
Senior Principal Scientist, Regulated Bioanalytics
Welcome to Merck & Co., where we are dedicated to making a difference in the lives of people around the world. We are currently seeking a highly motivated and experienced Senior Principal Scientist to join our Regulated Bioanalytics team. As a global leader in healthcare, we are committed to developing innovative and life-changing medicines and vaccines. In this role, you will have the opportunity to lead and execute bioanalytical strategies for regulated drug development programs, contributing to the advancement of our mission. We are looking for a candidate with extensive experience in bioanalysis and regulatory compliance, strong leadership skills, and a passion for making a positive impact on human health. If you are driven, collaborative, and have a track record of success in a regulated environment, we welcome you to apply for this exciting opportunity with Merck & Co.
- Develop and lead bioanalytical strategies for regulated drug development programs.
- Ensure compliance with all applicable regulatory guidelines and requirements.
- Collaborate with cross-functional teams to design and execute bioanalytical studies.
- Oversee the development, validation, and implementation of bioanalytical methods.
- Analyze and interpret data to support decision-making and drive the development of innovative medicines and vaccines.
- Provide technical expertise and guidance to junior scientists and project teams.
- Review and approve study protocols, reports, and regulatory submissions.
- Stay current with industry trends and regulatory updates to inform bioanalytical strategies.
- Maintain and manage relationships with external partners and vendors.
- Foster a culture of continuous improvement and innovation within the Regulated Bioanalytics team.
- Act as a key contributor to the global bioanalytical community within Merck & Co.
- Represent the company at conferences, meetings, and regulatory interactions.
- Drive effective communication and collaboration with internal stakeholders, including senior leadership.
- Promote a culture of compliance and ethical conduct within the team.
- Contribute to the overall success of the company by continuously striving for excellence in bioanalytics and drug development.
Advanced Degree In A Scientific Field, Preferably In Biochemistry, Molecular Biology, Or Related Discipline.
Minimum Of 10 Years Of Experience In Regulated Bioanalytics, Preferably In A Pharmaceutical Or Biotech Industry Setting.
Extensive Knowledge Of Regulatory Guidelines And Requirements For Bioanalytical Method Development And Validation, Including Fda, Ema, And Ich Guidelines.
Proven Track Record Of Successfully Leading And Managing A Team Of Scientists And Overseeing Multiple Projects Simultaneously.
Strong Communication And Collaboration Skills, With The Ability To Effectively Communicate Complex Scientific Concepts To Both Technical And Non-Technical Stakeholders.
Project Management
Data Analysis
Quality Control
Validation protocols
Scientific writing
Team Leadership
Regulatory compliance
Method development
Biomarker
Bioanalytical Expertise
Gmp/Gcp Regulations
Communication
Conflict Resolution
Leadership
Time management
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving
Empathy
According to JobzMall, the average salary range for a Senior Principal Scientist, Regulated Bioanalytics in West Point, PA, USA is $156,000-$188,000 per year. This may vary depending on the specific company, years of experience, and additional qualifications and skills.
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Merck & Co., Inc., d.b.a. Merck Sharp & Dohme outside the United States and Canada, is an American multinational pharmaceutical company and one of the largest pharmaceutical companies in the world. Merck & Co., Inc. engages in the provision of health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products. It operates through the following segments: Pharmaceutical, Animal Health, Alliances and Healthcare Services. The Pharmaceutical segment includes human health pharmaceutical and vaccine products marketed either directly by the company or through joint ventures.

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