Sr Associate I, Integrated Upstream Quality Operations

Sr Associate I, Integrated Upstream Quality Operations

• Full-time
• Region: EU+/Canada
• Department: Quality

Job Description

About This Role:

As a Senior Associate I within the Integrated Upstream Quality Operations team, you will play a pivotal role in the Quality Department of our cutting-edge Large-Scale Manufacturing facility in Solothurn, Switzerland. Your focus will be on Quality Operations and Quality Engineering, specifically concerning upstream processes, utilities, and dispensary and warehouse manufacturing and equipment. Your efforts will ensure that all products meet the highest standards of safety, efficacy, and purity. By reviewing and approving GMP documents and partnering with various teams, you contribute to the seamless operation of a site that boasts a fully integrated electronic batch record system. Your role is integral to the site's success, providing expertise that supports both day-to-day operations and strategic initiatives. You will be part of a team that values continuous improvement and quality excellence, situated within a company structure that prioritizes innovation and patient outcomes.

What You’ll Do:

• Oversee shopfloor manufacturing operations, including electronic Batch Record and eLogbook review.
• Handle minor and major deviations in adherence to Quality Management standards.
• Review and provide quality oversight for change controls, Maintenance and Calibrations records.
• Participate in Validation and cleaning protocol activities, ensuring compliance and quality.
• Drive continuous improvement projects, coach and mentor quality associates, and support tech transfer.
• Act as a Subject Matter Expert during internal and external audits.
• Engage in Quality On-Call duty rotation to maintain quality standards.
• Participate in batch review for Bulk Drug Substance (BDS) and facilitate batch record review and release.
• Initiate and implement Continuous Improvement Ideas for quality systems and processes.
• Collaborate with Manufacturing, Manufacturing Sciences, and Process Engineering teams on deviations and investigations.
• Ensure adherence to internal procedures for manufacturing operations and equipment controls.
• Provide expertise in GMP CAPEX and OPEX projects, including shutdowns and new product introductions.

Qualifications

Who You Are:

You are a dedicated professional with a passion for quality in the biotechnology field. You have a keen eye for detail and a commitment to ensuring the highest standards are met. You thrive in a collaborative environment, working alongside cross-functional teams to drive results. Your proactive approach and ability to operate autonomously, coupled with your strong organizational skills, make you a valuable asset to any team. You possess excellent communication skills, which you use effectively to share your knowledge and mentor others. Your problem-solving abilities are top-notch, enabling you to tackle complex challenges with confidence.

Required Skills:

• Bachelor’s degree in Chemical Engineering, Bioengineering, Biotechnology, Bioprocessing, Pharmaceutical Sciences, or Pharmaceutical Regulations with a minimum of 8 years of experience in a GMP pharmaceutical or biotech manufacturing environment (Master’s degree with at least 6 years of experience preferred).
• At least 3 years of experience in a Quality Assurance role.
• Demonstrated ability to work autonomously and with cross-functional team members.
• Strong presentation and organizational skills.
• Demonstrated writing and problem-solving skills.
• Proficiency in English at a B2 level minimum.

Preferred Skills:

• Experience with Quality Assurance and quality engineering in upstream processes.
• Demonstrated skills in collaboration and coaching.

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.