Edgewise Therapeutics
Associate Director, Analytical Chemistry
Edgewise Therapeutics, Boulder, Colorado, United States, 80301
Associate Director, Analytical Chemistry
About Edgewise Therapeutics:
At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders.
We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!
About the position:
Edgewise Therapeutics is dedicated to advancing small molecule drug development programs focused in rare muscle disorders and cardiac disorders. This position is responsible for providing oversight for analytical development activities associated with drug substance and drug product to support preclinical studies, clinical development, and registration. The incumbent will be responsible for ensuring oversight of all the analytical development activities and testing performed by Contract Development and Manufacturing Organizations (CDMOs), including starting materials, in-process, release, and stability testing for clinical development and pre-commercial.
Key Responsibilities:
Responsible for the development, validation, and transfers of all analytical methods from pre-clinical through clinical development.
Participate in selection of contract manufacturing organizations and contract laboratories and oversee development and validation of methods for reference standards, starting materials, intermediates, release, and stability testing of both drug substance and drug product.
Author and provide technical review of relevant Chemistry, Manufacturing and Controls (CMC) analytical sections of INDs, IMPDs, and NDAs in regulatory dossiers, and ensure compliance with current regulatory requirements.
Design and execute phase-appropriate analytical strategies at CDMOs including analytical method development, qualification and validation for drug substance and drug product.
Develop and set specifications for raw materials, intermediates, drug substance, excipients and drug product.
Design and manage stability programs for non-GMP and cGMP drug substance and drug product batches and provide guidance for shelf-life and expiry dating.
Provide detailed and timely review for all relevant analytical data packages.
Establish workflows and procedures for analytical and quality control activities.
Develop strategies for reference standards program, coordinate sourcing, ensure inventory, plan and execute testing and retesting activities, and manage shipments of reference standards across CDMO network.
Manage and review deviation events and OOS/OOT investigations at CDMOs in coordination with CMC counterparts, QA and regulatory team members, as appropriate.
Author, review and approve various analytical reports in a timely manner to support drug substance and drug product development and manufacture, and regulatory filings.
Represent analytical function in CMC teams and project meetings and work closely with cross-functional teams to meet project timelines and goals.
Keep abreast of latest progress in analytical development, cGMP requirements and regulatory guidance.
Qualifications:
PhD in analytical chemistry or related discipline with more than 8 years of industry experience or BS/MS degree with more than 12 years industry experience.
Experience with analytical development of small molecules and solid oral dosage forms from preclinical to late-stage clinical development.
Experience managing analytical CMC development of drug substance and drug products in CDMOs from pre-clinical through registration and approval.
Expert level knowledge of analytical method development, method qualification/validation and method transfer.
Experience interpreting ICH and FDA guidance for analytical method qualification/validation, stability testing.
Extensive knowledge of GLP and cGMP requirements, appropriate regulatory guidance and current industry practices for analytical development.
Experience authoring analytical modules for regulatory submissions in all phases of development.
Hands-on experience with LCMS identification and qualification of impurities and degradation products is preferred.
Experience with setting specifications for drug substances and drug products and qualifying reference standards.
Demonstrated scientific excellence, technical leadership, and creativity.
Proven project management skills and productive collaboration with cross-functional teams.
Ability to deliver under tight timelines and adapt to changing project needs. Detailed and timely data review is a key element of this position.
Ability to work on multiple projects at the same time.
Ability to communicate, organize, and write well.
Salary range:
$165,000 - $195,000, title and salary commensurate with experience
Our Benefits:
We are proud to offer health benefits, a discretionary bonus plan, stock option grants, a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.
Application Process:
There is no deadline because the employer accepts applications on an ongoing basis. Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.
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About Edgewise Therapeutics:
At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders.
We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!
About the position:
Edgewise Therapeutics is dedicated to advancing small molecule drug development programs focused in rare muscle disorders and cardiac disorders. This position is responsible for providing oversight for analytical development activities associated with drug substance and drug product to support preclinical studies, clinical development, and registration. The incumbent will be responsible for ensuring oversight of all the analytical development activities and testing performed by Contract Development and Manufacturing Organizations (CDMOs), including starting materials, in-process, release, and stability testing for clinical development and pre-commercial.
Key Responsibilities:
Responsible for the development, validation, and transfers of all analytical methods from pre-clinical through clinical development.
Participate in selection of contract manufacturing organizations and contract laboratories and oversee development and validation of methods for reference standards, starting materials, intermediates, release, and stability testing of both drug substance and drug product.
Author and provide technical review of relevant Chemistry, Manufacturing and Controls (CMC) analytical sections of INDs, IMPDs, and NDAs in regulatory dossiers, and ensure compliance with current regulatory requirements.
Design and execute phase-appropriate analytical strategies at CDMOs including analytical method development, qualification and validation for drug substance and drug product.
Develop and set specifications for raw materials, intermediates, drug substance, excipients and drug product.
Design and manage stability programs for non-GMP and cGMP drug substance and drug product batches and provide guidance for shelf-life and expiry dating.
Provide detailed and timely review for all relevant analytical data packages.
Establish workflows and procedures for analytical and quality control activities.
Develop strategies for reference standards program, coordinate sourcing, ensure inventory, plan and execute testing and retesting activities, and manage shipments of reference standards across CDMO network.
Manage and review deviation events and OOS/OOT investigations at CDMOs in coordination with CMC counterparts, QA and regulatory team members, as appropriate.
Author, review and approve various analytical reports in a timely manner to support drug substance and drug product development and manufacture, and regulatory filings.
Represent analytical function in CMC teams and project meetings and work closely with cross-functional teams to meet project timelines and goals.
Keep abreast of latest progress in analytical development, cGMP requirements and regulatory guidance.
Qualifications:
PhD in analytical chemistry or related discipline with more than 8 years of industry experience or BS/MS degree with more than 12 years industry experience.
Experience with analytical development of small molecules and solid oral dosage forms from preclinical to late-stage clinical development.
Experience managing analytical CMC development of drug substance and drug products in CDMOs from pre-clinical through registration and approval.
Expert level knowledge of analytical method development, method qualification/validation and method transfer.
Experience interpreting ICH and FDA guidance for analytical method qualification/validation, stability testing.
Extensive knowledge of GLP and cGMP requirements, appropriate regulatory guidance and current industry practices for analytical development.
Experience authoring analytical modules for regulatory submissions in all phases of development.
Hands-on experience with LCMS identification and qualification of impurities and degradation products is preferred.
Experience with setting specifications for drug substances and drug products and qualifying reference standards.
Demonstrated scientific excellence, technical leadership, and creativity.
Proven project management skills and productive collaboration with cross-functional teams.
Ability to deliver under tight timelines and adapt to changing project needs. Detailed and timely data review is a key element of this position.
Ability to work on multiple projects at the same time.
Ability to communicate, organize, and write well.
Salary range:
$165,000 - $195,000, title and salary commensurate with experience
Our Benefits:
We are proud to offer health benefits, a discretionary bonus plan, stock option grants, a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.
Application Process:
There is no deadline because the employer accepts applications on an ongoing basis. Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.
#J-18808-Ljbffr