Job Description

The Senior Specialist will lead and coordinate end-to-end program management activities for biologics development and commercialization. This includes overseeing the technology transfer to a Contract Manufacturing Organization (CMO). The role will act as a key interface between internal teams and external partners, ensuring seamless execution across drug substance, drug product, and packaging operations, along with support functions such as Regulatory, Quality, Supply Chain, and Finance. The individual will support the full program lifecycle within the company and report to the Program Head - AVP.
Program Management Activities will include:
Job Responsibilities:

• Lead cross-functional biologics development programs (including biosimilars) from technology transfer through commercialization, ensuring alignment with strategic goals, and timelines.
• Drive business case approvals, develop project charters, and create integrated project plans to guide execution.
• Develop and manage detailed project schedules, track execution progress, and ensure delivery within defined scope and timelines.
• Monitor project lifecycle using tools such as MS Project, Office Timeline, and Smartsheet to ensure transparency and accountability.
• Manage technology transfers to and from third-party CMOs and internal sites, ensuring knowledge capture, documentation, and risk mitigation.
• Act as the primary liaison between the company and external partners (CMOs, CROs), ensuring effective communication and collaboration.
• Coordinate with cross-functional teams including Regulatory, Quality, Supply Chain, and Finance to ensure timely and successful program deliverables.
• Follow established governance structures and escalation matrices to resolve issues and maintain program momentum.
• Negotiate with service providers and CROs for program-related activities
• Ensure data package readiness for regulatory submissions and lifecycle management filings and support regulatory agency interactions.
• Develop systems and processes to enhance operational efficiency and support PMO initiatives.
• Drive MIS (Dashboards, Data integration, Power BI, MS Project, Smartsheet) and management reporting and promote project management best practices across cross-functional teams.
• Manage Integrated Risks for project, including tracking of all mitigations.

Key Program Management Capabilities:

• Strategic Planning & Execution: Ability to define program goals, develop integrated plans, and drive execution across multiple workstreams.
• Cross-Functional Leadership: Proven experience leading diverse teams across technical, quality, regulatory, and operational functions.
• Stakeholder Engagement: Strong interpersonal skills to manage internal and external stakeholders, including CMO partners and regulatory bodies.
• Risk & Issue Management: Skilled in identifying risks early, assessing impact, and implementing mitigation strategies.
• Change Management: Ability to manage change in a dynamic environment, including scope adjustments and resource reallocation.
• Communication & Reporting: Excellent written and verbal communication skills, with the ability to present complex information clearly to senior leadership.
• Budget & Resource Management: Experience managing program resource allocation, and vendor oversight.
• Tools & Methodologies Proficiency:

• Strong command of project management tools such as MS Project, Smartsheet, and Excel-based trackers.
• Familiarity with Stage-Gate, Agile, and Waterfall methodologies.
• Skilled in using dashboards, Gantt charts, risk registers, and KPIs to monitor progress and drive decision-making.

Qualifications:

• Bachelor's or master's degree in biotechnology, Biochemistry, Chemical Engineering, or related field. Advanced degree (MBA) is a plus.
• 8-12 years of experience as a program management in the pharmaceutical/biotech industry, which operates in development and manufacturing and marketing.
• Experience managing cross-functional programs involving CMO partnerships.
• Strong understanding of GMP, regulatory requirements, and biologics manufacturing processes.

PMP certification or equivalent is desirable.
Current Employees apply
Current Contingent Workers apply
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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.
Employee Status: Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements: Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Required Skills: Adaptability, Contract Management, Creativity, GxP Validation, Information Systems, Infrastructure Project Management, Management Process, Manufacturing Operations, New Product Development, People Management, Personal Initiative, Production Facilities, Project Management, Project Management Leadership, Project Management Planning, Project Management Scheduling, Project Planning, Regulatory Compliance, Resource Management, Task Coordination, Team Management, Technical Quality Assurance
Preferred Skills:
Job Posting End Date: 07/24/2025
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