Job Detail

JOB DESCRIPTION

Job Description

Reporting to the Vice President, Science and Technology, the Executive Director (ED), Manufacturing New Products Commercialization, will be a key member of the Science & Technology Leadership team accountable for end-to-end technical support of new and in-line products. The ED will steer the commercialization of small molecule products which are acquired or licensed externally as a key component of the company’s growth strategy. The portfolio will focus on innovative products in the women’s health and biosimilar therapeutic areas encompassing products from Phase IIB to Phase III, as well as commercially approved compounds. The portfolio's processes will be achieved in partnership with external development partners; the commercial supply will be composed of a combination of internal and external manufacturing supply.

The ED will be accountable for the technical oversight of due diligence of potential product acquisition candidates, late stage process, analytical, and packaging development, support of regulatory approval, and support of the development of robust commercial supply chain and launch. In addition, the ED will be responsible for the life cycle management of commercially approved brands that require updates due to market expansion and changes in regulatory requirements. The remit includes transitioning new products to the long-term supply chain after regulatory approval and commercial launch globally.

Core elements to enabling success in this role will include:

• Partner closely with Clinical Development, Supply Chain Management, Operations, Quality, CMC Regulatory Affairs, Business Development & Licensing (BD&L), Finance, and Marketing to advance programs through the development stages, regulatory approval, launch and ultimately transition to long term supply.


• Manage the portfolio of new products including appropriate metrics, prioritize activities across the portfolio, and steer a cross-functional governance council.


• Drive the project leadership and process development efforts for the commercialization of new products.


• Steer a cross functional group consisting of Project Team Leadership, CMC Technical Due Diligence, Pharmaceutical Commercialization Technology, Chemical Commercialization Technology, Analytical Chemistry Development, and Packaging Commercialization and Combination Product Development.


• Develop and manage a financial budget to ensure appropriate resources and expenses are allocated correctly.

Key areas of focus include:

• Technical due diligence of compound being evaluated through the corporate BD&L process.


• Oversee execution of CMC due diligence and the development of a comprehensive risk and regulatory timeline assessment that provides input into the corporate BD&L decision-making business and financial evaluation for the compound. This evaluation includes a comprehensive assessment to identify the risks for process development and ability to develop a manufacturing process that is robust, has adequate stability and capacity, meets the target product profile, and meets the product cost targets.


• Identify regulatory risks associated with the API route, the formulation design, and the analytical methods; identify the mitigation actions and their impact on the clinical programs and regulatory approval timelines.


• Develop a comprehensive product development plan outlining product requirements, associated regulatory approval timelines and how this will be managed, and key risks and tradeoff decisions.


• Provide process, analytical, and packaging development guidance, and oversight of external development partners who are engaged in the completion of process development studies and scale-up in support of registration that meet the requirements of global regulatory agencies following a Quality by Design methodology to enable the development of an end to end control strategy that ensures product quality.


• Create primary and secondary packages that are developed to meet patient needs; the product portfolio may also include Medical Device and Combination Products.


• Ensure all human factor studies, design history files and other compliance documentation needed to gain regulatory approval and maintain the product's compliance over the lifecycle are generated.


• Develop and oversee the process, packaging, distribution, and device qualifications, and analytical validation requirements that meet global regulatory agency expectations.


• Partner with CMC Regulatory and external development and manufacturing operations to create the regulatory dossiers to enable worldwide approval; ensure the approval process by providing responses to regulatory agencies.


• Partner with Supply Chain Management to ensure all clinical materials are delivered on time and the development of the commercial supply chain to ensure a robust commercial supply chain that has the required responsiveness and risk protection, and cost structure to meet the product needs over a multiple number of years post launch.

Education and Qualifications:

• B.S. / M.S. / Ph.D. in relevant Engineering or Science fields


• In-depth expertise in highly complex program and project management, systems and tools, for new product introduction in a global environment


• Strong business and financial acumen with the ability to work strategically across all levels of an organization


• Drive to create a high-performance work environment


• Strong collaborative and communication skills

#NewCo

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Employee Status:

Regular

Relocation:

Domestic/International

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R62782