Principal Analytical Scientist, Analytical Commercialization, Development and Supply

Job Description

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 drive innovation in instrumentation and methodologies to enable efficient solutions to solve analytical problems within a regulated supply environment.

Responsibilities include but are not limited to:

• Lead and oversee analytical investigations with a strong focus on quality and regulatory compliance.
• Excel in 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
• Introduce and lead strategic initiatives related to technical advancement compliance and business improvements.
• Demonstrate the ability to influence meaningful outcomes through leadership and collaboration.
• Maintain a deep understanding of the regional regulatory and business environment including:
  • API and Drug Product development needs
  • GMP compliance in commercial manufacturing
  • Data integrity principles
• Coach and mentor staff on analytical techniques problem solving and data integrity as needed.
• Share best practices across the company to enhance overall capabilities.
• Report to the SAS E2E Investigation Support lead.
• Bring a strong technical background combined with superior problem-solving skills and an innovative mindset.
• Exhibit exceptional leadership abilities and strong knowledge of cGMP and Data Integrity.
• Uphold strong values essential to fostering and contributing towards the company vision.

Minimum Education Requirement and Experience:

• Bachelor of Science (BS) degree in chemistry or related sciences with twelve (12) years of combination experience in the following: technical background in analytical chemistry and instrumentation experience in leading and overseeing analytical investigations in a regulated environment and leadership experience in the pharmaceutical manufacturing industry OR

• Master of Science (MS) degree in chemistry or related sciences with ten (10) years of combination experience in the following: technical background in analytical chemistry and instrumentation experience in leading and overseeing analytical investigations in a regulated environment and leadership experience in the pharmaceutical manufacturing industry OR
• Ph.D. degree in chemistry or related sciences with six (6) years of combination experience in the following: technical background in analytical chemistry and instrumentation experience in leading and overseeing analytical investigations in a regulated environment and leadership experience in the pharmaceutical manufacturing industry

Required Skills and Experience:

• 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.
• Experienced in trace impurity quantitation impurity isolation and structure characterization.
• Provide documentation/technical input during inspections and audits (Regulatory and Internal) and have a working knowledge of data integrity and recent industry trends.
• Identify and champion continuous improvement for the existing workflows.
• Have a working knowledge of API and Drug Product development and commercialization and understand the needs related to commercial quality control.
• Have working knowledge of developing various analytical techniques (e.g. chromatography mass spectrometry spectroscopy) and product specification to support drug substance and drug product initiatives.
• Have working knowledge of the process by which the products are brought to market.
• Demonstrate strong collaboration with cross-functional partners both internally and externally and skill to influence outcomes.
• Have experience working with CMOs and CROs.
• Have a working knowledge of CMC filing requirements.
• Demonstrate strong verbal as well as written communication skills and ability to work in an interdisciplinary team environment.
• 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.
• The ability to speak up and raise issues and help to drive resolution.
• The ability to quickly adapt to changes and develop appropriate plans for managing risks.

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

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 can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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