Sparxbio
Director of Upstream Bioprocess
Sparxbio, Chicago, Illinois, United States,
We are seeking a highly motivated and enthusiastic lead in upstream process development located in Mount Prospect, IL. The successful candidate will be supervising a team that develops and implements mammalian cell culture processes for the production of biological therapeutic proteins. You and your team will be responsible for the scale-up, process development, and GMP production of monoclonal and multi-specific antibody drug candidates. The candidate will lead multiple projects and is expected to provide significant scientific and technical contributions within the organization, and will work closely with other departments to develop strong working relationships.Principal Duties and Responsibilities:
Drive the development of new cell culture and fermentation processes at laboratory scale and scale up to manufacturing scale.Plan, generate and execute protocols for DoE studies that include appropriate statistical analysis and generate reports.Assemble, operate, and troubleshoot single-use stirred tank bioreactors from bench scale to 500L working volume scale.Plan and execute various centrifuge, depth filtration, or other cell/virus culture harvest protocols.Support GMP manufacturing through tech transfer, training, and master batch record generation and review.Generate scientific reports, including process development reports, manufacturing summary reports, and supportive reports for IND CMC sections.Cross-train in downstream production, analytical development and other groups within the organization to gain knowledge and functional capability in these areas.Develop robust, scalable, and high productivity cell culture process for large scale production.Act as a resource for upstream process development.Required Qualifications:
A Ph.D. degree in Chemical/Biochemical Engineering, or Cell Biology, Biotechnology, Biochemistry, or related disciplines with 5 years of industry experience or an MS degree in these areas with 10 years of industry experience.Strong hands-on experience in mammalian cell culture in bioprocessing settings to produce active therapeutic proteins.Good problem-solving skills. Capable of finding the root cause of problems and solve them effectively.Collaborative and proactive attitude.Experience in cGMP, CMC activities is a plus.Ability to work within ISO 5/6/7/8 clean room environments.Desired Qualifications:
Display strong technical knowledge and scientific understanding of cell and virus culture, expansion, harvest, medium development, clone selection and development, and DoE studies, as well as experience in process development with both small and large process scales for antibody development.Hands on experience on developing, optimizing, and scaling-up mammalian cell and virus/viral vector-based processes, including cell banking, adherent and suspension cell cultures in batch, fed-batch, and perfusion modes.Demonstrated broad knowledge base in routine cell culture and sterile technique.Hands on experience with Cytiva’s XDR or Sartorius’ STR bioreactors, media and feed studies, harvest and clarification studies, and Ambr system.Excellent interpersonal and communication skills.Writing and reviewing technical documents with a basic understanding of regulatory requirements.Work with cross-functional teams on the implementation of process improvement initiatives to increase quality and productivity levels.Demonstrate an ability to multi-task and manage multiple projects independently. Maintain a safe work environment for self and staff.About SparX Group
SparX Biopharmaceutical Corp. is a research-based development-stage biopharmaceutical company, dedicated to the mission of “strengthening human immunity using robust antibody therapies” through the discovery and development of innovative immuno-oncology agents. Equipped with big data analytical techniques, such as machine learning algorithms, SparX extracts potential interactions from large volumes of complex multi-dimensional public information. Mechanistic pharmacological analyses coupled with in vitro and in vivo evaluations using the syngeneic, transgenic and humanized mouse models, enables SparX’s focus on developing novel or best-in-class therapeutics demonstrating substantial advantages over existing therapies.Target discovery and validation has historically been the bottleneck in drug development. SparX combines its sophisticated target discovery platform with an integrated multi-component SAILING™ antibody optimization system and a cutting-edge bi-ADC technology to markedly improve the success rate of empowered antibody drug development. In addition to the integrated antibody discovery platform, SparX has built in-house cGMP facilities of significant capacity to produce clinical and commercial drug products, facilitating its evolution into an integrated and independent biopharmaceutical company.EEOC Statement:
SparX is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. SparX is committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, marital status, sexual orientation, genetic information, uniform service member or veteran status, or any other characteristic protected by federal, state or local law. Further, SparX complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. SparX is an e-verify employer.
#J-18808-Ljbffr
Drive the development of new cell culture and fermentation processes at laboratory scale and scale up to manufacturing scale.Plan, generate and execute protocols for DoE studies that include appropriate statistical analysis and generate reports.Assemble, operate, and troubleshoot single-use stirred tank bioreactors from bench scale to 500L working volume scale.Plan and execute various centrifuge, depth filtration, or other cell/virus culture harvest protocols.Support GMP manufacturing through tech transfer, training, and master batch record generation and review.Generate scientific reports, including process development reports, manufacturing summary reports, and supportive reports for IND CMC sections.Cross-train in downstream production, analytical development and other groups within the organization to gain knowledge and functional capability in these areas.Develop robust, scalable, and high productivity cell culture process for large scale production.Act as a resource for upstream process development.Required Qualifications:
A Ph.D. degree in Chemical/Biochemical Engineering, or Cell Biology, Biotechnology, Biochemistry, or related disciplines with 5 years of industry experience or an MS degree in these areas with 10 years of industry experience.Strong hands-on experience in mammalian cell culture in bioprocessing settings to produce active therapeutic proteins.Good problem-solving skills. Capable of finding the root cause of problems and solve them effectively.Collaborative and proactive attitude.Experience in cGMP, CMC activities is a plus.Ability to work within ISO 5/6/7/8 clean room environments.Desired Qualifications:
Display strong technical knowledge and scientific understanding of cell and virus culture, expansion, harvest, medium development, clone selection and development, and DoE studies, as well as experience in process development with both small and large process scales for antibody development.Hands on experience on developing, optimizing, and scaling-up mammalian cell and virus/viral vector-based processes, including cell banking, adherent and suspension cell cultures in batch, fed-batch, and perfusion modes.Demonstrated broad knowledge base in routine cell culture and sterile technique.Hands on experience with Cytiva’s XDR or Sartorius’ STR bioreactors, media and feed studies, harvest and clarification studies, and Ambr system.Excellent interpersonal and communication skills.Writing and reviewing technical documents with a basic understanding of regulatory requirements.Work with cross-functional teams on the implementation of process improvement initiatives to increase quality and productivity levels.Demonstrate an ability to multi-task and manage multiple projects independently. Maintain a safe work environment for self and staff.About SparX Group
SparX Biopharmaceutical Corp. is a research-based development-stage biopharmaceutical company, dedicated to the mission of “strengthening human immunity using robust antibody therapies” through the discovery and development of innovative immuno-oncology agents. Equipped with big data analytical techniques, such as machine learning algorithms, SparX extracts potential interactions from large volumes of complex multi-dimensional public information. Mechanistic pharmacological analyses coupled with in vitro and in vivo evaluations using the syngeneic, transgenic and humanized mouse models, enables SparX’s focus on developing novel or best-in-class therapeutics demonstrating substantial advantages over existing therapies.Target discovery and validation has historically been the bottleneck in drug development. SparX combines its sophisticated target discovery platform with an integrated multi-component SAILING™ antibody optimization system and a cutting-edge bi-ADC technology to markedly improve the success rate of empowered antibody drug development. In addition to the integrated antibody discovery platform, SparX has built in-house cGMP facilities of significant capacity to produce clinical and commercial drug products, facilitating its evolution into an integrated and independent biopharmaceutical company.EEOC Statement:
SparX is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. SparX is committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, marital status, sexual orientation, genetic information, uniform service member or veteran status, or any other characteristic protected by federal, state or local law. Further, SparX complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. SparX is an e-verify employer.
#J-18808-Ljbffr