Sr. Manager, Quality Control – Microbiology

Job Description

The schedule for this position is M-F Business hours (full time, on-site)

About This Role

The Sr Manager, Quality Control Microbiology will lead and manage the QC Microbiology team, ensuring efficient and effective operations. They will be responsible to oversee microbiological testing of raw materials, in-process samples, and finished products; develop team members and career paths; implement best industry practices; lead and participate in projects; participate in cross-site teams. Additional responsibilities include scheduling/balancing of team workload with respect to assignments/ personnel, management of key departmental milestones (data approval, schedules, deviations, etc.). The candidate will be responsible for adherence to procedures, global directives, quality systems and compliance.

What You’ll Do

• Oversee and give input to effective schedules, ensure completion of deliverables and activities.
• Communicate to teams regarding unplanned scheduling changes/issues, and escalate appropriately when timelines cannot be met (with mitigation plans when possible).
• Ensure team is focused on business and prioritization.
• Situational leadership-ability to flex and respond to unexpected situations/demands; effectively problem solve and reallocate resources as necessary.
• Provide leadership for QC initiatives as related to strategy of the business for example- cross site improvements, lead/participate to drive development of self and teams.
• Ensure completion of team activities including: reports, project representation (complex or those with significant impact) or project management (routine or minimal complexity).
• Coordinate activities with other departments; provide updates to QC team/mgmt., working closely with QA, MS, PQM, Regulatory, TD, Validation, QC VTR, etc.
• Supervise, hire and develop a well-functioning team – focusing on values and culture, while developing self. Ensure establishment of goals and development plans for employees. Hold one on ones, perform performance reviews and ensure routine feedback given to teams.
• Ensure training of team is deployed and curriculum maintained, as required.
• Ensure ability to conduct testing or activities that subordinates routinely execute.
• Other duties as assigned.

Who You Are

You enjoy working with people and providing leadership and guidance to others. You are independent with the ability to handle multiple projects and able to drive actions towards completion.

Qualifications

Required Skills

• Bachelor’s Degree in a life sciences related field
• Minimum 10 years of experience working in Quality Control Microbiology in a biotech/pharmaceutical GMP environment
• Minimum 5 years of experience supervising direct reports
• Deep understanding of QC Microbiology assays, including bioburden, endotoxin, and sterility
• Demonstrated project management skills
• Strong verbal and written communication skills

Preferred Skills

• Experience in sterile manufacturing
• Experience supporting in a Drug Product environment (preferred in parenteral filling and/or oral solid dose)

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.

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