Current jobs related to Director of Small Molecule Development - Reston, Virginia - Meet
-
Quality Assurance Specialist
2 weeks ago
Reston, Virginia, United States Barrington James Full timeWe are seeking an experienced Quality Assurance Reviewer with a strong background in both biologics and small molecules to play a crucial role in ensuring the highest standards of product quality, regulatory compliance, and manufacturing processes.Key Responsibilities:Review batch production records, quality control data, and associated documentation for...
-
Process Development Engineer
3 weeks ago
Reston, Virginia, United States Molecule Works Inc. Full timeAbout Molecule Works Inc.Molecule Works Inc. is a pioneering technology company that designs and manufactures innovative products for energy efficiency and clean energy applications. Our cutting-edge solutions include proprietary porous metal sheet membranes, thin ceramic membranes, and electrochemical reactors.Job DescriptionWe are seeking a highly...
-
Senior Director Product Quality Lead
3 weeks ago
Reston, Virginia, United States Rx Group Full timeSenior Director Product QualityRx Group is seeking a highly experienced Senior Director Product Quality to join their team. This role will be responsible for leading the product quality strategy for new product classes or technical areas, with a focus on cell therapy, large molecules, and small molecules.Key Responsibilities:Develop and implement product...
-
Director of Computational Chemistry
4 weeks ago
Reston, Virginia, United States Scienta Full timeJob Title: Director of Computational ChemistryLocation: San Diego, CACompany: $70M-funded biotech startupAbout:Scienta is a cutting-edge biotech startup dedicated to advancing breakthrough treatments for cancers with critical unmet medical needs. Our platform integrates covalent ligand discovery with advanced chemical biology to target previously undruggable...
-
Regulatory Affairs Director
1 month ago
Reston, Virginia, United States Proclinical Staffing Full timeAssociate Director, Regulatory AffairsProclinical Staffing is seeking an experienced Associate Director, Regulatory Affairs to join a clinical-stage biopharmaceutical company in the San Francisco Bay Area.Key Responsibilities:Develop and implement regulatory strategies for development programs in rare diseases.Collaborate with cross-functional teams to...
-
Director of DMPK Research and Development
2 months ago
Reston, Virginia, United States BioPhase Full timeAbout the RoleWe are seeking a highly motivated and experienced Director of DMPK to join our dynamic drug discovery and early development team at BioPhase. As a key member of our Preclinical R&D team, you will work closely with our DMPK, biology, and chemistry teams to drive early discovery research programs into early clinical development.Key...
-
Reston, Virginia, United States Tempest Therapeutics Full timeSummary and Scope: We are seeking a seasoned professional to lead the drug product technical development plan for all products in Tempest's pipeline. As the Associate Director/Director, Drug Product Process Development, you will collaborate closely with cross-functional teams to drive innovative therapies and improve patient lives.Key Responsibilities:...
-
Senior Director Product Quality Lead
2 weeks ago
Reston, Virginia, United States Rx Group Full timeRx Group is seeking a Senior Director Product Quality to lead the product quality strategy for new product classes or technical areas, with a focus on cell therapy, large molecules, and small molecules.Key Responsibilities:Product Quality Strategy: Develop and implement end-to-end quality plans from preclinical stages through commercial launch, ensuring...
-
CMO Leadership Director
4 days ago
Reston, Virginia, United States Meet Full timeJob Title: Senior Director, CMCJob Summary:A highly experienced and motivated Senior Director, CMC is sought to lead and oversee CMC activities related to drug substance and drug product development, manufacturing, and supply chain. The successful candidate will play a critical role in leading and overseeing CMC activities and have deep expertise in small...
-
Senior Director, Pharmaceutical Development
2 months ago
Reston, Virginia, United States Bayside Solutions Full timeJob Summary:We are seeking a highly experienced Senior Director to lead our drug product development activities, playing a critical role as the technical lead and CMC project lead. This position will be responsible for leading drug product development activities leading to NDA submission and commercialization, and developing and executing the CMC...
-
Senior Director of Cancer Pharmacology
2 months ago
Reston, Virginia, United States Bayside Solutions Full timeSenior Director, Cancer PharmacologyAbout the RoleWe are seeking a highly experienced Senior Director to lead our Cancer Pharmacology team. As a key member of our research and development team, you will be responsible for providing strategic and technical leadership in the translation research group and multi-disciplinary research and development project...
-
Senior DMPK Research Director
2 weeks ago
Reston, Virginia, United States BioPhase Full timeWe are seeking a highly motivated and experienced Director of DMPK to lead our drug discovery and early development team in San Diego. Reporting to the Executive Director of Preclinical R&D, the successful candidate will work closely with the DMPK, biology, and chemistry teams to drive early discovery research programs into early clinical development.The...
-
Reston, Virginia, United States Terns Pharmaceuticals Full timeAbout the RoleTerns Pharmaceuticals is seeking a highly skilled Senior Regulatory Affairs and Quality Assurance Director to lead our regulatory and quality functions. As a key member of our Senior Leadership Team, you will be responsible for developing and executing regulatory strategies, managing global health authority interactions, and overseeing quality...
-
Regulatory Affairs Director
2 months ago
Reston, Virginia, United States Hamlyn Williams Full timeSenior Director, Regulatory AffairsHamlyn Williams is partnering with a pioneering biopharmaceutical company to fill a key leadership role in their regulatory affairs department.About the RoleProvide strategic guidance on regulatory strategies, clinical study requirements, and marketing approvals across various regions.Lead and mentor a high-performing...
-
Clinical Research Associate
4 days ago
Reston, Virginia, United States BlossomHill Therapeutics, Inc. Full timeAbout Us:BlossomHill Therapeutics is pioneering precision medicine to transform cancer treatment and improve lives.Our mission is to develop innovative therapies that address cancer's resistance to treatment from multiple angles. With a focus on small-molecule masterpieces, we aim to set new standards for cancer treatment.Job Summary:We seek a Clinical...
-
Reston, Virginia, United States BioPhase Full timeJob OverviewWe are seeking a skilled and passionate Senior Research Associate to join our dynamic team at BioPhase. This is an exciting opportunity to contribute to the discovery and development of small molecule therapeutics in a well-funded, small company environment.Key Responsibilities:Design and execute experiments to develop scientifically sound...
-
Senior Analytical Research Scientist
2 weeks ago
Reston, Virginia, United States Astrix Full timeAt Astrix, we're seeking a highly skilled Senior Analytical Research Scientist to join our team of experts in chemical-based industries. This role involves developing and validating HPLC and GC procedures for small molecule drug substances and drug products.Key Responsibilities:Develop and validate HPLC and GC procedures for small molecule drug substances...
-
Business Development Director
3 weeks ago
Reston, Virginia, United States Agility Technologies Inc Full timeJob OverviewAgility Technologies Inc. is seeking a seasoned Business Development Director to lead our Federal-Civilian Accounts growth strategy. As a key member of our Growth team, you will contribute to high growth in assigned accounts by leveraging relationships and insight to identify, capture, and win new business opportunities.Key...
-
Study Director
2 months ago
Reston, Virginia, United States AmplifyBio Full timeAbout the RoleWe are seeking a highly skilled Study Director to join our team at AmplifyBio, a leading contract research organization. As a Study Director, you will be responsible for overseeing the scientific elements of projects, ensuring successful implementation and completion of non-clinical studies.Key ResponsibilitiesLead toxicology, biodistribution,...
-
Quality Assurance Specialist
1 month ago
Reston, Virginia, United States Barrington James Full timeQuality Assurance SpecialistBarrington James is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will play a crucial role in ensuring the highest standards of product quality, regulatory compliance, and manufacturing processes.Key Responsibilities:Review batch production records,...
Director of Small Molecule Development
2 months ago
Meet's esteemed biotech partner has collaborated with us on a groundbreaking new search for a Director of Drug Substance Development. As a key member of our veteran CMC group, you will oversee CRO/CMO activities for small molecule drug substance development across early and late stages. This is an exceptional opportunity to contribute to the development and commercialization of oncology and immunology therapies.
Key Responsibilities:
- Lead small molecule API CMO activities in phase-appropriate development, ensuring seamless collaboration with internal and external teams.
- Troubleshoot complex issues and work cross-functionally to resolve them.
- Author and contribute to writing CMC sections of regulatory documents, including NDA/IND/IMPD/MAA.
- Assess and implement novel strategies, considering scalability, robustness, and feasibility in a cGMP environment.
Requirements:
- PhD in Organic Chemistry or a related field, with 10+ years of experience in the pharmaceutical/biotech industry in small molecule development.
- Process validation experience is mandatory, with authoring/supporting NDA filings being a significant plus.
- Experience mentoring/managing chemists in a lab environment is highly valued.
If you are interested in advancing your career, please contact Cayla Koch for more information about this opportunity. This will be handled confidentially.
