Associate Principal Scientist, Chemistry

MSD • Upper Gwynedd Township, PA

23h • 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.

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