Director, Pharmaceutical Commercialization Technology

Our company is a global health care leader with a diversified portfolio of small molecules, biologics, and vaccines across human and animal health. We are building a new kind of healthcare company, one that is ready to help create a healthier future for all of us. Join our team and contribute to our mission of delivering innovative health solutions that advance the prevention and treatment of diseases in people and animals.

The Pharmaceutical Commercialization Technology (PCT) organization, within our Manufacturing Division, develops robust processes and technologies for small-molecule, solid-dosage drugs. From early formulation partnerships through to commercial launch and stable global supply, we bridge the gap between discovery and patients worldwide. Our operations are anchored by development centers in Rahway, NJ and West Point, PA, alongside a global manufacturing network spanning Ireland, Singapore, and external contract organizations.

As the Director of Pharmaceutical Commercialization Technology, you will lead a high-performing department of 10 to 20 engineers and scientists-ranging from entry-level researchers to senior scientific leaders and people managers.

In this role, you will shape and execute program strategies for our development pipeline while fostering a culture anchored in Safety First, Quality Always, and Inclusion for All. You will champion talent development, drive operational excellence, and build highly collaborative partnerships across our global technical, quality, and manufacturing networks to bring life-saving medicines to market.

Responsibilities

• Drive development of product portfolio including overall plan for control strategy development, experimental designs across scales, execution of experimental plans, and data analysis with the goal of creating robust control strategies that will lead to reliable supply.
• Drive results and executional excellence within the department’s portfolio, impacting multiple layers of the organization and other lines within PCT.
• Drive operational excellence by clarifying and translating priorities into actionable steps and holding teams accountable to deliver against priorities.
• Recognize gaps in systems and drive improvement in process and department function, sponsoring and driving a culture of continuous improvement throughout the organization.
• Develop critical partner relationships and create sponsorship frameworks with peers to ensure the success of highly cross-functional teams.
• Actively sponsor the creation of high-performing teams with peers and ensure necessary technical reviews are occurring proactively with the right cross-section of peer partner groups.
• Utilize a sophisticated employee development toolkit across many levels within the organization, including people managers, senior scientific staff, and new hires.
• Help teams drive programmatic strategy including regulatory, siting, and tech transfer, and assist in creating financial forecasts.
• Lead change throughout the organization with a well-developed change leadership toolkit.
• Oversee the department’s core functions including PCT Source (clinical supply stewardship), the APEX (Applied Pharmaceutical Engineering & eXperimentation) supply-support facility, safety teams, digital strategy, compliance, modeling, risk assessment platforms, diversity and inclusion, due diligence, and capital projects.

Required

• Bachelor of Science (B.S.) degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of twelve (12) years of required experience; OR Master of Science (M.S.) with a minimum of ten (10) years; OR Ph.D. degree with a minimum of eight (8) years.
• Possesses deep technical and subject matter expertise with the function.
• Knowledge of oral drug product formulation and process development, proven track record in small molecule commercial process development, scale-up, and technology transfer to supply.
• Applies a deep understanding of new product development and commercialization.
• Experienced in the end-to-end development of drug products from commercialization through to supply.
• Experience with authoring regulatory submissions and responding to regulatory questions.
• Excellent interpersonal, communication, and collaboration skills.
• Effective delegation skills and demonstrated ability to drive improvement priorities in addition to driving the portfolio.
• Demonstrated ability in leading and sponsoring cross-functional teams.
• Strength in delivering results on firm deadlines.
• Experience with leading organizational change.

Preferred

• Experience in supporting supply investigations.
• Proficient in situational effectiveness and can structure communications to technical teams and executive level.

Location: Rahway, NJ preferred. Candidate will have reports based in Rahway and West Point, PA, so travel to West Point will be required., Adaptability, Change Agility, Consulting, Good Manufacturing Practices (GMP), Key Client Relationships, Manufacturing Scale-Up, People Leadership, Pharmaceutical Process Development, Process Characterization, Regulatory Experience, Research and Development Operations (Inactive), Results-Oriented, Teamwork, Technical Transfer, Writing Technical Documents

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

The salary range for this role is

$173,200.00 - $272,600.00

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.