Scientist, Analytical R&D

Job Description

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 external contractors, suppliers, and partners, comprise a global manufacturing network that delivers a compliant, reliable supply to customers and patients on time, every time, across the globe.

GQ‑LMAS is accountable for the commercialization of large molecule vaccines and biologics, covering analytical techniques from Phase III through launch and transfer to supply. The team is highly motivated, fast‑paced, and focused on the rapid advancement of our large molecule pipeline and the growth of existing products. This position includes oversight of Global Filing Launch Strategy (GFLS) shipping and logistics coordination for product registration and Test on Importation (TOI), as well as ongoing interface with a global network of product manufacturing and testing sites, collaboration with product development groups, continuous improvement of analytical methodology, assay validation, analytical technical transfer, and Biologics License Application preparation.

• 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 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 outside the US, including documentation preparation and coordination of critical reagent shipments.

• Bachelor of Science (Biology, Chemistry, Biochemistry, or related sciences)

• Detail oriented and good project management skills.
• Ability to work independently.
• Ability to work effectively in a collaborative team environment.
• Ability to learn and multitask.
• Understanding and historical application of how the sample management and logistics process supports 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.

• 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.

• 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
• Troubleshooting

We are 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,…