Senior Scientist - Supply Analytical Sciences (SAS)

Merck; New Jersey; On-site; USD 120,000 - 180,000; Full time

Job summary

Merck is seeking a highly skilled analytical chemist to lead development, validation, and technical reporting for pharmaceutical materials. You will design experiments, troubleshoot complex issues, and contribute to regulatory submissions.

Ideal candidates hold an MS in Chemistry (8+ years) or a PhD (2+ years) with extensive experience in analytical chemistry, chromatography, and spectroscopy. Travel may be required and a strong emphasis on data integrity is essential.

Qualifications

• Requires MS in Chemistry or related with 8+ years pharma development; PhD with 2+ years experience.
• Experience with analytical techniques for raw materials, intermediates, and drug substances.
• Strong communication skills and adaptability in a dynamic, cross-cultural environment.
• ALCOA+ data integrity principles knowledge; willingness to travel.

Responsibilities

• Author analytical procedures, development and validation protocols and reports.
• Perform investigations with strong technical troubleshooting skills.
• Providedocumentation during inspections and audits and maintain data integrity.
• Evaluate analytical methods for critical quality attributes of cGMP materials.
• Train staff on analytical techniques and problem solving.

Skills

Analytical thinking

Analytical Chemistry

Analytical Method Development

Data Integrity

Communication

Education

MS in Chemistry

PhD in Analytical Chemistry

Tools

Chromatography

Spectroscopy

Job description

Responsibilities

• Author analytical procedures, development and validation protocols and reports, technical reports, experimental designs, regulatory submission documents, etc.
• Perform investigations with strong technical troubleshooting skills.
• Provide documentation/technical input during inspections and audits (Regulatory and Internal) and have a working knowledge of data integrity.
• Evaluate analytical methods associated with the critical quality attributes of cGMP materials.
• Responsible for technical training of staff, as needed, on analytical techniques and problem solving once established within our department.

Qualifications

Required

• Master of Science (MS) in Chemistry or related discipline with at least eight (8) years of relevant pharmaceutical development experience; PhD in Analytical Chemistry or related discipline with two or more (2+) years of experience.
• Working knowledge of analytical techniques used in commercial testing of raw materials, intermediates, and drug substances.
• Strong verbal and written communication skills as well as flexibility to work in a dynamic environment (internal and external communications).
• Demonstrate strong interpersonal skills with flexibility and sensitivity in dealing with different cultures.
• Self-motivated to take ownership and accountability of issues and drive them to completion.
• Ability to quickly adapt to changes and develop appropriate plans for managing risks.
• Advanced knowledge of ALCOA+ principles.
• Must be able to travel on our company's behalf.

Preferred

• Advanced experience developing various analytical techniques (e.g., chromatography, and spectroscopy) and product specification to support drug substance development and registration.
• Fundamental knowledge of synthetic (organic) chemistry.
• Advanced experience with API development and commercialization from an analytical perspective.
• Advanced experience working with contract manufacturing organizations and/or contract research organizations.
• Advanced experience working in cross-functional teams.

Required Skills

• Adaptability
• Adaptability
• Analytical Analysis
• Analytical Chemistry
• Analytical Method Development
• Analytical Testing
• Analytical Thinking
• Chemical Proteomics
• Chemical Synthesis
• Chemistry
• Chemometrics
• Chromatographic Analysis
• Chromatography
• Commercialization
• Cross-Functional Project Management
• Data-Driven Decision Making
• Data Integrity
• Design of Experiments (DOE)
• Drug Delivery
• Drug Formulations
• Flow Cytometry
• Mass Spectrometry Based Proteomics
• Motivation Management
• Pharmaceutical Sciences
• Problem Identification {+ 10 more}

Equal Employment Opportunity & Diversity

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:

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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.

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Location and Compensation

The primary location for this posting is: USA - New Jersey - Rahway

Where required by law, the compensation range for