Assistant Production Lead - Early Development Center (Onsite)

Job Description

Location: Rahway, New Jersey
Department: Pharmaceutical Operations and Clinical Supply
 

Position Overview

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

• Bachelor's Degree in Engineering or Science plus a minimum of 5 years of related Drug Product/Oral Solid Dose (OSD) manufacturing & development experience.

• Familiarity with Quality, Regulatory, cGMP, Safety & Environmental Policies and Procedures

• Strong technical writing skills to prepare Standard Operating Procedures (SOP) and cGXP documents

• Exceptional organizational and analytical abilities with a keen eye for detail

• Strong computer skills with preference for SAP experience

• Strong communication and interpersonal skills to foster collaboration across diverse teams

• A proactive mindset with a knack for identifying inefficiencies and proposing innovative solutions; Lean Six Sigma certification preferred

PSCS

#eligibleforERP

Required Skills:

Analytical Method Development, Analytical Method Development, Analytical Thinking, Calibration Management Software, Calibration of Equipment, Collaborative Communications, Communication, Cross-Functional Teamwork, Deviation Management, Drug Development, Facility Design, GMP Compliance, Interpersonal Relationships, Lean Six Sigma (LSS), Management Process, Manufacturing, Manufacturing Process Validation, Operational Excellence, Personal Initiative, Process Optimization, Product Testing, Project Team Leadership, Quality Management, Quality Management System Auditing, Self-Management {+ 3 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As<