Asahi Kasei Corporation
Associate Director of Process Development, AFD
Asahi Kasei Corporation, Fremont, California, us, 94537
Associate Director of Process Development, AFD page is loaded## Associate Director of Process Development, AFDremote type:
On-sitelocations:
Fremont, CAtime type:
Full timeposted on:
Posted Yesterdayjob requisition id:
R5204## The Asahi Kasei Group operates with a commitment of creating for tomorrow.
Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.**Company:**Bionova Scientific LLC**Job Description:****Company Summary:**Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products.
As part of our business expansion plan, we are building a state-of-the-art facility that specializes in the development and manufacturing of Plasmid DNA. This facility will be equipped with cutting-edge technology and staffed by a team of highly skilled professionals who are dedicated to advancing the field of Plasmid DNA process development and manufacturing.
Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client challenges.Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve.
Adaptability and an interest in transformative action are also common attributes among our team.**Position Summary:**The Associate Director of Analytical and Formulation Development will be responsible for managing analytical activities in support of drug substance and drug product development. This position requires experience with clinical-stage product development, and method development/validation/transfer.**Essential Duties and Responsibilities:*** Oversee and manage a team engaged in AFD and QC transfer activities. Act as an SME for Analytical Development in the support of drug substance and drug product development, including process chemistry and formulation development.* Provide technical review of analytical data integrity, method development, and method validation protocols/reports.* Represent functional CMC role and participate in cross functional project teams and manage multiple priorities in a fast-paced, dynamic environment and enact quick problem solving to ensure on-time supply of drug to support GLP toxicology studies and IND-enabling activities across a portfolio of programs.* Act as primary liaison for analytical testing performed by external contract organizations and review data collected.* Ensure that testing methodologies meet phase-appropriate cGMP requirements.* Work with internal subject matter experts to author and review analytical test methods, protocols, and development reports.* Review method transfer reports/qualification/validation plans and reports by clients.* Author analytical CMC modules to support regulatory filings.* Develop sensitive and robust analytical test methods to support release testing and characterization of drug products.* Lead and guide the junior analysts for daily analytical activities.**Working Conditions:*** This position requires working in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 20 pounds independently.**Qualifications:*** Ph.D. or Master’s degree in biochemistry, analytical chemistry, biology or related discipline with 8-10+ years’ experience, or BS for 15+ years’ experience in an analytical and/or QC laboratories.* In-depth hands-on experience and understanding of protein chemistry and industry-standard analytical tools (CE, HPLC/UPLC, Mass Spec, ELISA, qPCR assays, compendial assays, etc.) and troubleshooting.* in depth understanding of process development from early to late stage.* Demonstrated expertise with analytical method development, phase appropriate method qualification/validation, release and stability testing, product characterization and specification development and justification.* Exhibited track record of success in delivering timely execution of CMC activities ranging from non-GMP and IND-enabling material supplies, through GMP clinical trial supplies.* Demonstrated knowledge and application of current industry and compendial standards and regulatory authority guidance and expectations, including ICH, FDA, MHRA, and EMA guidelines and USP-NF, Ph. Eur, BP, and JP compendia.* Prior experience in early phase and late phase development (both drug substance and drug product).* Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines.* Exhibited strong organizational and critical thinking skills with an attention to detail enabling sound, technically driven decision making.* Proven strong interpersonal, organization and problem-solving skillsCompensation Range: The base compensation range for this role is between $150,000 and $170,000. However, the actual compensation may vary depending on your experience and qualifications.Health Benefits and Program: Bionova offers health benefits at a subsidized rate.Healthcare, Dental, and Vision insuranceLife Insurance and Disability Program: 100% covered by Bionova.Retirement Plan (401K) Up to 8% of Employer MatchPaid time off up to two weeks10 days of Holidays and 5 days of Sick Leave.*As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.*Asahi Kasei in North America emphasizes recruiting key talent within the region. Across our multiple business units, we focus on growth, innovation, and initiative to help develop our people and give them the resources they need to succeed. Part of our mission is to be a good corporate citizen, dedicating our time to employees, customers, and communities around us.As an employer, Asahi Kasei offers a comprehensive benefits package, growth opportunities throughout our companies, and a diverse environment to enhance your career.**About Asahi Kasei**The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age.With more than 46,000 employees around the world, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. In North America, Asahi Kasei currently has over 23 business units and 10,000 employees.**Our People**Asahi Kasei recognizes that our people are our greatest strength. We operate with an emphasis on developing our employees and promoting from within. Our broad spectrum of companies within #J-18808-Ljbffr
On-sitelocations:
Fremont, CAtime type:
Full timeposted on:
Posted Yesterdayjob requisition id:
R5204## The Asahi Kasei Group operates with a commitment of creating for tomorrow.
Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.**Company:**Bionova Scientific LLC**Job Description:****Company Summary:**Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products.
As part of our business expansion plan, we are building a state-of-the-art facility that specializes in the development and manufacturing of Plasmid DNA. This facility will be equipped with cutting-edge technology and staffed by a team of highly skilled professionals who are dedicated to advancing the field of Plasmid DNA process development and manufacturing.
Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client challenges.Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve.
Adaptability and an interest in transformative action are also common attributes among our team.**Position Summary:**The Associate Director of Analytical and Formulation Development will be responsible for managing analytical activities in support of drug substance and drug product development. This position requires experience with clinical-stage product development, and method development/validation/transfer.**Essential Duties and Responsibilities:*** Oversee and manage a team engaged in AFD and QC transfer activities. Act as an SME for Analytical Development in the support of drug substance and drug product development, including process chemistry and formulation development.* Provide technical review of analytical data integrity, method development, and method validation protocols/reports.* Represent functional CMC role and participate in cross functional project teams and manage multiple priorities in a fast-paced, dynamic environment and enact quick problem solving to ensure on-time supply of drug to support GLP toxicology studies and IND-enabling activities across a portfolio of programs.* Act as primary liaison for analytical testing performed by external contract organizations and review data collected.* Ensure that testing methodologies meet phase-appropriate cGMP requirements.* Work with internal subject matter experts to author and review analytical test methods, protocols, and development reports.* Review method transfer reports/qualification/validation plans and reports by clients.* Author analytical CMC modules to support regulatory filings.* Develop sensitive and robust analytical test methods to support release testing and characterization of drug products.* Lead and guide the junior analysts for daily analytical activities.**Working Conditions:*** This position requires working in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 20 pounds independently.**Qualifications:*** Ph.D. or Master’s degree in biochemistry, analytical chemistry, biology or related discipline with 8-10+ years’ experience, or BS for 15+ years’ experience in an analytical and/or QC laboratories.* In-depth hands-on experience and understanding of protein chemistry and industry-standard analytical tools (CE, HPLC/UPLC, Mass Spec, ELISA, qPCR assays, compendial assays, etc.) and troubleshooting.* in depth understanding of process development from early to late stage.* Demonstrated expertise with analytical method development, phase appropriate method qualification/validation, release and stability testing, product characterization and specification development and justification.* Exhibited track record of success in delivering timely execution of CMC activities ranging from non-GMP and IND-enabling material supplies, through GMP clinical trial supplies.* Demonstrated knowledge and application of current industry and compendial standards and regulatory authority guidance and expectations, including ICH, FDA, MHRA, and EMA guidelines and USP-NF, Ph. Eur, BP, and JP compendia.* Prior experience in early phase and late phase development (both drug substance and drug product).* Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines.* Exhibited strong organizational and critical thinking skills with an attention to detail enabling sound, technically driven decision making.* Proven strong interpersonal, organization and problem-solving skillsCompensation Range: The base compensation range for this role is between $150,000 and $170,000. However, the actual compensation may vary depending on your experience and qualifications.Health Benefits and Program: Bionova offers health benefits at a subsidized rate.Healthcare, Dental, and Vision insuranceLife Insurance and Disability Program: 100% covered by Bionova.Retirement Plan (401K) Up to 8% of Employer MatchPaid time off up to two weeks10 days of Holidays and 5 days of Sick Leave.*As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.*Asahi Kasei in North America emphasizes recruiting key talent within the region. Across our multiple business units, we focus on growth, innovation, and initiative to help develop our people and give them the resources they need to succeed. Part of our mission is to be a good corporate citizen, dedicating our time to employees, customers, and communities around us.As an employer, Asahi Kasei offers a comprehensive benefits package, growth opportunities throughout our companies, and a diverse environment to enhance your career.**About Asahi Kasei**The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age.With more than 46,000 employees around the world, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. In North America, Asahi Kasei currently has over 23 business units and 10,000 employees.**Our People**Asahi Kasei recognizes that our people are our greatest strength. We operate with an emphasis on developing our employees and promoting from within. Our broad spectrum of companies within #J-18808-Ljbffr