Principal Scientist – Biologics Potency, Cell Based Sciences, Analytical R&D Full-time

Senior Level Scientist, Analytical Research & Development, Cell Based Sciences

The Analytical Research & Development, Cell Based Sciences in Rahway, NJ is seeking a motivated senior level scientist with extensive experience in biologics potency assays.

Key Responsibility:

• Responsible for providing scientific leadership and mentoring, expertise, and creativity in defining potency strategies, method development and problem solving for complex projects across the large molecule portfolio.
• Oversight of developing MoA-reflective potency methods using innovative and state-of-the-art analytical techniques and approaches, and generation of technical reports
• Support method transfers to internal and external GxP laboratories
• Represent the potency group on cross-functional product development teams and effectively communicate with stakeholders in partner organization and to management and governance teams.
• Support regulatory filing by authoring and reviewing regulatory submissions and interacting with Health Authorities.

Education, Qualifications, and Skills:

• Ph.D. in cell biology, immunology, biochemistry, molecular biology, or related field with a minimum of 8 years of relevant industry experience; OR M.S. with a minimum of 10 years of relevant industry experience; OR B.S with a minimum of 14 years of relevant experience in the pharmaceutical industry.
• Expertise in applying advanced cell biology and immunology to solve complex scientific and operational challenges related to designing and developing GxP potency assays to support a variety of large molecule modalities. Experience in complex modality-based biologics development is a plus.
• Expertise in a variety of potency assay technologies, such as immune binding assays, cell line engineering, cell-based reporter gene assay development, flow cytometry, effector function assays.
• Strong knowledge and statistical skills for interpretation of potency data in context of broader process and product development.
• Working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing regulatory submissions and responses and interacting with Health Authorities.
• External scientific engagement including publications, industry white paper contributions, presentations at scientific meetings, membership on (or leading) cross-company working groups or consortia.
• Ability to excel in a team-based environment, partnering and influencing in a professional and positive manner.
• Excellent verbal and written communications skills

The salary range for this role is $153,800.00 – $242,200.00. 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. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.