Scientist, Analytical R&D

Merck•Upper Gwynedd Township, PA

1d•$87,300 - $137,400•Hybrid

About The Position

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.

Requirements

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 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.

Nice To Haves

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.

Responsibilities

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.