Senior Director, Drug Product Development

hace 1 mes

Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completo

Senior Director, Drug Product Development (Small Molecules)Scorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and data sciences, with the goal of consistently and rapidly creating exquisitely selective small molecule compounds against an unprecedented spectrum of targets. Scorpion aims to leverage its platform to advance a broad pipeline of wholly owned, optimized compounds across three target categories: best-in-class molecules targeting validated oncogene targets; first-in-class molecules for previously undruggable targets; and first-in-class molecules for novel cancer targets.
Responsibilities This role is responsible for the design, optimization, and manufacture of phase-appropriate small molecule drug products to support non-clinical (Discovery support, animal safety studies) and clinical development programs (Phase 1 to commercial). The role also has responsibility for line-of-sight to commercially viable manufacturing processes, including selection of appropriate container closure systems.The role will also provide technical expertise and guidance regarding pre-formulation activities for internal scientists within Scorpion Discovery teams to enable in vivo evaluation of lead compounds.This role will include travel to CDMO sites as required for project meetings, due diligence activities and manufacture.Key aspects of the role are: Key member of Project Development Teams, collaborate and partner closely with CMC project management, drug substance SMEs, DMPK/toxicology, clinical operations, regulatory and quality.Execute physico-chemical characterizations, chemical stability assessments, and pre-formulation development activities for small molecule lead compounds.Lead and manage outsourcing activities (formulation/product development and manufacturing) at global CDMO sites, in alignment with program goals.Design drug product R&D and cGMP stability studies to support product development.Act as key product SME for the successful execution of technology transfer of drug product processes to manufacturing site(s), providing technical input/insights to the CDMOs.Create, review, and approve specifications, batch records and other critical development/cGMP documents.Author, review, and complete drug product sections of regulatory documents (IND, IMPD).Foster strong team spirit and promote knowledge exchange within and between teams.Support Discovery with evaluation of dosing solutions, stability studies, outsourcing activities and evaluate novel formulation technologies to assure the most appropriate delivery of compounds for in vivo studies.As a part of the CMC development team, evaluate and select the most suitable physical forms of compounds entering development and define formulation strategies for successful transfer from Discovery to Development.Contribute to evaluation of new scientific technologies and various innovative initiatives within the team.Report and present scientific/technical results internally and contribute to publications, presentations and patents.Qualifications Degree in Pharmaceutical Sciences, Chemistry or Engineering with at least 10 years of life sciences industry experience.Expertise in phase-appropriate formulation development and manufacture.Knowledge of current Good Manufacturing Practices and experience in leading manufacture under cGMP.Strong verbal, written and communications skills as well as a collaborative spirit are essential.Direct experience of interactions with CDMOs and manufacturing operations.Proven success working in cross-functional teams.Strong scientific background and knowledge of the drug development process.Experience in the application of scientific tools such as design of experiments (DoE) to facilitate efficient drug development.Skill in fostering open communication, mutual understanding, and cooperation.Strong understanding of productivity tools, Power Point, Excel, Word along with other related software.Experience in managing multiple programs at one time, can work well with different management styles to keep a project moving.Competency in developing, implementing, and delivering CMC project plans (milestones, timelines, resources, etc.) to successful endpoints.Self-directed, accomplishment-driven individual with a strong sense of passion and urgency who can work both independently and in a cross- functional team environment.Experience in developing and commercializing drugs for oncology is an advantage.Scorpion Therapeutics Inc. is an Equal Opportunity Employer who strives to create and maintain a diverse working environment. We do not discriminate for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

#J-18808-Ljbffr

  • Senior Director, Drug Product Development

    hace 2 semanas

    Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo

    Job SummaryScorpion Therapeutics Inc. is seeking a highly experienced Senior Director, Drug Product Development to join our team. This role will be responsible for the design, optimization, and manufacture of phase-appropriate small molecule drug products to support non-clinical and clinical development programs.Key ResponsibilitiesDesign, optimize, and...

  • Senior Director, Sport Development

    hace 1 mes

    Puerto Diablo, Puerto Rico Buscojobs PR C2 A tiempo completo

    Senior Director, Sport Development & Product About the Company National governing body of youth sports IndustrySports TypeNon Profit Founded2002 Employees51-200 Categories Sporting GoodsCollege FootballFootballIndianaNCAASports Specialties grantsrulestraininghealth and safetyand health and safety Business Classifications B2C About the Role The Company is...

  • Vice President, Formulation

    hace 2 meses

    Puerto Diablo, Puerto Rico Buscojobs PR C2 A tiempo completo

    Vice President, Formulation & Drug Product Development About the Company Pioneering biotechnology (BioTech) company specializing in therapies for immunological & inflammatory disorders IndustryBiotechnology TypePublic Company Founded2022 Employees201-500 Categories BiotechnologyPharmaceuticalsAcademic ResearchHealth CareHealth &...

  • Associate Director, Sterile Drug Products

    hace 1 mes

    Puerto Diablo, Puerto Rico Biospace, Inc. A tiempo completo

    Job Details Position Overview: We are seeking a highly motivated and experienced Associate Director to lead sterile drug product development and manufacturing activities. This role focuses on ensuring the highest quality standards and regulatory compliance for late-stage development to commercialization of biologics. You will play a key role in vendor...

  • Senior Director Of Business Development

    hace 3 meses

    Puerto Diablo, Puerto Rico Buscojobs PR C2 A tiempo completo

    Senior Director of Business Development About the Company Well-established multinational pharmaceutical CDMO IndustryPharmaceuticals TypePrivately Held About the Role The Company is seeking a Senior Director of Business Development to lead its commercial and business strategies in the East Coast region. The successful candidate will be responsible for...

  • Business Development Director for AI-Driven Drug Discovery

    hace 4 semanas

    Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo

    Job Summary1910 Genetics is a pioneering biotechnology company that has developed a novel AI-driven drug discovery platform. We are seeking a highly experienced Business Development Director to join our team and capitalize on our proprietary technology platform and internal pipeline of drug candidates.Key Responsibilities Work closely with our senior...

  • Senior Director/Vice President, Business Development and Commercial Strategy

    hace 4 semanas

    Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo

    Job SummaryThe Senior Director/Vice President of Business Development and Commercial Strategy will be a key member of the leadership team at Scorpion Therapeutics Inc., responsible for driving the company's business development strategy, forging strategic partnerships, and advancing the company's product pipeline through informed decision-making, commercial...

  • Senior Director, Product

    hace 1 mes

    Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completo

    The Dana-Farber Cancer Institute (DFCI) is seeking a visionary leader to join our team as the Senior Director of Product and Technology, serving our esteemed research community. This pivotal role reports directly to the Vice President (VP) of Research Informatics Operations (RIO) and plays a critical role in the development, implementation, and continuous...

  • Associate Director/Director Development Program Management

    hace 1 mes

    Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completo

    Associate Director/Director, Development Program Management Boston, MA, USA Req #303 Tuesday, August 13, 2024 Who We Are: Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with...

  • Executive Director, Drug Safety Physician

    hace 3 meses

    Puerto Diablo, Puerto Rico Buscojobs PR C2 A tiempo completo

    Executive Director, Drug Safety Physician About the Company Pioneering biopharmaceutical company specializing in RNA-targeted drug discovery IndustryBiotechnology TypePublic Company Founded1989 Employees201-500 Specialties antisense drug discovery Business Classifications B2C About the Role The Company is seeking an Executive Director, Drug Safety...

  • Senior Director, Regulatory Cmc

    hace 1 mes

    Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completo

    Senior Director, Regulatory CMC PepGen is at an exciting time in our development. This role is for a motivated and team-oriented individual who flourishes in an environment where they can help lead and shape our future.As an integrated member of the PepGen Team, you will lead, develop, and implement robust regulatory CMC strategies and provide advice on the...

  • Senior Product Design Director

    hace 2 semanas

    Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo

    Lead Product Design and StrategyKlaviyo is seeking an experienced Senior Product Design Director to lead our product design team and drive the development of our e-commerce platform.Responsibilities:Lead a team of experienced product designers to execute on company goals.Mentor and manage a world-class team, establishing clear standards for performance and...

  • Scientist, Formulation and Drug Product Development Expert

    hace 2 semanas

    Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo

    About the RoleWe are seeking a highly skilled and experienced Sr. Scientist, Formulation & Drug Product Development to join our Technical Development Operations group. As a key member of our team, you will lead the formulation development of lentiviral vectors, including the design, optimization, and scale-up of LVV formulations.Key ResponsibilitiesLead the...

  • Senior Director of Product and Technology

    hace 2 semanas

    Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo

    Job Title: Senior Director of Product and TechnologyAbout the Role:We are seeking a visionary leader to join our team as the Senior Director of Product and Technology. This pivotal role reports directly to the Vice President (VP) of Research Informatics Operations (RIO) and plays a critical role in the development, implementation, and continuous enhancement...

  • Sr. Scientist, Formulation

    hace 1 mes

    Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completo

    Here at Kelonia Therapeutics, we aren't just a preclinical company; we're trailblazers in viral engineering, pushing the boundaries of in vivo lentiviral gene and cell therapy. We're not just a team; we're dreamers on a mission to bring the promise of cell and gene therapy to every patient in need. At Kelonia, we've gathered a group of pioneers in cell and...

  • Senior Director Of Development

    hace 1 mes

    Puerto Diablo, Puerto Rico Buscojobs PR C2 A tiempo completo

    Senior Director of Development About the Company Mission-driven organization advancing glaucoma research & providing patient education resources IndustryNon-Profit Organization Management TypeNon Profit Founded1978 Employees11-50 Specialties Glaucoma Research Project FundingPatient Education for glaucomaAnnual Glaucoma Symposium and Forumand Publicly...

  • Director, Pharmacovigilance And Drug Safety

    hace 1 mes

    Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completo

    Director, Pharmacovigilance and Drug Safety (Safety Science) Boston, MA, USA Req #259 Friday, July 12, 2024 Who We Are: Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological...

  • Director Of Product

    hace 3 meses

    Puerto Diablo, Puerto Rico Buscojobs PR C2 A tiempo completo

    Director of Product About the Company Top hardware crypto wallet IndustryInternet TypePrivately Held About the Role The Company is in search of a Director of Product to spearhead the definition, maintenance, and creation of the highest standards for its future product portfolio, with a focus on both hardware and software levels. The successful candidate will...

  • Senior Director, Medical Affairs

    hace 1 mes

    Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completo

    Senior Director, Medical Affairs (Medical and Scientific Ops) Boston, MA, USA Req #235 Thursday, March 7, 2024 Who We Are: Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with...

  • Vice President, Product Development

    hace 3 meses

    Puerto Diablo, Puerto Rico Buscojobs PR C2 A tiempo completo

    Vice President, Product Development About the Company Flourishing biopharmaceutical company IndustryBiotechnology TypePrivately Held, VC-backed Founded2019 Employees11-50 Funding$101-$200 million Categories ManufacturingPharmaceuticalsMedicineChemical ProductsBiotechnologyHealth CareTherapeuticsWellness About the Role The Company is in search of a Vice...