Associate Director, Large Molecule Critical Reagents

Merck & Co. - West Point, PA

Full-time - Senior

Onsite - West Point, PA

Chemical Manufacturing

About the position

The LMAS Critical Reagents Associate Director will provide technical leadership and implementation support for qualification activities, key projects, and strategic initiatives to enhance the critical reagent life cycle. This role involves collaboration with various stakeholders to ensure effective strategies and optimized utilization of analytical assets, focusing on quality standards and cost control. The position requires a strong understanding of critical reagent QMS and analytical laboratory operations, along with effective communication and teamwork skills.

Responsibilities

• Provide leadership and direction for formal critical reagent projects and qualification activities.
• Design new data collection techniques and procedures for complex problem-solving initiatives.
• Monitor progress and support completion of work activities by target dates as per the LM Critical Reagents S&OP process.
• Encourage a team culture of transparency, support, and accountability.
• Ensure characterization/qualification testing plans and acceptance criteria are technically sound and aligned with acceptable business risk.
• Participate in hoshin and MPS processes to improve critical reagent activities.
• Collaboratively develop and maintain standard processes to capture and communicate key reagent risks.
• Support product decision-making forums and ensure critical reagent team contributes to product strategies.
• Participate in LMAS project portfolio process and enforce good project management practices.

Requirements

• Bachelor of Science (BS) degree in a science or applied field with seven years of experience in an analytical support function, or a Master of Science (MS) degree with five years of experience.
• Direct or indirect leadership responsibilities demonstrating effective collaboration and personnel coaching.
• Familiarity with GMP analytical laboratory operations and analytical test methods.
• Direct experience executing GMP change control and supporting GMP deviation management practices.

Nice-to-haves

• Prior experience supporting critical reagent lifecycle activities.
• Lean/six sigma or internal company MPS experience.
• Experience participating in or leading QRA or other risk assessments.
• Excellent presentation, oral and written communication skills.
• Experience supporting strategy or technical content for regulatory submissions.

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• 401k
• Paid holidays
• Flexible scheduling
• Professional development opportunities