Assistant Production Lead - Early Development Center (Onsite)

Assistant Production Lead

Join us at the forefront of pharmaceutical innovation! The Formulation, Laboratory, & Experimentation Early Development Center (FLEx EDC) is a state-of-the-art Non-Sterile, predominately Oral Solid Dose (OSD), Drug Product development and GMP clinical manufacturing facility dedicated to advancing small molecule pipeline assets. We are seeking an Assistant Production Lead who is passionate about optimizing processes and driving efficiency while instilling a culture grounded in safety & compliance.

Key Responsibilities

• Collaborate with formulators, engineers, site partners, and other stakeholders to identify and deliver opportunities for process enhancements that drive operational excellence.
• Shape and refine processes for scheduling & schedule requests; incorporate the use of digital tools to streamline scheduling where possible
• Manage scheduling requests for maintenance & calibration by facilities & engineering teams to ensure minimal impact to clinical & development operations
• Ensure schedule adherence for both GMP & Non-GMP development areas
• Manage daily Tier meetings and ensure cross functional team is following up on assigned actions
• Serve as the liaison for EDC Operations at non-sterile production tiers, confirming that clinical & development batches remain on track; escalate potential issues appropriately to ensure timely resolution
• Perform walkthroughs for both safety and compliance to ensure our Company's standards are met while maintaining audit readiness
• Lead CAPA & Deviation management to ensure timely closure of any observations
• Author, review, and approve GMP procedures and documentation, with an emphasis on operation's SOPs and Work Instructions
• Facilitate the management of changes to the development & production areas; execute periodic reviews, and support Quality Management System (QMS) activities

Qualifications

The salary range for this role is $114,700.00 - $180,500.00. 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 .