Associate Principal Scientist, Analytical R&D

Merck Gruppe - MSD Sharp & Dohme

Northern (KY)

Hybrid

USD 142,000 - 224,000

Full time

3 days ago

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Benefits offered by this job

Hybrid work arrangement

Competitive salary

Job summary

Merck Gruppe - MSD Sharp & Dohme is seeking an experienced professional to lead complex analytical transfers for large molecule programs, including ADCs, mAbs, and vaccines. The role focuses on late-stage method transfer, validation, life-cycle management, and cross-functional collaboration across global sites.

Candidate will interface with manufacturing, development, and external partners to ensure successful assay commercialization, while driving continuous improvement in analytical

Qualifications

Experience in method transfer, validation, and QC in a CGMP environment.
Familiarity with ICH, USP, and regulatory filings related to vaccines and biologics.
Ability to lead cross-functional teams and manage timelines.

Responsibilities

Lead complex analytical transfers for ADCs, mAbs and vaccines.
Oversee method transfer/validation across programs with risk assessments.
Interface with internal/external partners to ensure assay commercialization.
Develop, troubleshoot, and optimize analytical methods.
Drive continuous improvement and lifecycle management of methods.
Support regulatory filings and launch activities for vaccines/biologics.

Skills

Adaptability

Analytical thinking

Analytical method development

Assay development

Cross-functional teamwork

Project management

Communication

Education

Bachelor's degree

Master's degree

PhD

Job description

Global Quality Large Molecule Analytical Sciences (GQ- LMAS) – Analytical Transfer Team

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in customer facing commercial or research based roles, will be required to be fully vaccinated as a condition of employment.

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

Global Quality Large Molecule Analytical Sciences (GQ- LMAS), in our 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 involve oversight of late-stage method development, validation, and life‑cycle management of methods but mainly global method transfer activities.

Within the Global Quality Large Molecule Analytical Sciences (GQ- LMAS) organization, this Analytical Transfer Team include activities interfacing with a global network of product manufacturing and testing sites, collaborating with product development groups within our manufacturing division and our Research Laboratories division, continuous improvement of analytical methodology, assay validation, analytical technical transfer, and Biologics License Application preparation.

Responsibilities

Lead complex analytical transfers for the team including ADCs, mAbs and Vaccines
Lead method transfers and/or validations across vaccine and biologics programs including quality risk assessments/gap analysis.
Provide sponsorship of both in-line and pipeline analytical methods. The candidate will interface across our Company network and external partners to ensure the successful commercialization of assays promoting our pipeline programs.
Involvement in development, troubleshooting and optimization of analytical methods
Continuous improvement using laboratory standardization, lean laboratory, and six sigma methodology
Assay Life Cycle activities across various large molecule franchises and analytical platforms
Promote various vaccine and/or biologics registrations, launches, and troubleshooting activities external to the US, including documentation preparation
Direct strategic initiatives within departmental and cross‑functional teams representing Global Quality Large Molecule Analytical Sciences (GQ- LMAS).
Manage global registration and test on importation (TOI) activities
Collaborating with commercial manufacturing teams to support facility start‑up activities, New Product Introduction and provide analytical support both within our Company network and at contract manufacturing organizations (CMOs) or contract testing laboratories

Education

Bachelor’s degree in biology, chemistry, biochemistry, or related science with six years of relevant industry knowledge in systematic development, validation, and/or quality control (QC) or
Master’s degree in biology, chemistry, biochemistry, or related science with four years of relevant industry knowledge in systematic development, validation, and/or quality control (QC) or
PhD in biology, chemistry, biochemistry, or related science with one year of relevant industry knowledge in systematic development, validation, and/or quality control (QC)

Knowledge | Skills

Knowledge of ICH, USP and other compendial chapters required for method transfer and validation.
Knowledge with late‑stage method development, validation, and transfer
Minimum two years working knowledge in a current Good Manufacturing Practices (cGMP) laboratory environment in large molecules (vaccines, biologics)
Development and management of project timelines and deliverables
Participation in cross‑functional project teams
Authoring and review of technical documents
Ability to work objectively and within a cross‑functional team
Ability to learn new techniques
Technical, verbal, and written communications, stakeholder management, and teamwork skills
Self‑motivated with a positive attitude and proven performance record
Knowledge with drug substance and drug product release, stability, and extended characterization testing for vaccines and biologics
Strong organizational and project management skills
Ability to effectively identify and express risks

Preferred

Deviation management and change control processes
Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ)
Global launch or supply experiences
Supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA)
Continuous improvement or lean six sigma methodology

Required Skills:

Adaptability, Adaptability, Analytical Analysis, Analytical Method Development, Analytical Thinking, Assay Development, Biological Assay Development, Cell-Based Assays, Change Controls, Change Management, Chromatographic Techniques, Collaboration, Commercialization, Competency Management, Cross-Functional Teamwork, External Collaboration, High Resolution Mass Spectrometry (HRMS), Learning Agility, Liquid Chromatography-Mass Spectrometry (LC-MS), Mass Spectrometry Analysis, Optimism, Process Analytical Technology (PAT), Process Verification, Project Delivery, Project Leadership {+ 9 more

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 if you need an accommodation during the application or hiring process.

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.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License: