Associate Principal Scientist, Analytical R&D

Merck•Durham, NC

2d•$142,400 - $224,100•Onsite

About The Position

The Associate Principal Scientist position will support our Live Virus Vaccines (LVV) franchise. This broad role includes 1) working with Analytical Product Leaders (APLs) to develop and implement analytical strategies, with special focus on transition from clinical to commercial stages; 2) driving method alignment and supporting consistent executional excellence across multiple testing laboratories; 3) developing and maintaining a robust assay monitoring effort and supporting method procedure life cycle management, including automation and/or modernization as applicable. This position is technical in nature and demonstrated expertise in vaccine analytics is required. The role also requires 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. This role will be based in West Point, PA and it’s a site-based position.

Requirements

Bachelor’s Degree (BA/BS) with a concentration in sciences with six (6) years of experience working in the field of analytical testing, development, transfer, and/or validation; OR Master’s Degree (MA/MS) with a concentration in sciences with four (4) years of experience working in the field of analytical testing, development, transfer, and/or validation; OR PhD with a concentration in sciences with two (2) years of experience working in the field of analytical testing, development, transfer, and/or validation.
Demonstrated experience with analytics for commercial vaccine and/or microbiological products.
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.
Adaptability
Analytical Method Development
Assay Development
Biological Assay Development
Cell-Based Assays
Chromatographic Techniques
Cross-Functional Teamwork
External Collaboration
High Resolution Mass Spectrometry (HRMS)
Liquid Chromatography-Mass Spectrometry (LC-MS)
Mass Spectrometry Analysis
Optimism
Process Analytical Technology (PAT)
Protein Analysis
Teamwork

Nice To Haves

Continuous improvement or Project Management training.
Writing or review of technical documents, preferably including regulatory filings (IND, MAA, BLA, PAS, CBE) and inspections with multiple agencies (FDA, EMA, JNDA).
Experience with large molecule analytical transfers.
Experience with commercial product analytical method changes.
Experience with assay monitoring and trending.

Responsibilities

Work with APLs to develop and implement the commercialization analytical strategy across testing nodes.
Participate in significant investigations across the viral vaccines franchise.
Provide Subject Method Expertise to QC analysts and supervisors, assess impact of proposed changes and deviations.
In partnership with the AWG and network QC labs, support definition of the opportunities for improvement/investment in equipment and technology required to drive assay modernization and implement harmonized network solutions. This includes working with our Digital manufacturing Division and LMAS team for assay digitization with harmonized data capture.
In partnership with the BCR hub, develop short and mid-term strategy for sustainability in BCR inventory and antisera generation needed to support all testing laboratories in the network and connect BCR performance with assay performance as noted above.
Provide SME support to APLC gap assessments of key methods to drive improved and sustainable robustness.
Ensure method performance data are presented, discussed and actions developed at analytical working group meetings as appropriate.
Collaborate across the internal network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) to ensure uninterrupted supply.
Escalate key assay challenges to management in a timely and concise manner.
Support RTQs, PAI readiness and audit observations.