Mfg Scientist II

About This Role

 

The Mfg Scientist II will provide key technical leadership for materials and analytics of clinical and commercial manufacturing campaigns at the Solothurn Drug Substance manufacturing facility. You will be part of the Global Manufacturing Sciences group.

You will lead raw material investigation, forensics and analytics in the Manufacturing Sciences Laboratory and establish or extend data system applications for material trending, analysis, genealogy. This position supports material related facility fits, process transfer activities and campaign readiness in cross functional teams for new production introduction, process validation & life-cyle management and regulatory commitments as required. The role extends into USP or DSP Process Transfer & Sciences team activities as per internal organization and internal workload. 

What You'll Do 

Lead raw material forensics capabilities at the Solothurn Manufacturing Sciences laboratory. Maintain and extend analytical equipment and methods, support general laboratory operations management & guide junior team members. 

Provide technical expertise to operations by leading resolution of raw material related investigations, performing impact assessments and leading the implementation of CAPAs & GCCs.

Lead material related facility fits, process transfer activities & campaign readiness activities as well as projects towards improved facility capabilities, process understanding, robustness and efficiency. Extends into USP & DSP as per internal organization / workload. 

Establish and extend data system applications for raw material data trending, analysis and genealogy.

Author and review technical protocols & reports. Provide SME support during regulatory audits and support meeting regulatory filing & RtQ commitments. Ensure timely, clear communication and escalation of results.

Who You Are 

You have experience from a similar role where you lead raw material investigation, forensics, and analytics at a Drug Substance facility. You role involves managing lab operations, supporting process transfers, and ensuring readiness for manufacturing campaigns. You have also developed data systems for material trending, to enhance process efficiency, and provide inclusive expertise during regulatory audits.

Qualifications

PhD, MSc or BSc in Biochemistry, Chemistry, Chemical or Bioprocess Engineering, Biology, or closely allied discipline. 

BS with at least 8 years experience 

MS with at least 4 years experience

PhD with at least 2 years experience 

Identify opportunities for process improvements and execute changes as necessary.

Deep understanding of process descriptions, control strategies, and process technology.

Proficient with operational quality concepts and quality management systems.

Knowledgeable in manufacturing execution systems (e.g., Syncade and Delta V) and extended biotechnology processes.

Identify and implement cGMP improvements.

Ensure compliance with cGMP and good documentation practices.

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. to learn more about our DE&I efforts.