Associate Principal Scientist, Analytical R&D

MSD Malaysia; West Point (PA); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays

Vacation days

Sick days

Job summary

Merck & Co. in the United States is seeking a senior professional to oversee late-stage method development, validation, and life-cycle management of analytical methods, with a focus on global method transfer activities within the Global Quality Large Molecule Analytical Sciences (GQ-LMAS) organization.

The role interfaces with a global network of product manufacturing/testing sites, collaborating with development groups and research labs, driving continuous improvement and regulatory support for

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
• 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

Skills

Adaptability

Analytical Method Development

Analytical Thinking

Process Validation

Cross-Functional Teamwork

Regulatory Documentation

Project Management

LC-MS

Education

Bachelor’s degree in biology, chemistry, biochemistry, or related science

Master’s degree in biology, chemistry, biochemistry, or related science

PhD in biology, chemistry, biochemistry, or related science

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.

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)
• 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)

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}

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is $142,400.00 - $224,100.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.

• medical
• dental
• vision healthcare
• other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

The application deadline for this position is stated on this posting.

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: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): NA

Job Posting End Date: 09/17/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.