Mfg Scientist II, Downstream Process Transfer

About This Role 

As a Mfg Scientist II, Downstream Process Transfer, you will be an integral member of our Manufacturing Sciences team, focusing specifically on downstream process transfer. In this pivotal role, you will bring your expertise in DSP MS/MSAT to drive and support technology transfers, process development, and process validation activities at our state-of-the-art Solothurn Drug Substance manufacturing facility. You will manage critical downstream processes, lead complex investigations, and pioneer enhancements to existing procedures. Your contributions will play a significant role in ensuring our products meet the high standards required to improve patient outcomes. Through your collaborative efforts, you will help shape the operational excellence and strategic direction of our downstream processing capabilities, directly impacting the quality and efficiency of our biopharmaceutical production.

What You'll Do 

• Lead and coordinate cross-functional process transfer sub-teams for product introduction, PPQ, or campaign restarts.
• Serve as a technical leader for operations by guiding complex process-related investigations, impact assessments, CAPAs, and GCCs.
• Design and execute lab studies to support facility fit, campaigns, and innovation within the process science domain.
• Analyze data meticulously to enhance process consistency, robustness, and overall improvements.
• Author and review technical documents such as protocols, reports, and regulatory submissions related to process validation and investigations.
• Translate intricate process knowledge to guide and influence cross-functional stakeholders.
• Implement process improvements and partake in continuous learning to stay abreast of industry trends and best practices.
• Uphold stringent cGMP requirements and integrate them seamlessly into all aspects of your work.
• Contribute to the training and development of peers, fostering a culture of knowledge-sharing and collective growth.

Who You Are 

You are a subject matter authority in downstream drug substance manufacturing operations with a rich background in process sciences. Your robust experience in DSP MS/MSAT, process development, technology transfer, and process validation distinguishes you as a technical expert. You possess the unique ability to lead cross-functional teams, aligning technical expertise with strategic objectives. Your strong initiative and dedication to excellence influence those around you, making you a valuable team player. You are driven by the opportunity to make meaningful contributions that extend beyond the workplace, ultimately affecting the lives of patients who depend on our products.

Required Skills

• PhD, MSc, or BSc in Biochemistry, Chemistry, Chemical or Bioprocess Engineering, Biology, or a closely related discipline. (BS with at least 8 years of experience, MS with at least 4 years of experience, or PhD with at least 2 years of experience).
• Profound understanding of downstream process descriptions and control strategies.
• Expertise in process technology processes, especially DSP MS/MSAT.
• Comprehensive knowledge of operational quality concepts and proficiency in quality management systems.
• Familiarity with manufacturing execution systems (such as Syncade and Delta V).
• A clear grasp of cGMP requirements and their application in diverse settings.
• Exceptional investigational and technical writing skills.
• Effective communication skills, with a minimum English level of B1.
• Ability to provide guidance, training, and support to colleagues while promoting team objectives

Preferred Skills

• Proven track record of successful process improvement initiatives and complex investigation resolutions.
• Solid experience in bioprocess development within a GMP environment.
• Demonstrated ability in technical transfer and process validation projects.