WuXi Biologics
Associate Director Downstream Process Development
WuXi Biologics, Cranbury, New Jersey, United States
Associate Director Downstream Process Development
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Associate Director Downstream Process Development
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WuXi Biologics Associate Director Downstream Process Development
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Associate Director Downstream Process Development
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WuXi Biologics Get AI-powered advice on this job and more exclusive features. Job Title: Associate Director, Downstream Process Development
Job Location: Cranbury, NJ
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.
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 disability
The anticipated pay range for this position is $112,000-$190,000 Seniority level
Seniority level Director Employment type
Employment type Contract Job function
Job function Research, Analyst, and Information Technology Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at WuXi Biologics by 2x Sign in to set job alerts for “Director Process Development” roles.
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Join to apply for the
Associate Director Downstream Process Development
role at
WuXi Biologics Associate Director Downstream Process Development
18 hours ago Be among the first 25 applicants Join to apply for the
Associate Director Downstream Process Development
role at
WuXi Biologics Get AI-powered advice on this job and more exclusive features. Job Title: Associate Director, Downstream Process Development
Job Location: Cranbury, NJ
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.
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 disability
The anticipated pay range for this position is $112,000-$190,000 Seniority level
Seniority level Director Employment type
Employment type Contract Job function
Job function Research, Analyst, and Information Technology Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at WuXi Biologics by 2x Sign in to set job alerts for “Director Process Development” roles.
New Jersey, United States $130,000.00-$170,000.00 2 weeks ago New Jersey, United States $190,000.00-$215,000.00 2 weeks ago Woodbridge, NJ $127,500.00-$172,500.00 1 week ago Princeton, NJ $221,000.00-$277,000.00 1 week ago Hunterdon County, NJ $170,000.00-$200,000.00 6 days ago Edison, NJ $115,000.00-$135,000.00 1 week ago Somerset, NJ $163,468.00-$214,551.00 1 week ago Director, Biologics Process Development (BPD)
Rahway, NJ $169,700.00-$267,200.00 2 weeks ago Senior Director, Manufacturing Science and Technology
Hopewell, NJ $203,800.00-$273,800.00 5 days ago Titusville, NJ $193,000.00-$333,500.00 1 day ago Operational Excellence Deployment Director/Associate Director - Princeton, NJ
Princeton, NJ $176,300.00-$210,000.00 2 weeks ago Director, Analytical Research & Development
Princeton, NJ $150,000.00-$170,000.00 2 days ago Director, Congress Innovation, Operations and Capabilities
Princeton, NJ $207,490.00-$251,400.00 8 hours ago Operations Director OB/GYN/MFM - FT - Day - Capital Health Medical Group
Branchburg, NJ $134,250.00-$196,900.00 4 days ago New Jersey, United States $87,500.00-$87,500.00 1 day ago Executive Director, Biologics Analytical Research & Development
Rahway, NJ $250,800.00-$394,800.00 1 week ago Rahway, NJ $169,700.00-$267,200.00 5 days ago Director, Regulatory Affairs - Job ID: DRA
Princeton, NJ $225,000.00-$240,000.00 2 days ago Director, Managed Care Rebate Operations (MCRO)
Piscataway, NJ $100,000.00-$150,000.00 1 week ago Clark, NJ $145,000.00-$165,000.00 3 weeks ago Director, Utility Operations & Engineering
Newtown, PA $73,695.00-$96,928.00 1 week ago Westfield, NJ $145,000.00-$175,000.00 1 month ago Director, Medical Information and Operations, US (f/m/d)
Executive Director of R&D Global Quality (Princeton/Rockville) Hybrid
Burlington, NJ $135,000.00-$175,000.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr