Senior Process Engineer DSP

As a Senior Process Specialist, you will be responsible for leading and optimizing the manufacturing processes for the production of antibodies within the organization. They will play a crucial role in ensuring the efficient and high-quality manufacturing of antibodies, adhering to industry standards and regulatory requirements. Senior Process Specialists´ expertise will contribute to the success of antibody manufacturing operations and the delivery of effective therapeutic products.

Duties and Responsibilities

• Act as first-line and direct contact with clients from MFG to understand their requirements and incorporate them into the manufacturing processes.
• Act as a bridge between cross-functional teams, including PD, MSAT, Quality and RA, and MFG to ensure seamless technology transfer and process scalability.
• Provide documentation support for project-specific documents, including PFD, BOM, validation protocols and SOPs, etc.
• Create and maintain MBRs, ensuring compliance with regulatory guidelines.
• Creation of recipes and design of single-use assemblies for each process.
• Contribute to gap/risk assessments and mitigation, to ensure our products and processes are compliant with internal and external requirements and expectations
• Identify opportunities for continuous improvement in manufacturing operations. Lead or participate in cross-functional teams to implement process enhancements, such as implementing automation, lean manufacturing principles, or new technologies to enhance productivity, reduce costs and minimize human error.
• Identify and resolve process-related issues, deviations, and non-conformances in a timely manner. Investigate root causes, propose corrective actions, and implement preventive measures to minimize process disruptions and maintain product quality.
• Serves as Subject Matter Expert for process and equipment during internal and external regulatory audits (including FDA, EMEA, etc.).
• Train Process Specialists, providing guidance and support to ensure their professional growth.
• Working Relations (describing reporting line and functions to work with)
• Senior Process Specialist report to Process Specialist DSP Team Shift Lead and work with Manufacturing Excellence Function.

Person Specification

Qualifications and Experience

• Bachelor's degree in Biotechnology, Biochemistry, or a related field. A master's degree or Ph.D. is preferred.
• 7+ years of relevant work experience for candidates with Bachelor´s degrees, 4+ years of relevant work experience for candidates with Master´s degrees or 2+ years of relevant work experience for candidates with Ph.D degrees within a pharmaceutical manufacturing environment, with a focus on upstream cell culture and downstream purification processes.
• Experience with technology transfer and scale-up of manufacturing processes.
• Excellent problem-solving and analytical skills, with the ability to identify and resolve complex manufacturing issues.
• A good understanding of cGMP is preferred.
• Good understanding of regulatory and industry standards/guidelines.
• Strong ethical foundation and a sound compliance understanding.
• Strong interpersonal communication skills and team player mindset.
• Fluent in English, German is preferred.

WuXi Biologics is an equal opportunities employer