USA - Pennsylvania - West Point, United States of America
Hybrid
Job Description
Global Quality Large Molecule Analytical Sciences (GQ-LMAS) – Analytical Transfer Team
Our company's Manufacturing Division, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
Global Quality Large Molecule Analytical Sciences (GQ-LMAS), in our company's Manufacturing Division, is accountable for the commercialization of large molecule, vaccines and biologics, analytical techniques from Phase III through launch and transfer to supply. This team is highly motivated, fast-paced, and focused on the rapid advancement of our Company's large molecule pipeline, plus growth of existing products. This position will specifically involve oversight of Global Filing Launch Strategy (GFLS) shipping and logistics coordination supporting product registration and Test On Importation (TOI).
Within the Global Quality Large Molecule Analytical Sciences (GQ- LMAS) organization, this Analytical Transfer Team includes activities interfacing with a global network of product manufacturing and testing sites, collaborating with product development groups within our our company Manufacturing Division and our our company's Research Laboratories division, continuous improvement of analytical methodology, assay validation, analytical technical transfer, and Biologics License Application preparation.
In this role within GQ-LMAS, opportunities include but are not limited to the following:
Manage global registration and TOI activities including shipping coordination, planning, and scheduling of shipments.
Follow up with customers after shipments to confirm shipping conditions and to resolve temperature excursions.
Manage internal and global analytical method transfer activities including shipping coordination.
Collaborate with commercial manufacturing teams to support facility start-up activities and provide analytical support both within the company's network and at contract manufacturing organizations (CMOs) or contract testing laboratories (CTLs).
Lead assignment execution against accelerated, critical-path timelines in a right-first-time manner.
Author and/or review technical documents to support analytical issues.
Support GFLS teams from a shipping and logistics perspective.
Support various vaccine and biologics registrations, launches, and troubleshooting activities external to the US, including documentation preparation and coordinate supply of critical reagent shipments.
Education Minimum Requirement:
Support various vaccine and biologics registrations, launches, and troubleshooting activities external to the US, including documentation preparation and coordinate supply of critical reagent shipments.
Bachelor of Science (Biology, Chemistry, Biochemistry, or related sciences)
Required Experience and Skills:
Detail oriented and good project management skills.
Ability to work independently.
Ability to work effectively in a collaborative team environment
Ability to learn and multi-task.
Understanding and historical application of how the sample management and logistics process support both analytical and process-based activities within commercialization
Good technical, communication (oral and written), interpersonal, and teamwork skills.
Self-motivated with a positive attitude and proven performance record.
Preferred Experience and Skills:
A minimum of 1-3 years of experience working in a GMP laboratory environment, sample / inventory management, or quality control experience.
Analytical method validation or method transfer experience.
Experience with analytical techniques (HPLC, ELISA, Capillary Electrophoresis, etc.) is a plus.
General understanding of international and domestic biological material movement regulations.
Required Skills:
Adaptability, Analytical Development, Analytical Method Development, Assay, Biologics License Application (BLA), Capillary Electrophoresis (CE), Cell-Based Assays, Communication, Customer Follow-Ups, Enzyme Linked Immunosorbent Assay (ELISA), GMP Compliance, Good Manufacturing Practices (GMP), Immunoassays, Interpersonal Relationships, Inventory Management, Laboratory Information Management System (LIMS), Laboratory Techniques, Mammalian Cell Culture, Product Registrations, Real Time Polymerase Chain Reaction (qPCR), Sample Management, Self Motivation, Standard Operating Procedure (SOP) Writing, Technical Writing, TroubleshootingPreferred 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:
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
$87,300.00 - $137,400.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An 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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
06/2/2026*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.
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