Job Abstract

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.

Position Qualifications:

Education Minimum Requirement: 

Bachelor’s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field with minimum of 6 years relevant experience, or a Master’s degree with 5 years of relevant experience, or a PhD degree with 2 years of relevant experience.

Required Experience and Skills:

• Experience with converting new drug substance process needs to an executable series of steps and procedures to enable acceptable product manufacture.

• Experienced in the administration of GMPs, Good Documentation Practices (GDPs), and S&E regulations as it pertains to pharmaceutical development.

• Experience with small molecule drug substance and/or biologics process development and scale-up, moving from laboratory to pilot scale.

• 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.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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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, generally Tuesday, Wednesday and either Monday or 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”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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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. 

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