Job Description
About This Role:
As a visible member of the RTP Bio Site Leadership team as well as the Global Quality Control Leadership team, you will provide both strategic and operational leadership for the Bio Site Quality Control (QC) Operations organization. In this pivotal role, you will oversee a team dedicated to ensuring the highest standards of quality through chemical, biochemical, and biological analysis (immunoassay, bioassay, virology, microbiology) of various stages of drug substance and drug product material manufactured in our Small Scale, Large Scale, and Flexible Volume factories at RTP Bio. You will develop and manage QC budget plans and lead the management of laboratory quality systems, including analytical instruments & equipment, testing procedures, as well as assay controls & standards. Your contributions to overall site strategy, global milestone projects, and ensuring adherence to all regulatory requirements will all be in support of our clinical and commercial supply chain.
What You'll Do:
- Lead the Bio Site QC Operations organization - Management of effective and efficient cGMP compliant QC laboratory operations and effective partnership within Global Quality. Plan, implement and direct activities of QC Testing Lab supervisors and managers in core functions that include all types of sampling and testing activities; provide technical support as well as facilitation of major investigations; all in support of business and manufacturing schedules.
- Be accountable for QC personnel staffing, their training, development, and performance consistent with requirements of GMP compliant Quality Control operation. Ensure adherence to safety regulations and requirements.
- Participate in the RTP Bio Site Leadership team, contributing to organizational focus and strategic planning.
- Establish and maintain fully effective laboratory systems to ensure integrity of all laboratory results. Ensures tracking, trending are completed and evaluated for QC functions. Responsible for audits and site management review. Ensures tasks are completed to meet business initiatives within suitable timeframe.
- Collaborate with various teams including manufacturing, MFG Sciences, Technical Development, Quality Assurance, CMC, and Global Quality to facilitate cross-functional success.
- Develop and manage QC budget plans, ensuring financial discipline and alignment with company near and long-term growth strategies
- Manage key site and global milestone projects, maintaining adherence to all regulatory licenses and regulations.
- Provide technical support, facilitate major investigations, and ensure QC laboratory operations support business and manufacturing schedules.
- Drive compliance and quality by supporting analytical method and process validation, instrument qualifications, and adherence to safety regulations.
Who You Are:
You are a leader who thrives in a dynamic environment and possesses a strong background in Quality within the biotechnology manufacturing sector. You have a proven track record of leadership, with experience at both site and organizational levels. Your expertise extends to managing GMP-compliant QC operations and you are adept at strategizing to meet business needs. You are committed to developing your team, fostering a culture of safety and excellence. You understand the critical nature of your role and approach each challenge with a problem-solving mindset, ensuring the highest quality standards are upheld.
Qualifications
Required Skills:
- Bachelor's degree (B.S.) in Chemistry, Biochemistry, Biological Sciences, or a related field
- A minimum of 12 years of relevant experience, including people leadership, with a history of advancement and exposure at site leadership and organizational levels
- Strong understanding of GMP compliant Quality Control operations within a biotechnology setting
- Demonstrated ability in developing and managing budgets and QC infrastructure
- Proven track record of successful cross-functional collaboration and project management
- Expertise in laboratory systems, analytical methods, and compliance with regulatory requirements
Preferred Skills:
- Advanced degree in a related field
- Experience with strategic planning and execution in a global quality context
- Proficiency in data analysis, trending, and reporting within a QC framework
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
