Immunome, Inc.
Associate Director/Director, Chemical Development
Immunome, Inc., Bothell, Washington, United States, 98021
Description:Job title:
Associate Director/Director of Chemical Development
Location:
Bothell
About Us :
Immunome is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including immunotherapies, targeted effectors, radioligand therapies and antibody drug conjugates (ADCs). We believe that pursuing underexplored targets with appropriate drug modalities leads to transformative therapies. Our proprietary memory B cell hybridoma technology allows for the rapid screening and functional characterization of novel antibodies and targets.
Position summary :
We are seeking an experienced process development chemist) to join our dynamic team in advancing our pipeline of innovative targeted cancer therapies. The successful candidate will bring expertise in small molecule and/or drug linker process development and manufacturing. The successful candidate will apply their expertise in small molecule process development and manufacturing towards a variety of modalities in the Immunome pipeline including antibody drug conjugates, radiopharmaceuticals. This person will play a key role in leading challenging drug candidate process development programs thus enabling treatment of patients in need.
Key Responsibilities :
Leadership :
Provide leadership as a key member of the chemical development team while maintaining alignment with the company's goals and objectives.
Lead and execute one or more projects as part of a broader team towards the successful advancement of antibody drug conjugates, radiopharmaceuticals, and other lead programs.
Technical expertise :
Extensive knowledge and experience in the development and execution of small molecule synthetic processes which are robust and scalable.
Specifically, execute on the development and manufacturing strategies for the production of complex small molecule targets for antibody drug conjugates, targeted effectors and radiopharmaceuticals in early and late-stage development.
Assist in the preparation of regulatory documents, including Investigational New Drug (IND) applications, New Drug Applications (NDAs/MAAs).
Ensure compliance with regulatory requirements, with a focus on CMC aspects related to pharmaceutical quality.
Program Leadership :
Represent chemical development on program teams and work with cross-functional stakeholders from early stages through clinical development and commercialization.
Create development plans and oversee development and manufacturing at our contract partners.
Provide business updates to senior leadership.
Cross-functional Collaboration :
Execute the integrated CMC regulatory strategies for pipeline programs.
Collaborate with research, regulatory affairs, and CMC teams to ensure seamless coordination of activities. Foster strong collaborations with internal and external stakeholders.
Innovation :
Stay abreast of the latest advancements in drug development science, proactively identify new technologies and methodologies to enhance our capabilities. Advances Immunome’s intellectual property portfolio.
Quality and Compliance :
Ensure compliance with relevant regulatory guidelines and industry standards for chemical development processes. Uphold high-quality standards and address any compliance issues.
Requirements:Educational Background :
Ph.D. in Synthetic Organic Chemistry, Chemical Engineering, or related field.
Professional Experience :
Minimum of 8 years of industry experience leading small molecule, antibody drug conjugates, or radiopharmaceuticals programs with at least 2 years in a technical leadership position.
Additional Leadership and technical skills include the following:
Ability to design cost effective robust manufacturing processes for complex small molecule targets as well as troubleshoot and solve complex technical challenges quickly.
Experience in managing chemical development teams, with a focus on complex small molecules, antibody drug conjugates and radiopharmaceuticals.
Experience in leading and managing technology transfers to third party process development and manufacturing partners.
Extensive knowledge of cGMP requirements and ICH guidelines related CMC small molecule drug-substance development and manufacturing.
Experience with drug development from pre-clinical through clinical development as well as late-stage development activities (including pre-validation and validation studies).
Track record of working closely with cross-functional teams in a biopharmaceutical or pharmaceutical environment.
In-depth knowledge of regulatory requirements related to chemical development and CMC.
Excellent judgment and agility with ability to lead or provide “hands-on” support.
Comfort with ambiguity and uncertainty; adapts swiftly and leads through complex situations.
Excellent interpersonal and communication skills.
Track record of innovation in the development of therapeutics.
Ability to solve complex scientific problems and make data-driven decisions.
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Salary band
$184,000 - $236,000
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Associate Director/Director of Chemical Development
Location:
Bothell
About Us :
Immunome is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including immunotherapies, targeted effectors, radioligand therapies and antibody drug conjugates (ADCs). We believe that pursuing underexplored targets with appropriate drug modalities leads to transformative therapies. Our proprietary memory B cell hybridoma technology allows for the rapid screening and functional characterization of novel antibodies and targets.
Position summary :
We are seeking an experienced process development chemist) to join our dynamic team in advancing our pipeline of innovative targeted cancer therapies. The successful candidate will bring expertise in small molecule and/or drug linker process development and manufacturing. The successful candidate will apply their expertise in small molecule process development and manufacturing towards a variety of modalities in the Immunome pipeline including antibody drug conjugates, radiopharmaceuticals. This person will play a key role in leading challenging drug candidate process development programs thus enabling treatment of patients in need.
Key Responsibilities :
Leadership :
Provide leadership as a key member of the chemical development team while maintaining alignment with the company's goals and objectives.
Lead and execute one or more projects as part of a broader team towards the successful advancement of antibody drug conjugates, radiopharmaceuticals, and other lead programs.
Technical expertise :
Extensive knowledge and experience in the development and execution of small molecule synthetic processes which are robust and scalable.
Specifically, execute on the development and manufacturing strategies for the production of complex small molecule targets for antibody drug conjugates, targeted effectors and radiopharmaceuticals in early and late-stage development.
Assist in the preparation of regulatory documents, including Investigational New Drug (IND) applications, New Drug Applications (NDAs/MAAs).
Ensure compliance with regulatory requirements, with a focus on CMC aspects related to pharmaceutical quality.
Program Leadership :
Represent chemical development on program teams and work with cross-functional stakeholders from early stages through clinical development and commercialization.
Create development plans and oversee development and manufacturing at our contract partners.
Provide business updates to senior leadership.
Cross-functional Collaboration :
Execute the integrated CMC regulatory strategies for pipeline programs.
Collaborate with research, regulatory affairs, and CMC teams to ensure seamless coordination of activities. Foster strong collaborations with internal and external stakeholders.
Innovation :
Stay abreast of the latest advancements in drug development science, proactively identify new technologies and methodologies to enhance our capabilities. Advances Immunome’s intellectual property portfolio.
Quality and Compliance :
Ensure compliance with relevant regulatory guidelines and industry standards for chemical development processes. Uphold high-quality standards and address any compliance issues.
Requirements:Educational Background :
Ph.D. in Synthetic Organic Chemistry, Chemical Engineering, or related field.
Professional Experience :
Minimum of 8 years of industry experience leading small molecule, antibody drug conjugates, or radiopharmaceuticals programs with at least 2 years in a technical leadership position.
Additional Leadership and technical skills include the following:
Ability to design cost effective robust manufacturing processes for complex small molecule targets as well as troubleshoot and solve complex technical challenges quickly.
Experience in managing chemical development teams, with a focus on complex small molecules, antibody drug conjugates and radiopharmaceuticals.
Experience in leading and managing technology transfers to third party process development and manufacturing partners.
Extensive knowledge of cGMP requirements and ICH guidelines related CMC small molecule drug-substance development and manufacturing.
Experience with drug development from pre-clinical through clinical development as well as late-stage development activities (including pre-validation and validation studies).
Track record of working closely with cross-functional teams in a biopharmaceutical or pharmaceutical environment.
In-depth knowledge of regulatory requirements related to chemical development and CMC.
Excellent judgment and agility with ability to lead or provide “hands-on” support.
Comfort with ambiguity and uncertainty; adapts swiftly and leads through complex situations.
Excellent interpersonal and communication skills.
Track record of innovation in the development of therapeutics.
Ability to solve complex scientific problems and make data-driven decisions.
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Salary band
$184,000 - $236,000
#J-18808-Ljbffr