Director, External Development and Manufacturing
Director, External Development and Manufacturing
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 169700 - 267200
1 Vacancy
Job Description
Job Description
Our companys 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 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:
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 anothers 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 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
$169700.00 - $267200.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees 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 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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
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 morePreferred Skills:
Job Posting End Date:
09/26/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Director
Employment Type
Full-Time
