Associate Principal Scientist, Chemistry
Merck
6 hours ago
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Responsibilities:
- Lead and/or perform analytical investigations with a strong focus on quality and regulatory compliance.
- Perform impurity isolation, unknown peak identification, characterization of degradation pathways, and trace impurity quantitation (e.g., carcinogens/mutagens such as nitrosamines).
- Utilize specialized instrumentation such as mass spectrometers and other spectroscopic techniques.
- Collaborate with internal company sites and Contract Manufacturing Organizations (CMOs) to:
- Identify issues and gaps
- Implement solutions to troubleshoot and optimize laboratory test methods, workflows, and materials
- Ensure a compliant, robust, and responsive supply chain
- Influence meaningful outcomes through leadership and collaboration.
- Maintain understanding of the regional regulatory and business environment, including API and Drug Product development needs, GMP compliance, and data integrity principles; demonstrate strong leadership and knowledge of cGMP and Data Integrity.
Minimum Education Requirement and Experience:
- BS in chemistry or related sciences with at least 10 years of combination experience, including strong analytical chemistry/instrumentation background and leading/performing analytical investigations in a regulated environment; OR
- MS in chemistry or related sciences with at least 8 years of combination experience (as above); OR
- PhD in chemistry or related sciences with at least 4 years of combination experience (as above).
Required Skills and Experience:
- Working knowledge of developing analytical techniques (e.g., chromatography, mass spectrometry, spectroscopy).
- Author analytical procedures, method development/validation/transfer protocols and reports, technical reports, experimental designs, and regulatory submission documents.
- Technical troubleshooting skills; assist in developing/implementing CAPAs.
- Working knowledge of trace impurity quantitation, impurity isolation, and structure characterization.
- Strong verbal/written communication and interpersonal skills; ability to work in interdisciplinary teams.
- Ability to influence team direction in complex situations and navigate ambiguity.
- Adapt quickly to changes and manage risks.
- Strategic thinking; articulate the “big picture” and ask the right questions.
- Self-motivated with ownership/accountability to drive issues to completion.
- Experience working with CMOs and CROs.
Preferred Skills and Experience:
- Working knowledge of pharmaceutical drug substance and/or drug product development and commercialization.
- Working knowledge of CMC filing requirements and regulatory guidance (e.g., ICH) for drug substance and/or drug product.
- Working knowledge of GMP, data integrity, and recent industry trends in commercial production.
Benefits (if applicable in posting):
- Eligible for annual bonus and long-term incentive (if applicable).
- Comprehensive benefits including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days.
Application Instructions:
- Apply through https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee). Application deadline is stated on the posting.
- Lead and/or perform analytical investigations with a strong focus on quality and regulatory compliance.
- Perform impurity isolation, unknown peak identification, characterization of degradation pathways, and trace impurity quantitation (e.g., carcinogens/mutagens such as nitrosamines).
- Utilize specialized instrumentation such as mass spectrometers and other spectroscopic techniques.
- Collaborate with internal company sites and Contract Manufacturing Organizations (CMOs) to:
- Identify issues and gaps
- Implement solutions to troubleshoot and optimize laboratory test methods, workflows, and materials
- Ensure a compliant, robust, and responsive supply chain
- Influence meaningful outcomes through leadership and collaboration.
- Maintain understanding of the regional regulatory and business environment, including API and Drug Product development needs, GMP compliance, and data integrity principles; demonstrate strong leadership and knowledge of cGMP and Data Integrity.
Minimum Education Requirement and Experience:
- BS in chemistry or related sciences with at least 10 years of combination experience, including strong analytical chemistry/instrumentation background and leading/performing analytical investigations in a regulated environment; OR
- MS in chemistry or related sciences with at least 8 years of combination experience (as above); OR
- PhD in chemistry or related sciences with at least 4 years of combination experience (as above).
Required Skills and Experience:
- Working knowledge of developing analytical techniques (e.g., chromatography, mass spectrometry, spectroscopy).
- Author analytical procedures, method development/validation/transfer protocols and reports, technical reports, experimental designs, and regulatory submission documents.
- Technical troubleshooting skills; assist in developing/implementing CAPAs.
- Working knowledge of trace impurity quantitation, impurity isolation, and structure characterization.
- Strong verbal/written communication and interpersonal skills; ability to work in interdisciplinary teams.
- Ability to influence team direction in complex situations and navigate ambiguity.
- Adapt quickly to changes and manage risks.
- Strategic thinking; articulate the “big picture” and ask the right questions.
- Self-motivated with ownership/accountability to drive issues to completion.
- Experience working with CMOs and CROs.
Preferred Skills and Experience:
- Working knowledge of pharmaceutical drug substance and/or drug product development and commercialization.
- Working knowledge of CMC filing requirements and regulatory guidance (e.g., ICH) for drug substance and/or drug product.
- Working knowledge of GMP, data integrity, and recent industry trends in commercial production.
Benefits (if applicable in posting):
- Eligible for annual bonus and long-term incentive (if applicable).
- Comprehensive benefits including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days.
Application Instructions:
- Apply through https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee). Application deadline is stated on the posting.