Associate Director Downstream Process Development - Wuxi Biologics : Job Details

Associate Director Downstream Process Development

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Associate Director Downstream Process Development

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Job Title: Associate Director, Downstream Process DevelopmentJob Location: Cranbury, NJWuXi 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.Job Summary:Lead and manage a team responsible for downstream process development, optimization, process scale-up to non-GMP scales, 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. Balance stakeholders and interact closely with clients, Manufacturing and CMC teams to ensure timelines and expectations are met. Provide scientific and business consultation to the site and executive leadership team.Responsibilities:

• 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. Designs, executes, and authors downstream purification development, optimization, scale up and tech transfer.
• Responsible for bench scale purification process development, optimization, and process transfer studies.
• Designs and executes pilot-scale experiments to support non-GMP material generation.
• Manages project workflow to ensure on timely delivery: from initial planning, experiment execution, to data evaluation.
• Supervises or performs independent data analysis, interpretation, and develops strategies for optimization and troubleshooting.
• Authors study protocols and reports, and ensures all data are reported clearly and accurately; Serves as trainer for inter- and intra-departmental staff as needed.
• Leads tech transfer to GMP manufacturing and supports deviations and investigations.
• Serves as Downstream purification SMEs to participates in client calls and face to face meetings. Provides project plans and updates to clients.
• Coach junior and senior scientists and staff on process development and design of experiments.
• Authors Downstream lab equipment SOPs; maintains equipment functionality and coordinates repairs and preventative maintenance.
• Performs job specific tasks in compliance with applicable Regulations, International Standards, and WuXi Biologics internal policies and guidelines.
• Completes all required training (i.e. safety, equipment etc.).
• Contributes to the overall operations and to the achievement of departmental goals.
• May be required to assist in other departments or assigned other duties.

Qualifications:

• Ph.D. in Life Sciences or related field with 8+ years, or Master Degree with 12+ years of experience in a biopharmaceutical or biological contract testing/manufacturing organization.
• Expertise, strong technical knowledge and hands-on experience in downstream purification process development and lab scale and pilot scale experimental execution, including chromatography, UFDF, viral inactivation, depth filtration, and viral filtration, etc., for biomolecules such as mAbs and recombinant proteins.
• Experience with early-stage and late-stage CMC of different biologics modalities.
• Experience in project management, Quality by Design concepts, late-stage process development/tech transfer, control strategy is highly desirable.
• 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.
• 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.
• Experience in a cGMP environment is highly desirable.
• Ability to take on multiple tasks simultaneously is required.
• Proficient in Microsoft (Excel, Word, Outlook)

Physical Requirements:

• Must be able to work in Lab setting with Biohazards/various Chemicals
• Must be able to wear appropriate PPEs
• Ability to Lift 40 lbs

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 disabilityThe anticipated pay range for this position is $112,000-$190,000

Seniority level

• Seniority levelDirector

Employment type

• Employment typeContract

Job function

• Job functionResearch, Analyst, and Information Technology
• IndustriesPharmaceutical Manufacturing

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