Associate Director, Small Scale Organics (SSO) Facility Lead

Job Description

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.
  

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Position Qualifications:

Education Minimum Requirement:-

• Bachelor's degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field with minimum of 8 years relevant experience, or a Master's degree with minimum 7 years of relevant experience, or a PhD degree with minimum 3 years of relevant experience.
  

Required Experience and Skills:

• Experience with small molecule drug substance and/or biologics process development and scale-up, moving from laboratory to pilot scale.
  
• Experienced in the administration of GMPs, Good Documentation Practices (GDPs), and S&E regulations as it pertains to pharmaceutical development.
  
• Experience providing technical mentorship.
  
• Effective interpersonal and communication skills, both written and verbal.
  
• Excellent time management and organizational skills.
  
• Desire and willingness to learn, contribute, and lead.
  
• Track-record of independent problem-solving.
  

Preferred Experience and Skills:

• Operations experience in a GMP clinical supply facility (intermediate scale or pilot plant) or manufacturing environment.
  
• Experience supporting compliance investigations and change management.
  
• Experience working with Quality systems.
  
• Experience working in an environment with an Automation System (DeltaV, PLC, etc.).
  
• Experience with managing direct reports or matrix teams.
  

#PR&D #PRD PR&D PRD

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 a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

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 .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: -We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: -We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully-
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.-

Employee Status:
Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:
Adaptability, Adaptability, Applied Engineering, Biopharmaceutics, Chemical Engineering, Customer-Focused, Data-Driven Decision Making, Deviation Investigations, Driving Continuous Improvement, Drug Product Development, Estimation and Planning, Fast-Paced Environments, GMP Compliance, Immunochemistry, Industrial Hygiene, Innovation, Inventory Management, Management Process, Manufacturing Quality Control, People Management, Pharmaceutical Biology, Pharmaceutical Development, Pharmaceutical Process Development, Process Control Automation, Process Optimization {+ 5 more}

-Preferred Skills:

Job Posting End Date:
10/17/2025
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R367304