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

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