Job Description
At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join us in our mission to use the power of leading-edge science to save and improve lives around the world.
The Analytical Project Lead role includes driving analytical strategy, managing analytical procedure lifecycle activities, maintaining a robust assay monitoring effort, participating in product strategy discussions, global method ownership, and many other cross functional activities. This position will require effective collaboration with external contract providers as well as colleagues in our research laboratories, supply chain, site, and global Quality, as well as CMC-Regulatory.
Responsibilities
- Collaborate across the internal network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) in large molecule analytics
- Coordinate with analytical and process development groups to prepare for and coordinate analytical troubleshooting, validation and technology transfers between our company, external partners and CMO/CROs
- Guide cross-functional teams and ensure alignment with analytical strategies and Quality Systems in support of analytical procedure lifecycle management
- Steer teams of subject matter experts to develop and optimize existing biochemical, immuno-chemical and chromatography-based analytical methods to enable modernization of our testing strategies
- Accountability for analytical method transfers and in-line assay method validations, including review of protocols and reports
- Routine assay monitoring and trending to ensure a robust analytical testing network
- Ownership of product-specific global analytical methods including routine evaluation of methods for analytical lifecycle changes
- Escalation of key project challenges to management in a timely and concise manner
- Partnership with critical reagent and reference standard groups to ensure unconstrained supply of reagents required for routine analytical testing
- Perform technical review of analytical change requests, atypical analytical results, Out-Of-Specification results, and analytical methods
- Coordinate analytical issue resolution via subject matter experts within the global large molecule network
Qualifications
Required
- Bachelor’s Degree with a concentration in sciences with eight (8) years of experience working in the field of analytical testing, development, transfer, and/or validation; OR Master’s Degree with six (6) years; OR PhD with three (3) years
- Effective communication and teamwork
- Experience with large molecule GMP testing including drug substance and drug product stability and release testing
- Experience with analytical comparability
- Experience leading a cross-functional team
- Strong technical expertise in general large molecule analytical laboratory operations, equipment and techniques
Preferred
- Continuous improvement or Project Management training
- Experience with global product supply
- Writing or reviewing of regulatory filings (IND, MAA, BLA, PAS, CBE) and inspections with multiple agencies (FDA, EMA, JNDA)
- Experience with large molecule analytical transfers
- Experience with change controls
- Experience with assay monitoring and trending
Required Skills:
Adaptability, Adaptability, Analytical Method Development, Analytical Testing, Assay, Assay Development, Biochemical Assays, Biological Assay Development, Cell-Based Assays, Chromatographic Techniques, Collaborative Communications, Cross-Functional Teamwork, Effective Written Communication, External Collaboration, Global Product Management, Global Supply Chain, GMP Compliance, GMP Operations, GMP Training, High Resolution Mass Spectrometry (HRMS), In Vitro Assays, Liquid Chromatography-Mass Spectrometry (LC-MS), Management Trainings, Mass Spectrometry Analysis, Optimism {+ 7 more}
Preferred Skills:
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
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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
The salary range for this role is
$142,400.00 - $224,100.00
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:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
07/11/2026*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: R404076
