Associate Principal Scientist, Analytical R&D

Merck; West Point (PA); On-site; USD 120,000 - 160,000; Full time

Job summary

Merck is seeking a senior analyst to lead complex analytical transfers for large molecule programs, including ADCs, mAbs, and vaccines. The role involves oversight of method transfers, validations, and life-cycle management across global teams.

Collaborate with product development, manufacturing, and testing sites, drive continuous improvement, and support regulatory documentation for biologics and vaccines in a fast-paced environment.

Qualifications

• 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)
• 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)
• PhD in biology, chemistry, biochemistry, or related science with one year of relevant industry knowledge in systematic development, validation, and/or quality control (QC)

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
• Interface across our Company network 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 and lean six sigma methodologies
• Assay Life Cycle activities across various large molecule franchises and analytical platforms
• Support facility start-up activities and analytical testing at CMOs or contract labs

Skills

ICH Knowledge

Method Transfer

cGMP Experience

Analytical Validation

Vaccine/Biologics

Project Management

Cross-functional

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 s