Lead Scientist, Analytical Transfer - Large Molecules

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

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