Director, Analytical Development
Scorpion Therapeutics, Boston, MA, United States
Role Summary
Director of Analytical Development, reporting to the Senior Director, Analytical Chemistry. Responsible for driving progress of both early and late-stage molecules by delivering phase-appropriate analytical methods and validation, driving method innovation, ensuring alignment with regulatory expectations, and partnering cross-functionally to support process development, formulation, CMC, and quality activities. Based in either San Francisco or Boston, with 10% travel.
Responsibilities
Oversee analytical method development, qualification, and validation for starting materials, in-process control, process intermediates, drug substances and drug products
Conduct analytical technical review of method validation/qualification protocols, data and reports generated at CDMOs for drug substances and drug products
Review and approve analytical reports or certificates of analyses from CDMOs for batch release and stability testing of drug substances and drug products
Manage stability programs, monitor trending stability data and establish retest periods or shelf lives for drug substances or drug products
Provide technical input and resolve analytical and quality control issues, deviations, OOS and OOT investigations
Author and review appropriate CMC sections to support regulatory filings (IND, IMPD, NDA, MAA) submissions
Represent Analytical Chemistry at internal and external scientific team meetings as needed
Remain current with state-of-the art approaches and applicable global regulations and industry standards
Qualifications
PhD with a minimum of 10+ years of relevant industry experience or an MS with a minimum of 12+ years of relevant industry experience in small molecule drug substance and drug product analytical development and quality control, including late-stage clinical development and preparation for product registration
Minimum of 5 years direct leadership experience on managing internal and external teams
Expertise of cGMP, ICH, and FDA regulations/guidance
Demonstrated experience in authoring and reviewing documents in support of CMC development activities and regulatory submissions (IND/IMPD, information requests, amendments, briefing books, NDA/MAA, etc.)
Experience in developing internal technical capabilities and driving CDMO performance to meet critical project milestones
Experience in partnering with cross functional teams providing analytical development leadership across programs and projects
Demonstrated interpersonal skills, including strong oral and written communication abilities
Skills
A high level of curiosity, intelligence, ability to work independently, “can do” attitude, and ability to work cross-functionally
Aspires to the highest of scientific and ethical standards
Ability to multi-task and shift priorities rapidly to meet tight deadlines
Keen to improve processes and overcome inefficiencies
Education
PhD or MS in a discipline relevant to analytical chemistry, pharmaceutical sciences, or related field
Additional Requirements
Travel: 10% travel required
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Responsibilities
Oversee analytical method development, qualification, and validation for starting materials, in-process control, process intermediates, drug substances and drug products
Conduct analytical technical review of method validation/qualification protocols, data and reports generated at CDMOs for drug substances and drug products
Review and approve analytical reports or certificates of analyses from CDMOs for batch release and stability testing of drug substances and drug products
Manage stability programs, monitor trending stability data and establish retest periods or shelf lives for drug substances or drug products
Provide technical input and resolve analytical and quality control issues, deviations, OOS and OOT investigations
Author and review appropriate CMC sections to support regulatory filings (IND, IMPD, NDA, MAA) submissions
Represent Analytical Chemistry at internal and external scientific team meetings as needed
Remain current with state-of-the art approaches and applicable global regulations and industry standards
Qualifications
PhD with a minimum of 10+ years of relevant industry experience or an MS with a minimum of 12+ years of relevant industry experience in small molecule drug substance and drug product analytical development and quality control, including late-stage clinical development and preparation for product registration
Minimum of 5 years direct leadership experience on managing internal and external teams
Expertise of cGMP, ICH, and FDA regulations/guidance
Demonstrated experience in authoring and reviewing documents in support of CMC development activities and regulatory submissions (IND/IMPD, information requests, amendments, briefing books, NDA/MAA, etc.)
Experience in developing internal technical capabilities and driving CDMO performance to meet critical project milestones
Experience in partnering with cross functional teams providing analytical development leadership across programs and projects
Demonstrated interpersonal skills, including strong oral and written communication abilities
Skills
A high level of curiosity, intelligence, ability to work independently, “can do” attitude, and ability to work cross-functionally
Aspires to the highest of scientific and ethical standards
Ability to multi-task and shift priorities rapidly to meet tight deadlines
Keen to improve processes and overcome inefficiencies
Education
PhD or MS in a discipline relevant to analytical chemistry, pharmaceutical sciences, or related field
Additional Requirements
Travel: 10% travel required
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