Job Description
Senior Scientist (R3), Analytical External Capabilities, Validation & Compliance (ECVC), Small Molecule
The selected candidate will work in the Pharmaceutical Analysis and Digital Technologies (PADT) department within the Development Sciences and Clinical Supplies (DSCS) organization and serve as a primary point of contact for externalized analytical deliverables supporting small molecule drug substance and drug product programs at various stages of development. The scope of the role will include realization of the AR&D externalization strategy by leading the build of analytical capabilities and driving a culture of scientific and operational excellence within our team and at our external partners including oversight of a rapidly growing team of external analysts. The candidate will partner with cross functional Development and Commercialization Teams (DCT’s) and external partners to establish timelines for small molecule drug substance and drug product development and clinical deliveries and will provide oversight of method development, method transfer, as well as release and stability testing for multiple programs. The candidate will also partner with Process, Formulation, Engineering, Quality, and interdivisional stakeholders to grow our relationships with select vendors by leveraging our company’s ways of working and transform them into strategic partners. This role represents an excellent opportunity for an analytical scientist seeking to gain externalization experience, lead the capability build at an external partner, provide oversight to multiple programs at any given time, and broaden their experience in small molecule development.
Primary Responsibilities
- Execution of AR&D’s externalization strategy and optimization of the operating model to deliver results aligned with enterprise goals.
- Partner with cross functional DCT’s, Working Groups, other external partner management and quality groups to manage externalized projects.
- Lead analytical development for all small molecule deliverables sited at selected external partners including testing, analytical method qualifications/transfers, technical oversight, and resolution of analytical issues.
- Lead analytical capability build at selected external partners by identifying focus areas that support our company's current and future pipeline and working closely with internal SMEs to upskill external partners.
- Partner with internal PADT stakeholders to author technical protocols, reports, and review technical documents.
- Ensure high quality documentation from external partners consistent with a compliance mindset.
Education Minimum Requirements
Applicants must hold one of:
- Ph.D. in Chemistry, Pharmaceutical Science, or related discipline.
- Master’s degree in Chemistry, Pharmaceutical Sciences, or related discipline with a minimum of 4 years of experience
- Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related discipline with a minimum of 7 years of experience
Preferred Experience & Skills
- Outstanding communication, critical thinking, and leadership skills.
- Effective interpersonal skills and demonstrated ability to overcome challenges and align stakeholders toward a common goal.
- Project management experience including resource management, budget forecasting, and risk assessment/mitigation planning.
- Experience with working independently in a fast-paced and dynamic environment and navigating competing priorities.
- Strong knowledge of small molecule CMC landscape including knowledge of GMP, ICH and relevant HA guidelines.
- Experience with a wide variety of analytical methods, including chemical and physical characterization.
- Demonstrated track record of working across networks, both internally and externally, to deliver exceptional results aligned with program timelines.
- Travel (Domestic and/or International) up to 10% of time.
Tag: #AR&D
#eligibleforERP
Required Skills
Adaptability, Adaptability, Analytical Method Development, Biopharmaceuticals, Chemical Biology, Chemical Physics, Chemical Proteomics, Chemical Synthesis, Chemometrics, Chromatography, Data-Driven Decision Making, Financial Forecasting, Flow Cytometry, GMP Compliance, Mass Spectrometry Based Proteomics, Medicinal Chemistry, Motivation Management, Operating Models, Operational Excellence, Organizational Optimzation, Pharmaceutical Sciences, Process Analytical Technology (PAT), Project Management, Project Resource Management, Protein Chromatography {+ 1 more}
Preferred Skills
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Current Contingent Workers apply HERE
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Requirements
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:
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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.
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The salary range for this role is
$117,000.00 - $184,200.00
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 https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (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:
Domestic
VISA Sponsorship
Yes
Travel Requirements
10%
Flexible Work Arrangements
Not Applicable
Shift
1st - Day
Valid Driving License
No
Hazardous Material(s)
n/a
Job Posting End Date
05/27/2026
- 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:R396425
