Associate Principal Scientist, Microbiology Project Testing Lead AR&D

Merck • Upper Gwynedd Township, PA

4d • Hybrid

About The Position

Join us and experience our culture first-hand one of strong ethics & integrity, diversified experiences, exceptional science, and a resounding passion for improving human health. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

In your role as Associate Principal Scientist, you will be a critical part of the Analytical Research and Development Microbiology team with responsibilities including leading the rapidly growing pipeline via collaboration with stakeholders to deliver on critical data in a good manufacturing practices (GMP) microbiology laboratory including finished products testing, utilities, and environmental monitoring. While working within a fast-paced, integrated, multidisciplinary team environment, the candidate is expected to have a strong working knowledge of microbiology laboratory practices and procedures in a GMP environment including microbiology data review and quality procedures.

This position is based at the West Point, Pennsylvania site.

Requirements

• Minimum 4 years of pharmaceutical industry experience for applicants with a PhD degree; 8 years of experience with a MS degree, or 12 years of experience with a BS in Microbiology or related Biological Sciences, or equivalent with microbiological testing experience.
• A proven record of strong technical problem solving and laboratory experience.
• Excellent written and oral communication skills, as well as interpersonal skills, are necessary to qualify for this role.
• Extensive knowledge and experience of microbiology testing in context of, environmental monitoring, aseptic manufacturing, and finished product testing in a GMP environment
• Expertise in nonsterile and aseptic manufacturing and associated GMP product testing
• Experience in leading and supporting quality investigations in the microbiology discipline
• Experience with internal / external audit process and authoring responses to observations
• Knowledge of current microbiology industry guidelines and compendia
• Demonstrated ability to mentor, guide, and develop laboratory staff, fostering a collaborative and high-performance work environment.
• Proven experience in managing cross-functional teams and coordinating microbiology projects to meet deadlines and quality standards and ensuring teams meet timelines / deliverables.
• Strong decision-making skills and the capacity to lead by example, ensuring compliance with regulatory requirements and company policies.

Nice To Haves

• Experience with testing in clean room environments preferred
• Experience with MODA preferred

Responsibilities

• Lead the execution of microbiology finished product testing, utilities, and environmental monitoring in GMP environment
• Leverage QC microbiology expertise as a subject matter expert in support of sterile operations within the quality control department including isolator qualifications, sterility testing, biological indicator challenge tests, and method suitability, endotoxin, microbial enumeration, media / reagent quality control testing, mycoplasma.
• Drive experimental design, execution, and data interpretation of microbiology data.
• Oversee the execution, procedure, results, and conclusions of experiments in a detailed and organized manner following ALCOA and data integrity principle.
• Execute test method suitability studies and implement microbiology methods to support release and stability testing of small molecule, biologic, and vaccines finished drug products.
• Troubleshoot and lead any investigations associated with GMP testing through active collaboration with cross-functional project teams and/or Quality stakeholders. Identify appropriate corrective and preventative actions.
• Partner with internal stakeholders and partners including Quality, Pipeline, and Operations.
• Supervise microbiology testing, data entry, data review, and author /approve reports and data summaries.
• Conduct project management and/or scientific oversight of studies performed at Contract Laboratories
• Contribute expertise and creativity to the collective knowledge and aid in solving complex problems.
• Support internal and external compliance audit activities.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Principal