Director, Pharmaceutical Analytical Sciences
Merck
5 hours ago
On-site
Rahway, NJ
Operations
Position Overview:
- Lead Pharmaceutical Analytical Sciences (PAS) strategy and operations for analytical methods supporting small-molecule clinical drug substance and drug product development (characterize, release, stability).
- Partner with process/formulation, CMC/Regulatory, Quality, and manufacturing/commercial teams to inform control strategy and support regulatory filings with scientifically sound, compliant approaches.
Required Leadership Skills:
- Set clear direction and priorities; lead with a quality mindset and compliance/integrity.
- Build inclusive, high-performing teams through coaching and development.
- Collaborate cross-functionally, influencing using data and scientific rationale; drive continuous improvement and proactive risk management.
Responsibilities:
- Lead analytical methodologies/platforms for drug substance/drug product development.
- Use project/portfolio management to deliver results on timelines.
- Review/approve data packages for scientific rigor and compliance.
- Represent the lab during internal/external audits and drive timely follow-up.
- Develop/review/maintain SOPs and controlled documents; operate within Quality Systems.
- Recruit, onboard, coach, and retain staff; build talent pipeline and succession plans.
- Maintain working knowledge of GMPs, ICH, and relevant FDA/global guidance.
Qualifications:
- BS/MS in Chemistry (or related) with 12+ years pharmaceutical drug substance and/or drug product development.
- PhD (or related) with 8+ years in the same.
Required:
- People leadership; strong scientific communication; creativity; cross-functional teamwork.
- Track record delivering results supporting development programs and regulatory filings.
Benefits/Compensation (if applicable):
- Annual bonus and long-term incentive (if applicable). Comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays/vacation, compassionate and sick days).
Application:
- Apply at https://jobs.merck.com/us/en (application deadline stated on posting). Requisition ID: R396510.
- Lead Pharmaceutical Analytical Sciences (PAS) strategy and operations for analytical methods supporting small-molecule clinical drug substance and drug product development (characterize, release, stability).
- Partner with process/formulation, CMC/Regulatory, Quality, and manufacturing/commercial teams to inform control strategy and support regulatory filings with scientifically sound, compliant approaches.
Required Leadership Skills:
- Set clear direction and priorities; lead with a quality mindset and compliance/integrity.
- Build inclusive, high-performing teams through coaching and development.
- Collaborate cross-functionally, influencing using data and scientific rationale; drive continuous improvement and proactive risk management.
Responsibilities:
- Lead analytical methodologies/platforms for drug substance/drug product development.
- Use project/portfolio management to deliver results on timelines.
- Review/approve data packages for scientific rigor and compliance.
- Represent the lab during internal/external audits and drive timely follow-up.
- Develop/review/maintain SOPs and controlled documents; operate within Quality Systems.
- Recruit, onboard, coach, and retain staff; build talent pipeline and succession plans.
- Maintain working knowledge of GMPs, ICH, and relevant FDA/global guidance.
Qualifications:
- BS/MS in Chemistry (or related) with 12+ years pharmaceutical drug substance and/or drug product development.
- PhD (or related) with 8+ years in the same.
Required:
- People leadership; strong scientific communication; creativity; cross-functional teamwork.
- Track record delivering results supporting development programs and regulatory filings.
Benefits/Compensation (if applicable):
- Annual bonus and long-term incentive (if applicable). Comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays/vacation, compassionate and sick days).
Application:
- Apply at https://jobs.merck.com/us/en (application deadline stated on posting). Requisition ID: R396510.