Assoc Prin. Scientist, Analytical R&D

MSD•Upper Gwynedd Township, PA

1d•Hybrid

About The Position

The Associate Principal Scientist position will support our Live Virus Vaccines franchises. This broad role includes driving method alignment and supporting consistent executional excellence across multiple testing laboratories, maintaining a robust assay monitoring effort, supporting method procedure life cycle management including automation and/or modernization as applicable, and many other cross functional interactions. 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 technically complex molecular biology-based technologies and methods
Experience with analytical comparability.
Experience leading a cross-functional team.
Strong technical expertise in general large molecule analytical laboratory operations, equipment, and techniques.
Accountability
Adaptability
Analytical Method Development
Analytical Testing
Assay
Assay Development
Biochemical Assays
Biological Assay Development
Cell-Based Assays
Chromatographic Techniques
Collaborative Communications
Communication
Cross-Functional Teamwork
External Collaboration
GMP Compliance
High Resolution Mass Spectrometry (HRMS)
Liquid Chromatography-Mass Spectrometry (LC-MS)
Management Trainings
Mass Spectrometry Analysis
Molecular Biology
Optimistic Attitude
Process Analytical Technology (PAT)
Production Process Development
Project Management Training

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

Ensure execution of test methods is aligned and sustainable across multiple QC laboratories
Provide Subject Matter Expertise to QC analysts and supervisors, assess impact of proposed changes and deviations.
Responsible for assay monitoring ensuring 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 of LVVs
Coordinate with analytical and process development groups to prepare for and coordinate analytical troubleshooting, validation and technology transfers between Company sites as well as and CMO/CROs
Provide input into cross-functional teams and ensure alignment with analytical strategies and Quality Systems in support of analytical procedure life cycle management.
Act as subject matter expert informing development and optimization of existing 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.
Escalation of key assay 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.
Support RTQs, PAI readiness and audit observations