Tbwa Chiat/Day Inc
Executive Director and Head of Small Molecule Drug Substance
Tbwa Chiat/Day Inc, Oklahoma City, Oklahoma, United States,
Executive Director and Head of Small Molecule Drug Substance
Massachusetts - hybrid Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA. COMPANY OVERVIEW: Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires. POSITION OVERVIEW: As Disc Medicine evolves from a clinical to a commercial-stage organization, the Company has a new role as an Executive Director and Head of Small Molecule Drug Substance, reporting to the Chief Technical Officer. The successful candidate will be instrumental in driving the company’s growth trajectory and achieving strategic objectives. The Executive Director and Head of Small Molecule Drug Substance will provide deep technical oversight over all small drug substance process development and manufacturing activities. This role includes designing and conducting process development, process characterization, and process validation studies at external manufacturing sites. A significant technical contribution is expected from this role to enable IND and NDA filings of Disc Medicine assets. This position requires a Ph.D. and at least 15 years of industry experience in API process development. RESPONSIBILITIES: Lead drug substance process development and process characterization for small molecule programs. Provide technical leadership for validation campaigns for small molecule drug substance. Develop and optimize scalable chemical processes for the synthesis of drug substance, focusing on yield, efficiency, and purity. Critically review and approve relevant technical documents, including manufacturing, scaleup, and validation protocols, process development and characterization reports, and associated plans. This role will be the small molecule DS lead on CMC teams and interface closely across the internal CMC leader and external Contract Development & Manufacturing Organization (CDMO) teams. Provide critical technical input to enable relevant CMC sections of the NDA, including authoring reports and sections as well as reviewing relevant sections. Provide effective technical responses to questions raised by health authorities. Be the Person-In-Plant (PIP) for small molecule DS manufacturing campaigns at CDMOs. Form effective relationships and collaborate well with the CMC leader and internal functions, including drug product, analytical development, Quality assurance, Quality control, and regulatory CMC. Develop and manage the DS budget and implement continuous improvement initiatives to reduce the cost of goods, improve product quality as needed, and manage the DS lifecycle for risk reduction. Enable success of clinical and commercial GMP campaigns; ability to provide technical leadership to resolve deviations that may arise during manufacturing. Develop long-term DS manufacturing process and network strategy to support near and long-term supply projections. REQUIREMENTS: Advanced degree in relevant scientific discipline; Ph.D. in Chemistry or Chemical Engg preferred. 15+ years of relevant small molecule process development and manufacturing technical oversight experience, including hands-on experience. Demonstrated record of leading small molecule API process development, resulting in robust and scalable processes. Proven record of conducting process characterization and validation-related studies and providing oversight of Process Performance Qualification (PPQ) campaigns. Deep experience in drafting, reviewing, and helping file regulatory submissions, particularly NDA submissions. Substantial experience in working in CMC teams – with CMC leaders and related team leaders. Experience in CDMO relationship management, have significant network expertise in this space. Ability to provide technical guidance to CDMOs; proactively escalate issues to management and provide solution proposals. Strong understanding of FDA, EMA, and ICH guidelines. Excellent collaboration and interpersonal skills. Ability to convey complex ideas succinctly. Disc Medicine is an equal-opportunity employer committed to providing all qualified candidates and employees equal opportunities. We offer comprehensive benefits and competitive compensation packages. The Company headquarters are in Watertown, MA, and we provide a flexible work environment. Disc Medicine actively recruits individuals with an entrepreneurial spirit and a drive for excellence. Interested candidates should submit a cover letter and resume to be considered for current and future opportunities.
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Massachusetts - hybrid Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA. COMPANY OVERVIEW: Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires. POSITION OVERVIEW: As Disc Medicine evolves from a clinical to a commercial-stage organization, the Company has a new role as an Executive Director and Head of Small Molecule Drug Substance, reporting to the Chief Technical Officer. The successful candidate will be instrumental in driving the company’s growth trajectory and achieving strategic objectives. The Executive Director and Head of Small Molecule Drug Substance will provide deep technical oversight over all small drug substance process development and manufacturing activities. This role includes designing and conducting process development, process characterization, and process validation studies at external manufacturing sites. A significant technical contribution is expected from this role to enable IND and NDA filings of Disc Medicine assets. This position requires a Ph.D. and at least 15 years of industry experience in API process development. RESPONSIBILITIES: Lead drug substance process development and process characterization for small molecule programs. Provide technical leadership for validation campaigns for small molecule drug substance. Develop and optimize scalable chemical processes for the synthesis of drug substance, focusing on yield, efficiency, and purity. Critically review and approve relevant technical documents, including manufacturing, scaleup, and validation protocols, process development and characterization reports, and associated plans. This role will be the small molecule DS lead on CMC teams and interface closely across the internal CMC leader and external Contract Development & Manufacturing Organization (CDMO) teams. Provide critical technical input to enable relevant CMC sections of the NDA, including authoring reports and sections as well as reviewing relevant sections. Provide effective technical responses to questions raised by health authorities. Be the Person-In-Plant (PIP) for small molecule DS manufacturing campaigns at CDMOs. Form effective relationships and collaborate well with the CMC leader and internal functions, including drug product, analytical development, Quality assurance, Quality control, and regulatory CMC. Develop and manage the DS budget and implement continuous improvement initiatives to reduce the cost of goods, improve product quality as needed, and manage the DS lifecycle for risk reduction. Enable success of clinical and commercial GMP campaigns; ability to provide technical leadership to resolve deviations that may arise during manufacturing. Develop long-term DS manufacturing process and network strategy to support near and long-term supply projections. REQUIREMENTS: Advanced degree in relevant scientific discipline; Ph.D. in Chemistry or Chemical Engg preferred. 15+ years of relevant small molecule process development and manufacturing technical oversight experience, including hands-on experience. Demonstrated record of leading small molecule API process development, resulting in robust and scalable processes. Proven record of conducting process characterization and validation-related studies and providing oversight of Process Performance Qualification (PPQ) campaigns. Deep experience in drafting, reviewing, and helping file regulatory submissions, particularly NDA submissions. Substantial experience in working in CMC teams – with CMC leaders and related team leaders. Experience in CDMO relationship management, have significant network expertise in this space. Ability to provide technical guidance to CDMOs; proactively escalate issues to management and provide solution proposals. Strong understanding of FDA, EMA, and ICH guidelines. Excellent collaboration and interpersonal skills. Ability to convey complex ideas succinctly. Disc Medicine is an equal-opportunity employer committed to providing all qualified candidates and employees equal opportunities. We offer comprehensive benefits and competitive compensation packages. The Company headquarters are in Watertown, MA, and we provide a flexible work environment. Disc Medicine actively recruits individuals with an entrepreneurial spirit and a drive for excellence. Interested candidates should submit a cover letter and resume to be considered for current and future opportunities.
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