Primary duties of this job include: serving as a Global QC lead for the cross-functional interaction on various program teams to enable appropriate QC support; partnering and setting QC strategies with product teams and QC functions for CMC activities; coordinating critical QC activities within QC and with other functions (including Process and Analytical Development, QA, Regulatory, Manufacturing, and CMOs); and maintaining timelines to deliver QC commitments for product development, quality by design initiatives, and life cycle management.
Position will provide subject matter expertise as an technical advisor and a coordinator for various technical aspects of the QC activities, such as method related projects (ex. method transfers and validations), investigations, quality events, data analysis, trending, key program oversight (ex. reference standard program), as well as external coordination to contract organizations. Position will also assist in managing departmental and/or cross-functional teams occasionally.
Designs technical strategies with the supervisor, and regularly reports to supervisor on progress in meeting objectives.
Understands and follows compliance requirements and independently refers to policies and practices for guidance.
Effects of decisions are long-lasting and heavily influence the future course of the organization. Errors in judgment or failure to achieve results would result in the expenditure of large amounts of company resources.
Specific QC Focus Areas:
Position is focused on coordination and management of QC-related deliverables for the development and life cycle management of selected products in collaboration within QC and outside QC functions, product teams, and, as needed, CMOs.
Product team participation for commercial product investigations and analytic life cycle management; designs, manages, and executes analytical methods (includes internal and external execution) to supportinvestigations; coordination and management of with QC and QC collaborators; technical review and preparation of associated protocols/reports; quality systems, regulatory support
Provides technical expertise on method performance monitoring, assay remediations, validation strategies, and analytical technologies; Provides subject matter expertise as a technical advisor for various technical aspects of the QC activities and procedures.
Contributes to team building, performance improvements in QC, Provide organizational/strategic feedback/insight from the point of program management.
Education and Experience Requirements:
BA/BS in relevant scientific discipline with a minimum of 10 years relevant industry experience. Ph.D., M.S. or B.S. in Analytical Chemistry, Biophysical, Biochemistry, Biology, Pharmaceutical Sciences or related field with 2-5years, 5+ and 10+ years, respectively, of experience in Analytical Development or Quality Control with experience in projects/programs supporting investigations.
Additional Specific Experience:
Technical expertise in multiple analytical technologies (e.g., HPLC, UPLC, LC-MS, ELISA, cell based assays, etc), establishing recognition outside the company.
Knowledge of theories, concepts, principles and techniques of relevant scientific areas.
Proficiency in current biotechnology industry practices, techniques, and standards.
Excellent communication, interpersonal, organizational and priority/time line management skills.
Ability to work well both independently and in a team environment for multiple projects.
Conducted work in compliance with safety and regulatory requirements.
Applies advanced scientific principles, theories, concepts, practices and standards to investigations and processes. Keeps current with scientific knowledge and technologies in areas of expertise. Advances scientific knowledge in own area of expertise with the development of new concepts, techniques and standards.
Strong interpersonal and communication skills required with demonstrated abilities to influence internally/externally and cross-functionally. Demonstrated leadership skills in planning, delegating and managing projects and priorities. Self-motivation and great teamwork in fast-paced and result-driven environment essential. Critical thinking and problem solving skills.
Stands accountable, prioritizes activities and effectively plans for contingencies to systematically deliver high quality results for work assignments and personal objectives. Finds creative and effective ways to ensure achievement of desired outcomes despite difficulties. Understands and uses systematic approaches to risk assessment and management.
Effectively leverages and continuously expands network of internal and external relationships built on trust and respect. Leads by example in effective, open-minded and inclusive communication and collaboration. Understand and anticipates partners’ needs and is an active and reliable team player.
Actively seeks ways to improve current systems and processes beyond those closely related to own activities.
Maintains focus and professionalism amongst frequently changing situations, circumstances and priorities. Consistently learns from new or difficult situations.
Exemplifies and promotes best practices for problem-solving and gap identification in activities for self and collaborators. Expands problem-solving abilities by assimilating and championing new effective approaches from internal and external sources.
Understands Shire’s business, objectives and operations and how team activities fit within the company strategy and relate to industry trends.
The following physical abilities are required in order to fulfill the job duties:
– Ability to walk (transport), sit and stand for periods of time
– Ability to work using a computer and a phone
Some travel expected; both regional and international. Travel between sites is required.
Individual may be required to support some work in a lab which requires ability to work around chemicals, and ability to wear personal protective equipment such as gloves and gowning.
Req ID: R0021383