Current jobs related to Principal Scientist, Drug Product Development - Cambridge, Massachusetts - Akebia Therapeutics
-
Principal Scientist, Drug Product Development
4 weeks ago
Cambridge, Massachusetts, United States Akebia Therapeutics Full timeJob Title: Principal Scientist, Drug Product DevelopmentAkebia Therapeutics is seeking a highly skilled Principal Scientist to join our CMC Technical Operations team. As a key member of our team, you will provide strategic and technical leadership in the development and execution of drug product strategies for our clinical and commercial programs.Key...
-
Cambridge, Massachusetts, United States Third Rock Ventures Full timeJoin Our Team as a Formulations Scientist and Drug Product LeadWe are seeking a highly skilled and innovative Formulations Scientist and Drug Product Lead to join our team at Third Rock Ventures. As a key member of our team, you will be responsible for establishing core operations and driving the development of novel protein therapeutics and dosage forms.Key...
-
Senior Analytical Development Scientist
3 weeks ago
Cambridge, Massachusetts, United States Stratacuity Full timeJob Title: Principal Scientist, Analytical DevelopmentStratacuity is seeking a highly skilled Principal Scientist to join our team in Cambridge, MA. As a key member of our Analytical Development group, you will play a critical role in guiding pharmaceutical advancements from inception through clinical stages.Key Responsibilities:Develop and implement...
-
Senior Analytical Development Scientist
1 month ago
Cambridge, Massachusetts, United States Apex Systems Full timeJob Title: Principal Scientist, Analytical DevelopmentApex Systems is seeking a highly skilled Principal Scientist, Analytical Development to join our team. As a key member of our pharmaceutical development team, you will be responsible for guiding pharmaceutical advancements from inception through clinical stages and collaborating with internal and external...
-
Senior Analytical Development Scientist
3 weeks ago
Cambridge, Massachusetts, United States Apex Systems Full timeJob Title: Principal Scientist, Analytical DevelopmentApex Systems is seeking a highly skilled Principal Scientist to join our team in Cambridge, MA. As a key member of our Analytical Development team, you will play a critical role in guiding pharmaceutical advancements from inception through clinical stages.Key Responsibilities:Develop and implement...
-
Formulations Scientist and Drug Product Lead
2 weeks ago
Cambridge, Massachusetts, United States Third Rock Ventures Full timeA Third Rock Ventures NewCo is seeking a Formulations Scientist and Drug Product Lead who will establish core operations of a new team. This laboratory-based role offers opportunities to advance programs, develop new workflows, implement devices, and build a laboratory. Successful candidates will be innovative, thrive in a startup environment, and use their...
-
Senior Principal Scientist
1 week ago
Cambridge, Massachusetts, United States Novartis Group Companies Full timeJob Description SummaryNovartis is seeking a Senior Principal Scientist to lead the Translational Medicine Drug Disposition Bioanalytical group. As a key member of the team, you will be responsible for overseeing the development, validation, and sample analysis of mass spectrometry assays for pharmacokinetic and immunogenicity bioanalysis across various...
-
Principal Scientist II, Emerging Technologies
4 weeks ago
Cambridge, Massachusetts, United States Advanced Accelerator Applications (Italy) - S... Full timeJob Title: Principal Scientist II, Emerging TechnologiesWe are seeking an innovative and dynamic Principal Scientist II with extensive expertise in neuroscience and animal behavior to join our Emerging Technologies team in Comparative Medicine. This team focuses on exploring in vivo digital biomarkers using state-of-the-art, non-invasive technologies such as...
-
Scientist - Formulation/Drug Delivery
4 weeks ago
Cambridge, Massachusetts, United States AcousticaBio Full timeScientist, Formulation/Drug DeliveryAcousticaBio is a cutting-edge deep-tech startup revolutionizing fluid processing at the microscale. We're seeking a highly skilled Scientist to join our team and contribute to the development of novel polymer/protein formulations using our proprietary acoustophoretic printing platform.Key Responsibilities:Co-lead the...
-
Principal Scientist, Protein Sciences
1 week ago
Cambridge, Massachusetts, United States Flagship Ventures Full timeRole SummaryFlagship Ventures is seeking a dedicated and skilled Principal Scientist, Protein Sciences to join our team. The role will focus on peptide or antibody production, discovery, and engineering through hit optimization and lead identification.Key ResponsibilitiesLead and manage projects focused on peptide or antibody production, discovery, and...
-
Scientist Formulation/Drug Delivery
2 weeks ago
Cambridge, Massachusetts, United States AcousticaBio Full timeScientist, Formulation/Drug Delivery | Advanced Manufacturing in Life ScienceOverview:AcousticaBio is a pioneering deep-tech startup revolutionizing fluid processing at the microscale. We're seeking a highly skilled Scientist to join our team and contribute to the development of novel polymer/protein formulations using our proprietary acoustophoretic...
-
Cambridge, Massachusetts, United States Bristol Myers Squibb Full timeTransforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Associate Director/Sr. Principal Scientist of Translational Medicine to join our team.The successful candidate will be responsible for leading...
-
Principal Scientist
2 weeks ago
Cambridge, Massachusetts, United States Novartis Group Companies Full timeAbout the Role:We are seeking a highly motivated and experienced Principal Scientist to join our interdisciplinary team at Novartis. As a key member of our team, you will be responsible for proposing, designing, and evaluating novel assays and chemotypes to tackle longstanding challenges in covalent ligand discovery.Key Responsibilities:Design and evaluate...
-
Principal Research Scientist
4 weeks ago
Cambridge, Massachusetts, United States CULLINAN ONCOLOGY LLC Full timeAbout Cullinan Oncology LLCCullinan Oncology LLC is a biopharmaceutical company dedicated to creating innovative treatments for patients. Our mission is to develop transformative therapeutics that improve patient outcomes.Job SummaryWe are seeking a highly skilled Principal Scientist/Associate Director to oversee and support early-stage drug development...
-
Principal Scientist II, Emerging Technologies
4 weeks ago
Cambridge, Massachusetts, United States Novartis Farmacéutica Full timeJob SummaryWe are seeking a highly skilled Principal Scientist II to join our Emerging Technologies team in Comparative Medicine. As a key member of our team, you will drive research programs aimed at discovering novel digital measurements and biomarkers through technologies like video monitoring.About the RoleContribute to the Biomedical Research drug...
-
Principal Scientist, Protein Sciences
1 month ago
Cambridge, Massachusetts, United States Flagship Ventures Full timeCompany OverviewFlagship Ventures is a pioneering technology company that leverages artificial intelligence to transform the scientific method. As a privately held, early-stage company, we are backed by Flagship Pioneering, which provides the resources and vision needed to achieve groundbreaking results.Job SummaryWe are seeking a highly skilled Principal...
-
Senior/Principal Scientist, Biology
2 weeks ago
Cambridge, Massachusetts, United States Crossbow Therapeutics, Inc Full timeCrossbow Therapeutics, Inc. is a biotechnology company dedicated to improving the lives of people with cancer by unlocking the therapeutic potential of T-cell receptor (TCR)-mimetic antibodies. Our T-BoltTM therapies are next-generation, easily assembled immunotherapies directed with high precision at previously unreachable cancer cell targets. Our approach...
-
Cambridge, Massachusetts, United States Flagship Pioneering Full timeCompany Overview:Flagship Pioneering is a bioplatform innovation company that invents and builds platform companies, each with the potential for multiple products that transform human health or sustainability. With a proven track record of success, Flagship has originated and fostered over 100 scientific ventures, resulting in over $90 billion in aggregate...
-
Cambridge, Massachusetts, United States Flagship Pioneering Full timeCompany Overview:Flagship Pioneering is a bioplatform innovation company that invents and builds platform companies, each with the potential for multiple products that transform human health or sustainability. With a strong focus on innovation and entrepreneurship, Flagship has originated and fostered over 100 scientific ventures, resulting in over $90...
-
Principal Scientist, Discovery Biology
3 weeks ago
Cambridge, Massachusetts, United States Flagship Ventures Full timeTransforming Drug Discovery with Flagship PioneeringAt Flagship Pioneering, we are dedicated to transforming drug discovery by leveraging deep biological insights and cutting-edge scientific innovations. Our mission is to deliver breakthrough therapies that address critical unmet medical needs.Job SummaryWe are seeking an experienced and highly motivated...
Principal Scientist, Drug Product Development
2 months ago
We are seeking a highly skilled and experienced Principal Scientist, Drug Product Development to join our CMC Technical Operations team at Akebia Therapeutics. As a key member of our team, you will be responsible for providing strategic and technical leadership in the development and execution of drug product strategies for our clinical and commercial programs.
Key Responsibilities- Provide strategic, technical, and managerial leadership in the development and execution of drug product strategies for the development, optimization, scale-up, and manufacturing for Akebia's clinical and commercial programs.
- Lead project teams by providing oversight of project milestones, drive activities with additional project team members, manage timelines, contracts and invoices, and accountability for entire project.
- Collaborate with Akebia cross-functional teams to support overall program strategies, goals, and objectives.
- Manage and oversee activities at contract organizations worldwide to assure compliant and robust manufacturing processes are both developed and/or maintained.
- Responsible and accountable for the timely production of clinical and commercial drug inventory to support Akebia clinical programs and supply for established commercial programs.
- Author, review and approve technical protocols and reports.
- Review and approval of commercial process validation related documentation including validation plans, manufacturing stage specific protocols, and validation reports.
- Employing the principles of Continuous Process Verification (CPV), evaluate and analyze manufacturing data through the use of statistical tools to develop process understanding, establishment of critical process parameters and in-process controls, and the identification of process improvements.
- Hire, mentor and develop a world class drug product organization by identifying experienced candidates and by providing coaching and feedback to all Drug Product personnel.
- Support regulatory submissions by writing/reviewing/approving drug product related sections.
- Bachelor's, Master's, or Ph.D. Degree in Organic Chemistry, Biochemistry, Chemical Engineering or a related discipline.
- 10+ years of relevant experience.
- Experience in pre-formulation characterization of drug substance strongly preferred.
- Experience in developing phase appropriate formulations and drug process manufacturing processes.
- Experience in managing activities at contract development and manufacturing organizations.
- Experience in drafting protocols, technical reports and policies and procedures.
- Ability to review and approve clinical/commercial batch records and extract relevant data for analysis and trending.
- Experience in performing activities supporting registration and validation including but not limited to (preferred): Identification and setting of critical process parameters and in process controls. Identification of additional key process parameters to be monitored. Writing/Reviewing/approving protocols and reports.
- Manufacturing Oversight.
- Ability and desire to work in a fast-paced and dynamic environment.
- Knowledgeable in GMPs and relevant regulatory requirements.
- Demonstrated effective time management skills.
- Sound judgment and commitment to ethical conduct.
- Working knowledge of relevant ICH guidelines, GMPs and global regulatory requirements.
- Strong collaboration, team-building skills and communication skills.
