Director of GMP Site Operations, Small Molecule AR&D

Merck • Rahway, NJ

1d • Onsite

About The Position

The Pharmaceutical Analytical Sciences team has an opening for a director based in Rahway, NJ. Join us and experience our culture first-hand - one of strong ethics & integrity, diversified experiences, exceptional science, and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
In this role, the Director will lead a team of specialists and scientists in Rahway supporting various GMP analytical activities including cleaning verification, solvent release, and in-process testing for drug substance and drug product across the entirety of our non-sterile clinical portfolio during 1st and 2nd shift operations at the Rahway site. This particular role is fully onsite during 1st shift operations.
The Director is responsible for ensuring cGMP compliance and operational excellence in the laboratories, and for always maintaining a state of inspection readiness. The Director should be engaged with regulatory and industry trends and have thorough working knowledge of GMPs, ICH, and relevant FDA guidelines.
In addition, the Director will effectively team with the Pharmaceutical Analytical leadership, and extended leadership teams to identify and advance key departmental strategic and cultural initiatives. The Director will identify, recruit, onboard, and develop employees to their full potential. The role will also be responsible for proactive resourcing planning, risk assessment strategies, and budget management as necessary.

Requirements

• Excellent scientific communication skills, demonstrated creativity, effective interpersonal and collaborative skills
• Demonstrated ability to lead teams to deliver high-quality results against firm deadlines
• Proven talent development skillsets
• Ability to partner in a team environment with cross-functional interactions to drive results
• BS or MS in chemistry or related science with at least 10 years of industry experience with pharmaceutical drug substance and/or product development.
• Ph.D. in chemistry or related science with at least 7 years of industry experience with pharmaceutical drug substance and/or product development.
• Adaptability
• Analytical Method Development
• Biologics License Application (BLA)
• Chromatographic Techniques
• Compliance Oversight
• Decision Making
• Dosage Forms
• Drug Screening
• GMP Compliance
• Inspection Readiness
• Internal Resourcing
• Operational Excellence
• People Leadership
• Pharmaceutical Sciences
• Process Analytical Technology (PAT)
• Product Development
• Professional Networking
• Regulatory Compliance
• Regulatory Submissions
• Results-Oriented
• Risk Assessments
• Risk Evaluation And Mitigation Strategy (REMS)
• Science Communication
• Talent Development

Nice To Haves

• Prior experience managing a GMP analytical lab that supports cleaning verification, IPC, and solvent release.
• Prior experience with lab investigations/deviations and compliance audits is a plus.

Responsibilities

• Leading a team of specialists and scientists supporting cleaning verification, solvent release, and in-process testing for drug substance and drug product during 1st and 2nd shift operations
• Ensuring on-time, right first-time analytical testing of to enable clinical manufacture of drug substance and drug product
• Provide technical and compliance oversight on lab investigations and deviations
• Review and approval of GMP data, release specifications, analytical reports, Certificates of Analysis, and SOPs.
• Serve as the site-based analytical support lead during internal and external compliance audits
• Ensure operational excellence and drive process improvements
• Staff development and talent recruiting
• Work with the leadership team to help drive departmental strategic and cultural initiatives

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees