Director, Small Molecule AR&D, Raw Materials & Medical Device
Director, Small Molecule AR&D, Raw Materials & Medical Device
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$ 169700 - 267200
1 Vacancy
Job Description
Job Description
Raw Materials & Medical Device Director Small Molecule Analytical Research & Development
The Small Molecule Analytical Research and Development (SMAR&D) team has an opening for a Director based in Rahway NJ. Join us and experience our culture first-hand - one of strong ethics & integrity diversified experiences exceptional science and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global team you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
In this role the Director of the Raw Materials and Medical Devices/Combination Products (MDCP) will lead a team of specialists and scientists in Rahway supporting raw material package component and medical device component/combination product release testing across the entirety of our non-sterile and sterile clinical portfolio. The Director is responsible for ensuring cGMP compliance and operational excellence in the laboratories and for always maintaining a state of inspection readiness. The Director should be well engaged with regulatory and industry trends and have thorough working knowledge of GMPs ICH and relevant FDA guidelines.
In addition the Director will effectively team with the SMAR&D leadership and extended leadership teams to identify and advance key departmental strategic and cultural initiatives. The Director will identify recruit onboard and develop employees to their full potential. The role will also be responsible for proactive resourcing planning risk assessment strategies and budget management as necessary.
Primary Responsibilities:
Leading a team of specialists and scientist supporting raw material release and medical device & combination product testing
Ensuring on-time release testing of raw materials to enable clinical manufacture right first time
Contract laboratory oversight including supporting any lab investigations and deviations
Review and approval of GMP data release specifications analytical reports Certificates of Analysis and SOPs.
Serve as the raw material & MDCP SME during internal and external compliance audits
Ensuring operational excellence and drive process improvements
Staff development and talent recruiting
Work with the leadership team to help drive departmental strategic and cultural initiatives
Education Minimum Requirements:
Ph.D. in chemistry or related science with 8 years of industrial experience with pharmaceutical drug substance and/or product development.
MS in chemistry or related science with 10 years of industrial experience with pharmaceutical drug substance and/or product development or BS or related science with 12 years of industrial experience with pharmaceutical drug substance and/or product development.
Required Experience and Skills
Excellent scientific communication skills demonstrated creativity effective interpersonal and collaborative skills
Demonstrated ability to lead teams to deliver high-quality results against firm deadlines
Proven talent development skillsets
Ability to partner in a team environment with cross-functional interactions to drive results
Preferred Experience and Skills
Though not required the ideal applicant would have prior experience managing a GMP lab that supports raw material excipient and/or package component release testing. Prior experience with medical device components and combination products is a plus.
#AR&D
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:
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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:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Adaptability Adaptability Analytical Method Development Applied Engineering Biologics License Application (BLA) Business Chromatographic Techniques Combination Products Cross-Functional Teamwork Decision Making Dosage Forms GMP Compliance Inspection Readiness Management Process Medical Device Management Medical Devices Operational Excellence People Leadership Process Analytical Technology (PAT) Product Development Professional Networking Regulatory Compliance Regulatory Submissions Release Testing Results-Oriented 5 morePreferred Skills:
Job Posting End Date:
07/17/2025*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
