Job Description
The selected candidate will work in the Pharmaceutical Analysis & 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 large molecule development programs at various stages of development. The scope of the role will include realization of the analytical R&D externalization strategy by building analytical capabilities and driving a culture of scientific and operational excellence 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 drug substance and drug product deliverables 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 Bioprocess, 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 a scientist or engineer seeking to gain externalization experience, lead the capability build at an external partner, provide oversight to multiple programs, and broaden their experience in large 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, WG’s (Working Groups), Bioprocess Research & Development External Capabilities, and TPQM (Third Party Quality Management) to manage externalized projects.
- Lead analytical development for all large molecule drug substance and drug product deliverables sited at selected external partners including testing, analytical method qualifications/transfers, technical oversight, and resolution of analytical issues.
- Lead and apply project management skills to analytical method validation and transfer activities for pipeline commercialization projects, ensuring testing site readiness.
- 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 AR&D 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 with a minimum of 3 years of experience
- Bachelor’s degree with a minimum of 5 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 working independently in a fast-paced and dynamic environment and navigating competing priorities.
- Strong knowledge of biologics CMC landscape including knowledge of GMP, ICH and relevant HA guidelines.
- Strong understanding of regulatory validation guidelines and prior experience of successfully implementing validation best practices.
- Experience with a wide variety of analytical methods, including biochemical and biophysical 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 20% of time.
Required Skills
Adaptability, Analytical Method Development, Analytical Validation, Assay Development, Bioanalytical Analysis, Biochemical Assays, Bioprocess Engineering, Bioproducts, Cell-Based Assays, Chromatographic Techniques, Critical Thinking, Digital Technology, Endevor, Financial Forecasting, GMP Compliance, GMP Environments, Innovative Thinking, Operating Models, Pharmaceutical Sciences, Project Management, Project Resource Management, Strategic Thinking, Technical Writing, Ultra Performance Liquid Chromatography (UPLC), Vaccine Development
Preferred Skills
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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.
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.
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
$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
Hybrid
Shift
1st - Day
Valid Driving License
No
Hazardous Material(s)
n/a
Job Posting End Date
05/8/2026
- 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:R396090
