paid Parental leave
- ESPP
- Company-sponsored wellness programs
- Professional development
Application instructions:
- Not specified in provided text.
- Serve as an analytical Subject Matter Expert (SME) for clinical and development programs, including drug substance and drug product development and manufacturing at contractor sites.
- Lead and support analytical development at multiple contractor sites: analytical method development, improvements, product characterization, and comparability assessments for early and late-stage programs.
- Provide technical oversight of Contract Organizations (COs), including:
- Act as technical resource for drug substance/drug product with emphasis on analytical chemistry and methodologies.
- Lead method development, improvement, and method validation.
- Manage laboratory deviations/investigations to timely closure with close collaboration with Quality.
- Oversee/co-manage release testing and stability programs with Quality Assurance.
- Ensure COs meet Harmony business objectives, quality, and compliance standards.
- Maintain lifecycle product documentation/data files (protocols, reports, SOPs, certificates, etc.).
- Coordinate analytical deliverables with Project Manager and CMOs/CROs; apply Quality by Design (QBD) and Design of Experiments (DoE).
- Trend/analyze/stats interpret stability data; identify degradation pathways/variability drivers; establish shelf-life projections.
- Lead analytical technology transfers; prepare/review dossiers for regulatory filings; support budget/cost savings initiatives.
Qualifications:
- BS in Analytical Chemistry (or related) + 8+ years; MS + 5+ years; or PhD + 2+ years.
- Technical proficiency in dissolution testing, chromatography (e.g., HPLC, GC), spectroscopy (e.g., UV-Vis, NMR/NMRF, MS) with method robustness and qualification/validation requirements; CMO experience a plus.
- Experience with pharmaceutical analytical development; troubleshooting during audits/vendor inspections.
- Experience developing/transferring methods from R&D to commercial.
- Knowledge of FDA/ICH regulations and regulatory submissions.
- cGMP mastery (ICH/USP/ISO); laboratory techniques/procedures.
- Strong computer, organizational, and analytical skills.
Benefits:
- Medical, Vision and Dental (first of month after start)
- Paid time off and company holidays
- Company-paid Disability and Life Insurance
- 401(k)
- Paid Parental leave
- ESPP
- Company-sponsored wellness programs
- Professional development
Application instructions:
- Not specified in provided text.