Principal Scientist, Analytical Operations

Gilead Sciences•Edmonton, AB

1d•Onsite

About The Position

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Principal Scientist, Analytical Operations, you will assume a full-time employment role within Global Quality's Commercial Analytical Support group. The Principal Scientist will primarily assume a Quality Control (QC) lead role and will be responsible for the strategic oversight and operational execution of cGMP analytical testing in support of small molecule clinical development programs. The role provides leadership for assigned programs across a range of QC activities, ensuring that testing, documentation, and data integrity standards meet regulatory requirements and project deliverables. The ideal candidate will bring deep technical expertise in analytical chemistry and cGMP operations, a strong understanding of phase-appropriate quality control strategies and requirements, and the ability to collaborate cross-functionally to enable successful delivery of clinical supply and development milestones. This position will also involve leading cGMP analytical aspects of commercial small molecule APIs by managing analytical technology transfer activities to contract manufacturing organizations (CMOs), analytical support of commercial manufacturing at CMOs, and supporting regulatory activities (inspection readiness and support, regulatory responses, etc.).

Requirements

PhD in chemistry or related area and 5+ years of relevant experience OR MA/MS in chemistry or related area with 8+ years of relevant experience OR BA in chemistry or related area with 10+ years of relevant experience
10 + years of hands-on and leadership experience in small molecule pharmaceutical analytical testing and quality control.
Prior experience establishing analytical specifications and authoring CMC sections of regulatory submissions.
Strong understanding and application of cGMP principles, concepts, practices and standards
Deep understanding of regulatory and phase-appropriate QC expectations for clinical development.
Demonstrated experience managing testing activities at external testing laboratories and contract manufacturing organizations.
Excellent scientific judgement, communication, cross-functional collaboration, and influencing skills.
Demonstrated ability to organize, plan, and execute multiple tasks with flexibility for changing priorities and plans.
Must think critically and creatively and be able to work independently to determine appropriate strategies and resources for resolution of problems
Knowledge of medical devices and combination products

Responsibilities

Define, implement, and continuously improve the QC strategy for small molecule clinical development programs in alignment with overall CMC and quality objectives.
Serve as the point of contact for overall QC activities including method validation and transfer, reference materials, specifications, cGMP release testing, stability strategy and testing, and supervision of testing at external contract testing laboratories.
Develop and maintain phase-appropriate QC strategies and processes to support manufacturing and regulatory submissions
Responsible for the management and approval of specifications, collaborating cross-functionally to establish scientifically sound and phase-appropriate specifications aligned with analytical capability, process understanding, and clinical and regulatory expectations
Represent QC on cross-functional product development teams, providing technical input and direction for analytical and quality decisions.
Identify and drive opportunities for improvement in QC testing, workflows, data management, and compliance processes.
Proactively identify and escalate potential QC risks, and communicate QC activities, risks, and issues to relevant stakeholders
Oversee and ensure compliant execution of QC testing for raw materials, in-process, intermediates, drug substance, and drug product
Ensure timely creation, review, and approval of QC documentation including test methods, protocols, reports, CoAs, and quality records
Provide QC oversight to contract manufacturing organizations and testing laboratories, coordinating testing activities for on-time delivery and confirming compliance with cGMP and data integrity expectations
Direct and oversee timely resolution of QC testing related investigations with comprehensive root-cause analysis, risk assessment, and effective CAPAs
Advises members of project teams in the initiation and execution of GMP activities
Ensure QC operations comply with cGMP, FDA, EMA, ICH, and other applicable
Drive excellence in data integrity, documentation practices, and traceability across QC
Serve as a QC subject matter expert to draft and review CMC sections and supporting documents for regulatory filings and response to questions (RTQs).
Partner closely with Analytical Development, Manufacturing (Global External Manufacturing, Manufacturing Science and Technology), Quality Assurance, Regulatory, and Supply Chain to ensure seamless coordination of analytical strategy and QC testing support throughout the product lifecycle
Support technology transfer and method implementation at internal and external laboratories
Provide QC input into product development and regulatory submission documentation
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.