Tbwa Chiat/Day Inc
Senior Scientist, CMC Technical Operations (Formulation Expertise)
Tbwa Chiat/Day Inc, Oklahoma City, Oklahoma, United States,
Senior Scientist, CMC Technical Operations (Formulation Expertise)
Massachusetts - HybridJoin 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:The Senior Scientist, CMC Technical Operations with expertise in formulation is responsible for leading the formulation development and manufacturing process of drug products. This role focuses on the technical oversight of drug formulation, process development, scale-up, and technology transfer activities. The Senior Scientist will work closely with Contract Development and Manufacturing Organizations (CDMOs), providing expertise in formulation and ensuring the successful development of high-quality drug products.This role requires extensive knowledge of drug formulation, delivery systems, and manufacturing processes, with a focus on developing innovative formulations for small molecules. The Senior Scientist will collaborate across functions, including R&D, regulatory affairs, and quality assurance, to drive formulation strategies from early-stage development through commercialization.RESPONSIBILITIES:Lead formulation development efforts for drug products, including small molecules.Provide scientific expertise in designing and optimizing formulations, evaluating various delivery systems (e.g., oral, injectable, topical), and ensuring the stability and efficacy of drug products.Support formulation screening and characterization studies, overseeing experimental design, data analysis, and interpretation.Collaborate with internal teams and CDMOs to develop robust, scalable manufacturing processes for drug formulations.Oversee technology transfer activities for formulations, ensuring seamless transfer of processes from development to commercial-scale manufacturing.Collaborate with CDMOs to resolve technical challenges in formulation and manufacturing, ensuring processes are optimized for quality, efficiency, and regulatory compliance.Serve as the formulation lead for CMC activities, including authoring and reviewing technical sections of regulatory filings (INDs, NDAs, BLAs).Lead the preparation of CMC documents, ensuring alignment with regulatory requirements and industry best practices for formulation development.Collaborate with cross-functional teams (R&D, quality, regulatory) to ensure formulation development aligns with the overall CMC strategy.Function as the primary technical point of contact for CDMOs, overseeing formulation development, manufacturing, and process validation activities.Provide technical oversight for formulation and manufacturing projects, ensuring CDMOs meet the company’s quality, timeline, and budget expectations.Review and approve technical reports, batch records, process validation protocols, and deviation investigations related to formulation processes.Ensure all formulation and manufacturing activities comply with regulatory guidelines (FDA, EMA, ICH) and Good Manufacturing Practices (GMP).Contribute to regulatory submissions by providing scientific data and technical reports related to formulation development.Support quality assurance teams in audits and inspections related to formulation and manufacturing processes.Stay current with the latest advancements in drug formulation, delivery systems, and manufacturing technologies.Identify opportunities for innovation in drug formulation and contribute to process improvements that enhance product quality and manufacturing efficiency.Drive the development of novel formulation approaches to improve drug solubility, stability, and bioavailability.REQUIREMENTS:PhD in pharmaceutical sciences, chemistry, chemical engineering, or a related field. Master’s degree with extensive experience in formulation development may also be considered.5-6 years of relevant experience in pharmaceutical oral formulation development, with experience in both early- and late-stage drug product development.Proven track record of leading formulation development for small molecules drug products.Experience managing CDMOs and overseeing formulation-related activities in a CMC or manufacturing setting.In-depth knowledge of pharmaceutical formulation science, drug delivery systems, and manufacturing processes.Strong understanding of regulatory requirements for CMC, including knowledge of FDA, EMA, and ICH guidelines.Excellent project management skills with the ability to lead cross-functional teams and manage external partnerships.Ability to troubleshoot formulation and manufacturing challenges and provide innovative technical solutions.Effective communication skills, with the ability to clearly present complex technical information to both internal teams and external partners.Experience with formulation development for small molecule drugs.Experience with regulatory filings (IND, NDA, BLA).Familiarity with advanced formulation technologies (e.g., amorphous solid dispersions, controlled-release systems).This role may require occasional travel to CDMO sites for technical oversight and collaboration.The position involves cross-functional collaboration and leadership in CMC activities, requiring a strong blend of technical expertise and project management skills.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.
#J-18808-Ljbffr
Massachusetts - HybridJoin 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:The Senior Scientist, CMC Technical Operations with expertise in formulation is responsible for leading the formulation development and manufacturing process of drug products. This role focuses on the technical oversight of drug formulation, process development, scale-up, and technology transfer activities. The Senior Scientist will work closely with Contract Development and Manufacturing Organizations (CDMOs), providing expertise in formulation and ensuring the successful development of high-quality drug products.This role requires extensive knowledge of drug formulation, delivery systems, and manufacturing processes, with a focus on developing innovative formulations for small molecules. The Senior Scientist will collaborate across functions, including R&D, regulatory affairs, and quality assurance, to drive formulation strategies from early-stage development through commercialization.RESPONSIBILITIES:Lead formulation development efforts for drug products, including small molecules.Provide scientific expertise in designing and optimizing formulations, evaluating various delivery systems (e.g., oral, injectable, topical), and ensuring the stability and efficacy of drug products.Support formulation screening and characterization studies, overseeing experimental design, data analysis, and interpretation.Collaborate with internal teams and CDMOs to develop robust, scalable manufacturing processes for drug formulations.Oversee technology transfer activities for formulations, ensuring seamless transfer of processes from development to commercial-scale manufacturing.Collaborate with CDMOs to resolve technical challenges in formulation and manufacturing, ensuring processes are optimized for quality, efficiency, and regulatory compliance.Serve as the formulation lead for CMC activities, including authoring and reviewing technical sections of regulatory filings (INDs, NDAs, BLAs).Lead the preparation of CMC documents, ensuring alignment with regulatory requirements and industry best practices for formulation development.Collaborate with cross-functional teams (R&D, quality, regulatory) to ensure formulation development aligns with the overall CMC strategy.Function as the primary technical point of contact for CDMOs, overseeing formulation development, manufacturing, and process validation activities.Provide technical oversight for formulation and manufacturing projects, ensuring CDMOs meet the company’s quality, timeline, and budget expectations.Review and approve technical reports, batch records, process validation protocols, and deviation investigations related to formulation processes.Ensure all formulation and manufacturing activities comply with regulatory guidelines (FDA, EMA, ICH) and Good Manufacturing Practices (GMP).Contribute to regulatory submissions by providing scientific data and technical reports related to formulation development.Support quality assurance teams in audits and inspections related to formulation and manufacturing processes.Stay current with the latest advancements in drug formulation, delivery systems, and manufacturing technologies.Identify opportunities for innovation in drug formulation and contribute to process improvements that enhance product quality and manufacturing efficiency.Drive the development of novel formulation approaches to improve drug solubility, stability, and bioavailability.REQUIREMENTS:PhD in pharmaceutical sciences, chemistry, chemical engineering, or a related field. Master’s degree with extensive experience in formulation development may also be considered.5-6 years of relevant experience in pharmaceutical oral formulation development, with experience in both early- and late-stage drug product development.Proven track record of leading formulation development for small molecules drug products.Experience managing CDMOs and overseeing formulation-related activities in a CMC or manufacturing setting.In-depth knowledge of pharmaceutical formulation science, drug delivery systems, and manufacturing processes.Strong understanding of regulatory requirements for CMC, including knowledge of FDA, EMA, and ICH guidelines.Excellent project management skills with the ability to lead cross-functional teams and manage external partnerships.Ability to troubleshoot formulation and manufacturing challenges and provide innovative technical solutions.Effective communication skills, with the ability to clearly present complex technical information to both internal teams and external partners.Experience with formulation development for small molecule drugs.Experience with regulatory filings (IND, NDA, BLA).Familiarity with advanced formulation technologies (e.g., amorphous solid dispersions, controlled-release systems).This role may require occasional travel to CDMO sites for technical oversight and collaboration.The position involves cross-functional collaboration and leadership in CMC activities, requiring a strong blend of technical expertise and project management skills.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.
#J-18808-Ljbffr