Director, External Development and Manufacturing

Job Description

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.

Additional responsibilities are as follows:

• 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
  
• The desired individual is someone who will bring knowledge and creativity to the position as well as have the discipline to drive results.
  

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

Required Experience and Skills:

• 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
  

Preferred Experience and Skills:

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

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement•

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

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is
$169,700.00 - $267,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: -We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: -We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

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:
Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:
Biopharmaceuticals, Biopharmaceuticals, Budget Development, Business, Business Management, Cross-Functional Teamwork, Decision Making, Dosage Forms, Drug Delivery, Feasibility Studies, Financial Management, Global Procurement, GMP Compliance, Immunotherapy, Logistics Management, Management Process, Manufacturing, Mergers and Acquisitions (M&A) Support, Operational Excellence, People Leadership, Performance Monitoring, Pharmaceutical Biology, Pharmaceutical Project Management, Procurement, Project Controls {+ 4 more}

-Preferred Skills:

Job Posting End Date:
09/26/2025
*A job posting is effective until 11:59:59PM 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: R364144