Associate Director, Small Scale Organics (SSO) Facility Lead

SSO Facility Lead

The Small Scale Organics (SSO) Pilot Plant is a Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization which enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology / processes, training opportunities for improved manufacturing process development, and seamless technology transfer to commercial sites. The SSO Pilot Plant is seeking a highly motivated and technically focused individual to work in a fast-paced job that provides a high degree of technical, project, and people management responsibility.

This SSO Facility Lead role within the SSO Pilot Plant leverages significant depth and breadth of scientific, technical, and operational experience to lead and support facility operations, process development activities, compliance investigations / change management, authoring of GMP documentation, and lead other staff in the pilot plant as needed. The position is also responsible for implementing actions to meet Safety and Environment (S&E) and GMP requirements as well as ensuring facility readiness for batch processing. In addition, this position is expected to work cooperatively with other members of the SSO leadership team and SSO partners to drive overall success of the pilot plant. The Facility Lead position reports to the Director of Operations / Head of SSO Pilot Plant and the successful candidate will be an integral member of the SSO process and production team at the Rahway NJ facility.

Responsibilities of the role include but are not limited to :

• Lead, prepare for and / or support batch processing readiness and execution activities.
• Prepare, review, and / or approve GMP documentation as appropriate.
• Author / Approve Standard Operating Guidelines and Procedures.
• Support equipment and facility maintenance activities.
• Support equipment setup and cleaning and raw material inventory management activities.
• Support API release, and initiate, track and / or execute shipment of GMP materials.
• Foster a culture of collaboration, learning, and innovation.
• Serve as a technical mentor and help train rotational and new employees.
• Supervise staff performing GMP activities and deliver training as needed.
• Support deviation investigations, corrective / preventative action closures, and building initiatives as appropriate.
• Collaborate closely with development engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the processes, and enable flexibility and speed of the Company's pipeline.
• Ensure processes are run within the capability constraints of the facility.
• Provide regular feedback to peers to promote a continuous improvement mindset and collaborate with all building staff to share and align on best practices.
• Author lessons learnt through after action review summaries or other reports to capture knowledge gained.
• Drive new technology development projects through participation in equipment design and testing as well as preparation, review, and completion of GMP documentation.
• Support compliance with Industrial Hygiene (IH) program by leading or participating in IH sampling activities for new or existing equipment.
• Support data rich experimentation at pilot scale via process analytical technologies (PAT) implementation in the SSO.

Position Qualifications :

Required Experience and Skills :

Preferred Experience and Skills :

The salary range for this role is $139,600.00 - $219,700.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https : / / jobs.merck.com / us / en / compensation-and-benefits .