Associate Principal Scientist, Chemistry

Merck • Rahway, NJ

2d • Hybrid

About The Position

Our company is seeking an exceptional individual for a technical leadership position within the Supply Analytical Sciences (SAS) - Analytical Chemistry in Development and Supply (ACDS) organization located in the US. The successful candidate will be joining a group of innovative scientists with broad deliverables including, but not limited to, API and Drug Product analytical problem-solving and optimization, trace impurity quantitation, characterization studies, and cross-functional initiatives. The individual will also participate in innovating instrumentation and methodologies to enable efficient solutions to solve analytical problems within a regulated supply environment.

Requirements

• Bachelor of Science (BS) degree in chemistry or related sciences with at least ten (10) years of combination experience in the following: strong technical background in analytical chemistry and instrumentation and experience in leading/performing analytical investigations in a regulated environment OR Master of Science (MS) degree in chemistry or related sciences with at least eight (8) years of combination experience in the following: strong technical background in analytical chemistry and instrumentation and experience in leading/performing analytical investigations in a regulated environment OR Ph.D. degree in chemistry or related sciences with at least four (4) years of combination experience in the following: strong technical background in analytical chemistry and instrumentation and experience in leading/performing analytical investigations in a regulated environment.
• Working knowledge of developing various analytical techniques (e.g., chromatography, mass spectrometry, spectroscopy)
• Author analytical procedures, method development, validation and transfer protocols and reports, technical reports, experimental designs, and regulatory submission documents, etc.
• Perform investigations with strong technical troubleshooting skills and assist in developing/implementing CAPAs.
• Working knowledge of trace impurity quantitation, impurity isolation, and structure characterization.
• Strong communication (verbal and written) and interpersonal skills, demonstrated ability to work in an interdisciplinary team environment
• Ability to influence team direction for complex situations and navigate ambiguity
• Ability to quickly adapt to changes and develop appropriate plans for managing risks
• Strategic thinking and ability to articulate the “big” picture along with demonstrated ability in asking the right questions to drive critical conversations
• Self-motivated to take ownership and accountability of issues and drive them to completion.
• Experience working with CMOs and CROs.
• Analytical Chemistry
• Analytical Development
• Chemical Synthesis
• Chemistry
• Chromatography
• CMO Management
• GMP Compliance
• Mass Spectrometry (MS)
• Method Development
• Spectrometry

Nice To Haves

• 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 and data integrity and recent industry trends in commercial production space

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 closely with internal company sites and Contract Manufacturing Organizations (CMOs) within the manufacturing network 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
• Demonstrate the ability to influence meaningful outcomes through leadership and collaboration.
• Maintain a strong understanding of the regional regulatory and business environment, including: API and Drug Product development needs GMP compliance in commercial manufacturing Data integrity principles
• Exhibit strong leadership abilities and strong knowledge of cGMP and Data Integrity.
• Uphold strong values essential to fostering and contributing towards the company vision.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees