Principal Scientist

Insight Global are looking for an experienced Principal Scientist - Analytical to play a key role in our client’s Technical Operations Science and Innovation (TOSI) organization. TOSI provides technical support and expertise related to products, manufacturing, analytical, process engineering, statistics, modelling, devices, and testing.

The areas in which they deploy their technical expertise are in the support of drug product improvement projects, changes, technology transfers, investigations, regulatory responses, new submissions, product robustness, validation, risk, and manufacturability. This role works closely with many technical functions across Global Operations providing the ability to drive science and build capability within the organization and the ways of working.

Responsibilities:

• Responsible expert for a major commercial product or group of products related to the Analytical subject matter area e.g. Oral Solid Dosage formulations, parenteral formulations,
• Leadership and support for regulatory file authoring, review, license renewals and response to questions, including coaching colleagues with these activities.
• Provision of strong technical expertise & leadership to aid in the resolution of analytical method issues & complaints impacting supply.
• Development of suitable corrective and preventive actions in support of investigations.
• Responsible for the technical support during the transfer of established product analytical methods within sites and to external manufacturing partners including support for equivalency determination as applicable.
• Lead, assess impact & support complex technical improvements or change activities assuring product and methods performance.
• Responsible for analytical method lifecycle activities to ensure performance and compliance across sites.
• Identify opportunities for analytical method improvements.
• Provision of training in subject matter expertise areas.

Qualifications:

• Significant experience of preparing regulatory submission and responses to regulatory questions
• Excellent understanding of OSD products life-cycle, from launch and through life cycle management until discontinuation.
• Understanding of commercial product requirements in the areas of analytical methods establishment and optimization, control of drug products, biopharmaceutics, stability, trace analysis (e.g. elemental impurities, extractables & leachables).
• Significant experience in analytical methods optimization and transfer, including understanding of equipment and method capability and performance.
• Significant experience on issue investigation and change assessment from an analytical point of view. Good knowledge of standard tools for root cause analysis (5 whys, PPS, Level 0, etc…)
• A thorough understanding of principles, applications and management of SHE/EHS or HSE and cGMP.
• Evidence of excellent communication skills and build excellent relationships with customers.
• Experience in or exposure to multiple disciplines in CMC and related functions (eg Product Development, Operations, Global Supply, Marketing Companies)
• Strong leadership skills and behaviours with demonstration of being able to work across different functions/ countries/ cultures.
• Previous experience and training in Lean, problem-solving tools and have experience in data analysis and interpretation.

Plusses:

• Master's Degree with 5 years of experience or PhD with 3 years of experience in a relevant industry such as pharmaceuticals
• Pharmacopeial experience; both general chapters and monographs (specific to the products they support)