Manager, Analytical Development

Role Summary

Manager of Analytical Development will lead the design, development, and validation of analytical methods. The role is critical in advancing innovative therapies from concept throughout clinical development, ensuring product quality throughout its lifecycle, regulatory compliance, and alignment with company goals.

Responsibilities

• Lead analytical development activities for new drug product developments applying a systematic, proactive Analytical Quality By Design (AQbD) approach and using an outsourced development model. The AQbD approach must utilize prior and scientific knowledge and be an iterative, systematic strategy integrating proactive risk assessment, emphasizing continuous improvement to mitigate potential quality issues early to ensure analytical methods are robust, reproducible, and regulatory-compliant throughout the product lifecycle. AQbD aligns with the principles outlined in ICH Q14.
• Design and optimize analytical methods to appropriately measure and to evaluate potential drug product Critical Quality Attributes (CQAs) and the relationship between formulation Critical Materials Attributes and the drug product Critical Quality Attributes (CQAs).
• Contribute to the drug product specification development
• Collaborate with cross-functional teams including Formulation Development, Regulatory Affairs, Clinical, and Manufacturing.
• Ensure adherence to cGMP, FDA, DEA, and other regulatory standards.
• Manages and plans the activities for AD analytical and microbiology testing.
• Conduct investigations, deviations and change controls as needed.
• Prepare technical documentation, including development reports, regulatory submissions, and presentations.
• Evaluate emerging technologies and scientific advancements to enhance analytical strategies.
• Interface with external partners, CDMOs, and academic collaborators to support development efforts.
• Identify and mitigate risks in formulation development projects.
• Review the emerging stability data and contribute to expiration dating for clinical trial supplies.
• Support the release testing of clinical trial supplies.
• Lead analytical method validation activities.
• Lead analytical method transfer activities.
• Post-Approval Drug Product Support ‚Äì Apply prior knowledge and Subject Matter Expertise in partnership with Supply and Quality Assurance to support Indivior‚Äôs existing commercial drug products where applicable to include:
• Support timely and effective investigation and closure of deviations and out of specifications,
• Review the emerging ongoing stability data for compliance with registered specifications.
• Undertake analytical methods review and look for continuous improvement opportunities.
• Ensure from a CMC perspective the consistent quality, safety, and efficacy of the drug product during Post-Approval Changes (PACs) that include modifications to the manufacturing processes, analytical methods, stability testing, and formulation. These changes may require regulatory approval, depending on their nature and potential impact on the drug product's quality, ensure that the required supporting CMC information (e.g., comparability assessment, a risk-based approach, etc) is generated to support the change.
• Responsible for the direct analytical technical management of the 3rd party contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) as part of the outsourced CMC development model.
• Work effectively with other personnel throughout the company to meet timelines and milestones.

Qualifications

• A degree in Chemistry is preferred; Need a scientific degree
• A minimum of 8 years of experience in the pharmaceutical product research or development is required
• Pharmaceutical principles, practices and their application. Pharmaceutical and instrumental analyses and testing principles, techniques, applications and equipment

Skills

• Experienced with current Good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP), Food and Drug Administration (FDA), and other regulatory requirements
• Management of extremely technically challenging projects in a fast paced, GLP and GMP pharmaceutical development environment
• Analyzing problems, projecting consequences of proposed actions, and implementing recommendations that support department goals and objectives
• Planning, implementing goals, objectives and practices for effective, efficient and cost-effective management of allocated resources.
• Proven experience and practical knowledge in analytical development and/or QC.
• Experience of working with 3rd party partners to deliver project goals.
• Results orientated, self-motivated with an ability to evaluate and take risks.
• Strong analytical skills with the ability to think strategically to develop tactics and transform ideas into reality.
• Excellent communication skills and a proven ability to negotiate.
• Proven ability to work under pressure, as part of a team, without compromising quality and delivery.
• Communicating clearly and concisely, both orally and in writing. Establishing and maintaining effective working relationships with others. Managing and organizing multiple projects and assignments

Education

• Not specified beyond degree requirements in Chemistry or related scientific field