Primary duties of this position will include serving as a lead for various technical aspects of the QC areas. Position will provide both subject matter expertise as well as technical leadership on activities such as method related projects (ex. method transfers and validations), and cross-functional interaction on various teams to enable appropriate overall QC support on projects and programs, as well as external coordination to contract organizations. Position will also assist in managing departmental and/or cross-functional teams occasionally.
Works autonomously and receives general instructions on new assignments.
Proposes technical strategies and frequently discusses soundness of technical judgment and reviews progress in meeting objectives and timelines with supervisor.
Operates under compliance requirements. May independently refer to or seek guidance on policies and practices.
Exerts some influence on the overall objectives and long-range goals of the organization. Erroneous decisions or failure to achieve objectives would normally have a serious effect upon the administration of the organization.
Specific QC Focus Areas:
Area is focused on various technical projects in support of the GMP laboratories, such as
but not limited too automation support, method projects activities (ex. method transfer and validation support activities method remediation and troubleshooting, method monitoring), critical reagents and reference standard programs, global technical oversight program, cell bank adventitious agent safety testing.
Requires knowledge and proficiency in the design, execution, and validation of analytical techniques used in the laboratory such as experience in bench chemistry including low complexity (pH, osmolality), and mid-complexity (Karl Fisher titration, Automated titration, Manual titration)techniques. Additonally, some technical writing skills are a helpful skill as well as knowledge of the major compendia (USP, EP, JP). Ability to troubleshoot method performance and propose corrections is essential.
Understands and applies advanced scientific principles, theories, concepts, practices and standards to process and product development. Keeps current with scientific knowledge in areas of expertise. Provides input to the development of new scientific knowledge.
Stands accountable and systematically operates with the desired outcomes in mind to consistently deliver high quality results for work assignments and personal objectives.
Effectively plans activities and anticipates difficulties in delivering results.
Nurtures network built on trust and respect beyond immediate circle of established relationships. Gains quick access to relevant parties and information using effective communication.
Addresses partners’ business issues and concerns beyond immediate needs. Assimilates different points of view to enhance collaboration. Is an active and reliable team player.
Actively seeks ways to improve current systems and processes related to own activities.
Maintains focus and professionalism amongst frequently changing situations, circumstances and priorities.
Proactively and systematically seeks and applies best practices for problem-solving and gap identification beyond one’s comfort level. Expands problem-solving abilities by assimilating new effective approaches.
Understands company business, objectives and operations and how own activities fit within the company strategy.
Applies knowledge of product development and biotech industry to decision making and proactively reaches out to others for perspective and guidance.
MS Office, LIMS, SAP, Trackwise, compliance and strong science understanding
Education and Experience Requirements
BA/BS in relevant scientific discipline with a minimum of 8 years relevant industry experience.
Additional Specific Experience:
Technical expert in one or more analytical technologies.
Knowledge of theories, principles and techniques of relevant scientific areas and basic understanding of industry practices and standards.
Excellent communication, interpersonal and organizational skills.
Proactive at keeping current with literature and latest technologies.
Ability to work well both independently and in a team environment.
Ability to prioritize work and multitask.
Conducts work in compliance with cGMPs, safety and regulatory requirements.