Immunome, Inc.
Director of Analytical Development and QC, Small Molecule
Immunome, Inc., Bothell, Washington, United States, 98021
Company Overview
Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs.) In addition to a portfolio of discovery-stage ADCs, our pipeline includes AL102, a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025.
Position Overview
We are looking for a Director of Analytical Development and Quality Control to support our Small Molecule Team, focusing primarily on ADC Linker Payloads as well as other pipeline projects. This leadership role will be responsible for overseeing all aspects of analytical development, with a focus on enhancing our internal capabilities while collaborating with Contract Development and Manufacturing Organizations (CDMOs). In addition, this role will be key in establishing QC capabilities for small molecule internally. The ideal candidate will have a robust background in small molecule development and QC, a proven track record in managing teams, and extensive experience in CDMO oversight and collaboration.
Responsibilities
Strategic Leadership
Develop and implement analytical development strategies to support the progression of small molecule linker payload projects from preclinical through clinical phases.
CDMO Collaboration
Oversee and manage relationships with external CDMOs, ensuring alignment with project timelines, quality standards, and regulatory requirements.
Internal Capability Development
Lead efforts to build and enhance internal analytical development capabilities, including method development, validation, and transfer processes.
Team Management
Recruit, mentor, and manage a team of analytical scientists and analysts, fostering a collaborative and innovative environment.
Regulatory Compliance
Ensure that all analytical methods and processes comply with relevant regulatory guidelines and industry best practices.
Data Analysis and Interpretation
Provide scientific guidance on data analysis and interpretation, contributing to the preparation of regulatory submissions and technical reports.
Cross-Functional Collaboration
Work closely with cross-functional teams, including discovery and process chemistry, formulation development, and quality assurance, to ensure alignment on project goals and objectives.
Budget Management
Oversee budget allocation for analytical development activities, ensuring cost-effective use of resources.
Qualifications
A Bachelor’s or Advanced degree in Analytical Chemistry, Chemistry, or a related field.
A minimum of 10 years of experience in analytical development method development, with significant experience in small molecule linker payloads.
Prior experience managing CDMO relationships, tech transfer, and Quality Control programs.
Knowledge and Skills
Proven experience managing CDMO relationships and overseeing outsourcing strategies.
Strong background in method development and phase-appropriate validation, with a thorough understanding of regulatory guidelines (FDA, EMA, etc.).
Deep and broad knowledge of analytical chemistry in support of small molecule release and stability method development, raw material control, in process control, and characterization.
Demonstrated leadership and team management skills, with the ability to motivate and develop scientific talent.
Comfort with ambiguity and uncertainty; adapts swiftly and leads others through complex situations.
Excellent communication and interpersonal skills, with a strong ability to collaborate across functions.
Strong analytical and problem-solving skills, with a keen attention to detail.
Position may require occasional evening and/or weekend commitment.
Position may require domestic and international travel.
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr
Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs.) In addition to a portfolio of discovery-stage ADCs, our pipeline includes AL102, a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025.
Position Overview
We are looking for a Director of Analytical Development and Quality Control to support our Small Molecule Team, focusing primarily on ADC Linker Payloads as well as other pipeline projects. This leadership role will be responsible for overseeing all aspects of analytical development, with a focus on enhancing our internal capabilities while collaborating with Contract Development and Manufacturing Organizations (CDMOs). In addition, this role will be key in establishing QC capabilities for small molecule internally. The ideal candidate will have a robust background in small molecule development and QC, a proven track record in managing teams, and extensive experience in CDMO oversight and collaboration.
Responsibilities
Strategic Leadership
Develop and implement analytical development strategies to support the progression of small molecule linker payload projects from preclinical through clinical phases.
CDMO Collaboration
Oversee and manage relationships with external CDMOs, ensuring alignment with project timelines, quality standards, and regulatory requirements.
Internal Capability Development
Lead efforts to build and enhance internal analytical development capabilities, including method development, validation, and transfer processes.
Team Management
Recruit, mentor, and manage a team of analytical scientists and analysts, fostering a collaborative and innovative environment.
Regulatory Compliance
Ensure that all analytical methods and processes comply with relevant regulatory guidelines and industry best practices.
Data Analysis and Interpretation
Provide scientific guidance on data analysis and interpretation, contributing to the preparation of regulatory submissions and technical reports.
Cross-Functional Collaboration
Work closely with cross-functional teams, including discovery and process chemistry, formulation development, and quality assurance, to ensure alignment on project goals and objectives.
Budget Management
Oversee budget allocation for analytical development activities, ensuring cost-effective use of resources.
Qualifications
A Bachelor’s or Advanced degree in Analytical Chemistry, Chemistry, or a related field.
A minimum of 10 years of experience in analytical development method development, with significant experience in small molecule linker payloads.
Prior experience managing CDMO relationships, tech transfer, and Quality Control programs.
Knowledge and Skills
Proven experience managing CDMO relationships and overseeing outsourcing strategies.
Strong background in method development and phase-appropriate validation, with a thorough understanding of regulatory guidelines (FDA, EMA, etc.).
Deep and broad knowledge of analytical chemistry in support of small molecule release and stability method development, raw material control, in process control, and characterization.
Demonstrated leadership and team management skills, with the ability to motivate and develop scientific talent.
Comfort with ambiguity and uncertainty; adapts swiftly and leads others through complex situations.
Excellent communication and interpersonal skills, with a strong ability to collaborate across functions.
Strong analytical and problem-solving skills, with a keen attention to detail.
Position may require occasional evening and/or weekend commitment.
Position may require domestic and international travel.
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr