Director, External Development and Manufacturing

Merck KGaA Darmstadt Germany • Rahway, NJ

119d • $169,700 - $267,200 • Onsite

About The Position

Our company's Pharmaceutical Sciences and Clinical Supply (PSCS) organization translates molecules to medicines, working from the discovery interface through registration stability manufacturing by designing, developing and scaling-up the formulation, device, and manufacturing process. Driving drug product design from the bench to Good Manufacturing Practice (GMP) manufacturing facilities, our scientists and engineers use cutting edge science in drug delivery and manufacturing technology to positively impact patients. The External Development and Manufacturing (ExDM) team within PSCS is focused on executing the our company Research Laboratories drug product and device sourcing strategy across all phases of small and large molecule research and development operations. The successful candidate will be responsible for managing a team of diverse professionals executing on the mission of ExDM. Their reports will manage the execution of formulation, device development and cGMP drug product manufacturing at external providers as part of a matrix team including product development teams and internal partner groups (quality, analytical, procurement, and global clinical supply). Projects may include solid oral dosage forms (tablets, capsules, modified release formulations), biologics, vaccines, or specialty dosage forms inclusive of drug-device combinations. Therefore, sufficient knowledge in the above areas is critical. Additionally, they are expected to drive one of several focus areas within the team. Including but not limited to; vendor network strategy, vendor relations, shipping and logistics, operational excellence, portfolio and pipeline management. Demonstrated expertise in one or more of these areas is essential.

Requirements

• B.S. with minimum of 18 years relevant industrial experience, M.S. with 15 years of experience or Ph.D. with 12 years of experience in a relevant field
• Demonstrated ability to communicate effectively to diverse audiences at all levels
• Effectively influence peer managers and stakeholders
• Identify and action upon forward looking business practice strategies
• Demonstrated ability to effectively lead direct reports
• Set a clear vision and navigate others through change
• Visibly display a strong sense of ownership over areas of responsibility

Nice To Haves

• Vendor management experience
• Project management experience
• Technical expertise in drug product development
• Direct drug product manufacturing experience

Responsibilities

• Oversee the outsourcing and coordination of formulation development and clinical manufacturing at Contract Research Organization (CROs)/Contract Manufacturing Organizations (CMOs) conducted by project managers
• Provide manufacturing and compliance expertise to project teams and junior ExDM members
• Identify and sponsor continuous improvement projects for the workflows within the group
• Build networks within collaboration functions to ensure operational and strategic alignment
• Provide career development mentorship to reports in addition to day-to-day coaching
• Develop broad strategies to improve current practices with internal and external stakeholders
• Maintain a strong knowledge of the external vendor landscape and a personal network within it

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays
• Vacation
• Compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree