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), investigations, quality events, data analysis and trending, key program oversight (ex. reference standard program), 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.
- Demonstrates independent judgment in technique and method selection, protocol and study design and execution, data analysis and use of standard practices and procedures for a variety of problems of moderate scope and complexity to meet assigned objectives.
- Contributes to setting assignment objectives, plans and prioritizes activities. May manage moderately complex projects and initiatives.
- Designs and independently performs studies to troubleshoot issues encountered during development, or GMP manufacturing.
- May provide input on product design, development and project execution.
- Documents and reviews data as per established company guidelines and SOPs. Authors documents such as protocols, memos, data summaries, reports and procedures and contributes to publications and relevant CMC sections of regulatory filings.
- Writing typically requires revision.
- Presents issues and results at department and project team meetings. Presents at external meetings or publishes in peer-reviewed journals.
- Under general direction, designs and implements scientifically sound and creative solutions to a variety of problems of moderate scope and complexity to support company products.
- Supports overall department strategy within area of expertise.
- 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.
- Area is focused on various technical projects in support of the GMP laboratories, such as
- 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
Education & Qualifications
- BA/BS in relevant scientific discipline with a minimum of 8 years relevant industry 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.
- MS Office, LIMS, SAP, Trackwise, EDMS, compliance and strong science understanding
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance