Principal Scientist, Analytical Science & Technology (AST) - LOTTE BIOLOGICS USA, LLC

Position Summary

The Principal Scientist within the Analytical Science and Technology team is responsible for implementing strategic initiatives that will develop and integrate best practices in executing analytical method lifecycle activities for the testing of raw materials, excipients, biologics and other modalities in-process, drug substance, and drug product samples.  The candidate will serve as a technical expert on analytical methodologies for a variety of instrumentation and techniques to support early-stage product development through commercialization efforts. The candidate will perform non-GMP testing, non-GMP stability testing, equipment qualification, reference standard qualification, and comparability studies.

Duties & Responsibilities

• Accountable for strategic execution of analytical activities (phase appropriate method validation, reference standard qualification, technical transfer strategy, analytical comparability, specification setting) required to advance and manage the analytical lifecycle of protein therapeutic programs.
• Create and maintain effective partnerships with stakeholders from Manufacturing Sciences and Technology, Quality, Project Management, Supply Chain, Regulatory, and Manufacturing to deliver analytical strategies with a high probability of technical and regulatory success.
• Provide strong technical leadership and understanding of the product process to lead multidisciplinary teams on projects and during complex method troubleshooting, investigations, technical transfers, and method validations.
• Lead the effort to implement effective change control strategies for analytical methods and specifications.
• Serve as an analytical expert during global Health Authority and client site inspections. Author and review CMC analytical sections of regulatory filings (IND, IND amendment, BLA, MAA, PAS, etc.) and prepare responses as required.
• Actively mentor others to facilitate growth of less experienced scientists. Arise as a functional leader who positively influences culture and values. Focus on inclusivity and safety to produce high quality, compliant results.
• Leverage Quality Risk Management principles to facilitate risk-based decision-making.
• Ensure Operational Excellence and drive novel solutions to improve the ability of the team to deliver on its objectives.
• Remain engaged with current industry standards, technology, trends, and regulatory expectations.
• Perform routine laboratory activities including sample management, instrument maintenance and calibration, sample testing, inventory and ordering of supplies, general housekeeping, and other related activities.

Knowledge, Skills, Abilities

• Strong verbal, written, presentation, and interpersonal communication skills with ability to adapt communications to the audience, clearly articulate scientific objectives and results, lead discussions, build alignment, and make recommendations in multidisciplinary meetings.
• Strong ability to think strategically, and to translate strategy into action to prioritize, provide clear direction to team members, and manage resources to complete project deliverables.
• Highly proficientin analyzing and interpreting data to draw appropriate conclusions, identify risks, and recommend potential solutions to ensure successful scientific, compliance and regulatory outcomes.
• Highly proficientin writing formal reports/documents and technical presentations.
• Demonstrated talent as a functional mentor/technical point of contact and highly proficient in effectively training others.
• Demonstrated achievement in continuous improvement initiatives leveraging lean principles and operational excellence.

Education & Experience

• B.Sc./B.Eng. in Biology, Chemistry, Biotechnology, or equivalent area of related study with 10-12 years, M.Sc./M.Eng. with 5-7 years, or Ph.D. with 2-4 years, of industry experience in biologic/protein analytics.
• In-depth experience across the analytical method lifecycle in protein biotherapeutics for a variety of methodologies and instrumentation used in the testing and characterization of raw materials, excipients, in-process, drug substance, and drug product samples including HPLC/UPLC methods and various other analytical techniques (i.e., qPCR, ELISA, CE-SDS, iCIEF, SDS-PAGE, UV-VIS, western blotting, mass spectrometry, and cell-based assays) is required.
• Advanced knowledge and experience in the biopharmaceutical development process, GMP, PAT, CMC and regulatory guidance, ICH guidelines, compendial requirements, and experimental statistical design/data analysis is required.
• Proven expertise in leading analytical change controls within a Quality Management System and ensuring all required test data and reports are available to support and justify the change(s) is required.
• Proven expertise in authoring, validating, and coordinating timely transfer of test methods with and to Quality Control laboratories is required.
• Experience in conducting and overseeing analytical comparability assessments, ensuring robust evaluation of critical quality attributes and method performance across different manufacturing processes or product lots is required.
• Experience defining the analytical control strategy and authoring complex technical CMC documents to support lifecycle management of Biological License Applications (BLA), Marketing Authorization Applications (MAA), Rest of World (ROW), and Post Approval Submissions (PAS) is preferred.
• Experience coordinating the specifications development process, preparing the justification of specification documents, and driving the process for internal and regulatory approval of the specifications is preferred.

Work Environment

• Position is primarily laboratory and office based with occasional work in a classified GMP manufacturing environment.
• Dynamic, fast-paced, interactive, and entrepreneurial environment. 
• Position is a team and project-based position that may require occasional shift work, weekends, and holidays.

Physical Demands

• The role is a combination of laboratory and office-based work.
• The laboratory work requires appropriate levels of personal protective equipment (PPE). The role may require contact with biohazardous materials such as live cell cultures and other hazardous chemicals including methotrexate, acids, and caustics. Powdered materials and high temperature liquids and solids may also be handled. Use of a respirator may be required.
• Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, sitting, kneeling, climbing on stepstools, and reaching may be required. Repetitive use of arms/hands/wrists and grasping may be required.
• The role may require unassisted lifting (not to exceed 50 lbs.).

Supervisory Responsibilities 

• May require supervisory responsibility of up to 5-7 direct reports. Demonstrated leadership experience is required.

Travel

• This position may require up to 10% of domestic and/or international travel.