What are the responsibilities and job description for the Director, Analytical R&D position at MERCK?
Merck Director, Analytical R&D - Rahway, New Jersey
The GMP Operations branch of Biologics Analytical Research & Development (BAR&D) seeks a driven leader to advance and commercialize complex biotherapeutics.
Check you match the skill requirements for this role, as well as associated experience, then apply with your CV below.
The Director of Compliance, reporting to the Senior Director of GMP Operations, will oversee laboratory compliance across multiple sites, managing regulatory audits, internal quality and safety audits, quality notices, CAPA management as the business area representative, as well as release and stability programs. This position is in Rahway, NJ, and will foster an inclusive culture emphasizing quality and scientific rigor for a team of 8-10 scientists.
Responsibilities include, but are not limited to :
- Lead a team of scientists to conduct validations, technical transfers, and release and stability testing.
- Manage stability activities, including protocols, reevaluation dating, sample shipments, and execution of tests within specified windows for the North American GMP Operations team.
- Ensure inspection readiness and offer prompt support during regulatory, quality, and safety inspections.
- Address audit findings and identify trends to enhance laboratory compliance.
- Conduct laboratory investigations and collaborate with stakeholders to implement corrective or preventative actions.
- Develop and track internal compliance metrics and report the observed trends to senior management.
- Provide regulatory support by preparing or reviewing high-quality CMC sections for IND / CTA / NTAs.
- Timely communication and prompt delivery of analytical results to meet project milestones and regulatory requirements.
- Set high standards, build, and develop a high performing team.
- Collaborate with the leadership team to establish departmental goals and performance objectives, support talent development initiatives, and proactively address performance-related issues.
- Recruit, hire, and develop talent to advance the organization.
Qualifications : Education :
Required :
Preferred :
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