Director, Downstream Process Development

Director, Downstream Process Development

WuXi Biologics is a is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. WuXi Biologics’ achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD cultureof Passion, Reward, Opportunity, Unity and Determination.WuXiBiologics offers exciting job opportunitiesandcareers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies

Job Summary

We are seeking a dynamic and experienced professional to fill the role of Director or Sr. Director of Downstream Process Development. The successful candidate will lead our Downstream Process Development teams in designing, implementing, and optimizing Downstream Processes for the development of various biological molecules, including monoclonal antibodies (mAbs), biospecific & multispecific, novel protein modalities, mRNA, enzymes, and viral proteins. The position involves collaborating closely with internal teams, global sites, and external clients to ensure successful technology transfer and support manufacturing activities from early-phase through commercialization.

Requirements:

• Lead and manage a team responsible for Downstream Process Development, optimization, and technology transfer to cGMP manufacturing.
• Define and execute the strategic direction of the department. Identify, evaluate, and execute process improvements to enhance existing capabilities.
• Oversee the development of scalable processes for optimal expression, purification, and quality attributes of antibodies, recombinant proteins, and other biomolecules.
• Collaborate with Manufacturing Sciences and Technology (MSAT) group to ensure seamless transfer of processes from PD into manufacturing for early-phase through commercial manufacturing activities
• Provide scientific and business consultation to the site and executive leadership team.
• Balance stakeholders and interact closely with clients, Manufacturing and CMC teams to ensure timelines and expectations are met.

Qualifications:

• Ph.D. in biological sciences, biochemistry, chemical engineering, or related field with a minimum of 8 years of relevant experience. Alternatively, a Bachelor's degree with 15+ years of relevant experience or a Master's degree with 12+ years of relevant experience will be considered.
• Significant experience in leading and managing a team of bioProcess Development scientists or engineers, demonstrating direct involvement in developing programs from early stages through licensure.
• Expertise and strong technical knowledge in Downstream Process Development, scale-up, technology transfer, and manufacturing, with a specific focus on chromatography and membrane filtration for biomolecules such as mAbs and recombinant proteins.
• Proven experience in process characterization using Design of Experiments (DOEs) and Quality by Design (QbD) concepts.
• Demonstrated ability to proactively identify and implement novel technologies.
• Proven track record of scientific publications and conference presentations.
• Strong collaboration and leadership skills to drive continuous improvement and promote knowledge sharing and implementation of best practices.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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