Associate Director, Process Engineer - Oral Solid Dosage, Clinical Manufacturing (Onsite)

$135,500 - $213,400/Yr

Merck & Co. - Rahway, NJ

Full-time - Senior

Onsite - Rahway, NJ

Chemical Manufacturing

About the position

The Associate Director, Process Engineer for Oral Solid Dosage at the FLEx Center in Rahway, New Jersey, is responsible for leading clinical supply manufacturing and ensuring the scientific rigor of processes. This role focuses on non-sterile formulations, particularly oral solid dosage forms, and aims to enhance the flexibility and speed of the company's pipeline. The position involves managing a team of process engineers, overseeing GxP documentation, and fostering collaboration across various departments to achieve specific goals.

Responsibilities

• Lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical supplies.
• Manage a team of 2-5 process engineers, providing coaching and development guidance.
• Review and approve GxP documentation including batch records, specifications, equipment qualifications, change records, and deviations.
• Build partnerships and leverage relationships within and across work groups of formulators, engineers, safety, and quality representatives.
• Foster a culture of collaboration, learning, and innovation.
• Support in setting specific and measurable short- and long-term goals.

Requirements

• Associate's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related field with a minimum of 12 years relevant experience.
• Bachelor's in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 10 years relevant experience.
• Master's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 8 years relevant experience.
• PhD in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 5 years relevant experience.
• Experience leading GxP manufacturing in a pilot plant environment.
• Experience reviewing and approving GxP documentation, quality investigations, and change management.
• Extensive knowledge and experience of drug product processing.
• Experience managing and developing a team, including identifying and assessing goals and creating a learning environment.
• Familiarity with US and EU GMP and Safety compliance regulations.
• Effective interpersonal and communication skills, both verbal and written.

Nice-to-haves

• Knowledge of Investigational drug regulatory requirements.
• Audit experience: safety, environmental, compliance/quality.
• Understanding of Clinical Supply Chain Operations.
• Experience with Commissioning, Qualification, and Validation.
• Experience with spray dried intermediates and/or hot melt extrusion.

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays
• Vacation
• Sick days