Job Description
The Vaccine Drug Substance Operations Support Lead plays a critical role in supporting the manufacturing of vaccine drug substances, ensuring compliance with regulatory requirements, and focusing on driving Execution Excellence. This position is responsible for overseeing various operational support activities, coordinating cross-functional collaboration, and providing guidance to ensure efficient and compliant operations. This is an exciting opportunity to contribute to the development and production of life-saving vaccines, making a significant impact on public health. This role will work very closely with the B21 Operations Lead.
Key Responsibilities
Provide Leadership and Direction
to the operations support team, fostering a culture of accountability, collaboration, and continuous improvement. Set clear goals and expectations, ensuring the team understands their roles in enabling timely manufacturing operations. Identify and develop key talent within the team to ensure a strong pipeline for future leadership roles.
Operations Support
Provide support to the Vaccine Drug Substance Operations Lead and Team, ensuring alignment with production goals, schedules, and quality standards. Collaborate with the Operations and cross-functional teams to develop strategies and initiatives to minimize downtime occurrences, drive Execution Excellence and improve the overall operational efficiency using 5 Foundational Competencies as the How.
Resource Allocation
Optimize the allocation of resources within the operations support team to ensure effective support for manufacturing operations. Prioritize tasks, manage workload, and assign responsibilities in a way that enables timely completion of activities and adherence to production schedules.
Team Collaboration
Foster effective collaboration and communication with team members and stakeholders across different departments (Technical Operations, Supply Chain, DMO, Quality & Engineering) to ensure seamless coordination and alignment of operational activities.
Safety & Quality Compliance
Oversee compliance with regulatory requirements, industry standards and local/global Quality standards related to vaccine drug substance manufacturing processes. Take the lead in preparing for internal and external audits by maintaining audit readiness, organising pre-audit activities, coordinating audits, and ensuring timely closure of audit findings. Collaborate with Quality Assurance/EHS to address any compliance-related issues identified during audits.
Accountable for leading and coordinating quality investigations and safety events. Analyse investigation findings, implement corrective and preventive actions, and ensure compliance with industry regulations.
Batch Record Reviews Oversight
Accountable for on-time batch record reviews.
Process Optimization / Robustness
Collaborate with cross-functional teams to implement improvements for process optimization / robustness and continuous improvement in vaccine drug substance manufacturing.
Documentation and Reporting
Ensure accurate and up-to-date documentation is maintained, including electronic batch records, standard operating procedures, and manufacturing reports. Prepare regular reports summarizing production metrics, quality indicators, and process performance.
Training and Development
Provide guidance, training, and mentorship to support the professional development of team members involved in vaccine drug substance support activities.
Cost Oversight
Assist in monitoring and controlling costs associated with operations, identifying opportunities for efficiency and cost savings.
EBR/SAP Activities
Coordinate activities related to Electronic Batch Records (EBR) and SAP, ensuring accuracy and data integrity.
Required Skills And Qualifications
* Bachelor's degree in a relevant scientific or engineering field (e.g., biochemistry, chemical engineering, pharmaceutical sciences).
* Minimum of 5 years of experience in a pharmaceutical or biotechnology manufacturing environment, with a focus on vaccine drug substance operations.
* Strong knowledge of cGMP regulations and experience working in a regulated manufacturing environment.
* Understanding of vaccine manufacturing processes and technologies.
* Proficiency in overseeing batch records reviews, technical documentation, and quality procedures.
* Familiarity with process optimization methodologies, such as Lean Six Sigma, to drive efficiency and process improvements.
* Excellent analytical and problem-solving skills, with the ability to identify and resolve operational challenges.
* Strong organizational skills and attention to detail, ensuring accuracy and completeness in documentation and reporting.
* Excellent communication and interpersonal skills, capable of working effectively in a cross-functional team environment.
* Proficiency in using manufacturing systems (e.g., electronic batch record systems, manufacturing execution systems) and Microsoft Office applications.
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
Not Applicable
Shift
Valid Driving License
Hazardous Material(s)
Required Skills
Aseptic Operations, Aseptic Operations, Biochemistry, Communication, Cost Management, Cross-Functional Teamwork, Customer Experience Management, Decision Making, GMP Compliance, Good Manufacturing Practices (GMP), Immunochemistry, Interdepartmental Coordination, Interpersonal Relationships, Lean Manufacturing, Lean Six Sigma Process Improvement, Management Process, Manufacturing Compliance, Manufacturing Quality Control, Manufacturing Support, Packaging Processes, People Leadership, Process Improvements, Production Ramp Up, Production Scheduling, Production Support {+ 5 more}
Preferred Skills
Job Posting End Date
09/15/2025
* A job posting is effective until PM 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
R364986