Job Description

JOB PURPOSE

The PTO Associate Director Engineering/ Chemistry (M2) ensures oversight, coaching of the technical team on their technical support activities related to the commercialization and the manufacture of all drug products on site. These activities include (but are not limited to) product and cleaning validations, technology transfer, audit/compliance support, process monitoring, product portfolio and new product introduction. The PTO Associate Director Engineering / Chemistry demonstrates advanced knowledge of the end-end supply chain and must work effectively within cross-functional teams in establishing priorities for the IPT and department. In addition, he/she provides technical guidance/direction for the PTO engineers/ chemists with the technical knowledge/ compliance knowledge/ essential skills needed for their technical supply support activities.

The PTO Associate Director is expected to build and develop his/her teams. He/ She will have people management responsibilities and is accountable for establishing the priorities and providing oversight of career development plans for their direct reports. In addition, he/she leads and provides subject matter expert (SME) technical guidance to the site and regionally in process improvement activities, investigations and contributes to global technical networks to share site and regional experiences. The PTO Associate Director Engineering/ Chemistry also leads continuous process improvement or strategic initiatives activities to enhance site performance metrics and provides expert knowledge to the site and across the our global company technical network (while leveraging on other site experiences/ knowledge) and continuously expands on personal expertise.

WHAT YOU WILL DO

MAIN RESPONSBILITIES (Priorities to be aligned with direct supervisor)

Coaches and mentors, the PTO Engineers / Chemists on their technical support activities related to commercialization and manufacture of drug products on site. Key activities include but are not limited to:

• New product introductions, technology transfer activities

• Deviations and customer complaints investigations

• Proactive process analysis and monitoring

• Process and cleaning related activities (such as equipment qualification, validation, verifications, monitoring, CPV, APR activities)

• QMS topics especially for PTO owned topics

• Audit/ Compliance support

• Product portfolio

• Real time problem solving (RIPS) for shop floor investigations

• Statistical and problem-solving tools

Is conversant and able to coach in all technical support areas. Accountable for his/her teams in the respective IPT areas by making results/issues visible, effectively managing the execution of the activities and addressing issues systematically.

• Provides technical support for new product transfers to other sites, investigations to deviations and process improvement activities to improve robustness as well as technical training to build capabilities at site or regionally. Expected to leverage on industry practices to enhance or transform current practices and processes, lead the implementation of new technology or practices to the site and regionally. Expected to be the SME on specific technical knowledge related to process engineering, scale up, designing experiments, etc.

• Provides oversight and is expected to have at least advanced knowledge on technical supply support. Expected to possess advanced knowledge and is likely to be a SME in specific technical/process engineering knowledge related to relevant drug substance/drug product non-sterile or sterile manufacturing technologies. Supervises complex equipment/process/automation changes as required for process improvements, including changes to process/cleaning batch sheets.

• Expected to stay abreast of recent developments in major regulatory guidance issued by the FDA, EMA etc., and proactively assess impact and changes required for the current operations.

• Supports routine supply manufacture by providing ongoing technical support to the IPT during manufacturing and cleaning and regulatory audits. Expected to positively influence site partners (IPT, Quality) on process improvements, remediation plans and the introduction of proactive monitoring for the various manufacturing processes. Expected to lead/support the identification and prioritization of opportunities for continuous process improvements based on feedback from proactive monitoring in the plant, e.g. through Proactive Process Analysis (PPA).

• In addition, provides ongoing technical support to the IPT, participates in Tier processes and recommends projects/opportunities for improvement and implements opportunities for improvement utilizing MPS (our Production Systems) tools. Ensures optimum production runs, identifies constraints and non-conformances and troubleshoots to resolve complex issues in production systems. In addition, conceptualizes process designs to troubleshoot and resolve complex operational or manufacturing issues and recommend enhancements to improve production runs and enable continuous improvement of the product cost structure.

• Leads significant/ complex investigations.

• Serves as technical approver for deviation investigations, cleaning, process validations, risk assessments, change controls, CPV and other technical documents as applicable.

• Leads and drives strategy and initiatives aligned to site and functional HOSHIN. Leads workstreams or initiatives in driving benefits to transform the business, products, processes or unit operations with respect to technical excellence, robustness, risk mitigation and compliance.

• Collaborates with site functional groups in delivery of site targets and shows commitment to collaboration and sharing of best practices across the our global company S& T network.

• Demonstrates and promotes Environmental, Health & Safety (EHS) leadership behaviors, ensuring that all activities are carried out in accordance with EHS requirements. Actively participates in GEMBA safety walks. Leads/ participates in process hazards analyses (PHA) and applicable Process Safety Management (PSM) activities related to new/commercial products.

• Where applicable, writes and reviews SOPs, gap analyses and Job Aids for PTO QMS topics in compliance with divisional and corporate policies and Qllidelines.

• Demonstrates leadership behaviors in alignment with our leadership standards (Individual Contributor/Manager), specifically on Fostering Collaboration, Building Talent and Driving Results. Practices Inclusion, Safe by Choice principles and possesses a strong our Production Systems (MPS) mindset. Leads personal career development with manager assistance through annual Performance Management Process (PMP), Employee Development Plan (EDP) and career mappmg.

• Has primary oversight for the development of engineers/chemists through administration of the individuals' priorities, EDP and career mapping.

ACCOUNTABILITIES

• Conducts all activities in compliance with site and divisional policies, guidelines and procedures and within the defined safety requirements.

• Successfully completes end to end technology transfers into or out of the site through provision of oversight to technology transfer team(s).

• Successfully executes changes to validated systems: process/ equipment/ automation and cleaning either directly or through supervision of direct reports and/or junior staff.

• Delivers on all assigned department and cross functional initiatives within the required time frame

• Resolves complex deviations, investigations and customer complaints with proper root cause analysis and CAPAs.

• Leads workstreams or initiatives in driving benefits to transform the business, products, processes or unit operations with respect to technical excellence, robustness, risk mitigation and compliance.

• Builds knowledge and experience to expand responsibilities for the next role in PTO.

• Administers robust and sustainable people development plan for direct reports.

WHAT YOU MUST HAVE

Qualification:

• Bachelors, master's or Ph.D. degree in a technical field, including Chemical or Mechanical Engineering, Chemistry or Pharmaceutical Sciences.

Experience:

• Minimum 8 years technical experience in related pharmaceutical manufacturing industry

• Minimum 2 years in supervisory position of professional staff or demonstrated capability to successfully lead large teams in complex projects.

• Expert knowledge of core technology/unit operations relevant to active pharmaceutical ingredient, Biotech and/or Non-Sterile manufacturing.

Who we are

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

Required Skills:

Computerized Maintenance Management Systems (CMMS), Cross-Cultural Awareness, GMP Environments, Maintenance Supervision, Manufacturing Quality Control, People Leadership, Pharmaceutical Development, Process Engineering, Process Improvements, Regulatory Compliance, Regulatory Inspections, Single-Use Systems (SUS), Sterile Manufacturing, Strategic Thinking, Team Leadership

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/10/2026

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