Senior Associate I, Quality Control Microbiology

Job Description

About This Role:
As a Senior Associate I in Quality Control Microbiology, you will play a pivotal role in Biogen's state-of-the-art manufacturing facility located in Solothurn, Switzerland. Your expertise in microbiological analysis will be vital to the integrity of our drug substances and utilities. This role involves a spectrum of responsibilities including microbial identification, endotoxin testing, and growth promotion tests. Your efforts will directly contribute to the quality of Biogen's products and uphold our commitment to patient safety. In addition to hands-on testing, you will also be instrumental in instrument qualification and method validation, ensuring our practices align with industry standards. As a senior member of the team, you will champion change controls, lead TrackWise investigations, and provide subject matter expertise during regulatory inspections. Your role is more than a job; it's an opportunity to mentor junior staff and embody Biogen's core values, fostering an environment of continuous improvement and cross-functional collaboration.

What You’ll Do:

• Perform microbiological testing on drug substance and utilities.
• Execute gram stains, sub-culturing of isolates, bacterial identification, and growth promotion testing.
• Coordinate and schedule testing in alignment with manufacturing timetables.
• Uphold equipment maintenance, ensuring organization, cleanliness, and accurate logbooks.
• Provide support to the Quality Control department in its daily functions.
• Draft, review, and update QC Standard Operating Procedures and change controls.
• Design and complete qualification protocols and reports for microbiological assays.
• Respond to and document Out of Limit and Out of Specification results, including laboratory investigations.
• Maintain data integrity in all work, adhering to Good Documentation Practices.
• Conduct GEMBA walk-throughs to ensure laboratory compliance.
• Train colleagues as needed and provide Microbiology expertise to cross-functional teams.
• Assist with change control, non-conformance, and CAPA initiatives.
• Participate in inspections and audits by health authorities and customers.
• Support the department manager in directing the team and resolving operational challenges.

Qualifications

Who You Are: You are a seasoned professional with a robust background in microbiological methodologies and a passion for working collaboratively. Your experience in cGMP-regulated environments has honed your understanding of risk management, sterility assurance, and microbial monitoring. You are someone who appreciates the importance of clean room practices, laboratory compliance, and you are comfortable with computerized systems that support a paperless lab environment. Your ability to work independently, coupled with your commitment to research and investigation, makes you an invaluable asset to any team. Reporting to the Senior Manager of QC Microbiology, you are ready to take on a role that is both challenging and rewarding.

Required Skills:

• Bachelor’s degree or equivalent with 8+ years of experience or Master's degree with 5+ years of experience in GMP biologics or pharmaceutical environment.
• Expertise with BacT assay, endotoxin testing, growth promotion, and bioburden testing.
• Familiarity with biotechnology and modern analytical microbiological techniques.
• Strong organizational and communication skills.
• Results-driven with a keen focus on quality and precision.
• Proven problem-solving abilities.
• Experience working autonomously and in cross-functional teams.
• Flexibility for occasional weekend work and on-call duties.

Preferred Skills:

• Advanced degree in Microbiology or related field.
• Leadership experience or demonstrated capability to mentor junior staff.
• Experience acting as an SME during regulatory inspections.

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.