Scientist, Formulations and Drug Product Manufacturing
3 months ago
A Third Rock Ventures Stealth NewCo is seeking a Formulations Scientist and Drug Product Lead who is interested in establishing core operations of a new team. This position will be a laboratory-based role and will offer tremendous 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 creative and imaginative problem-solving skills to help bring new products to patients.
RESPONBILITIES
- Work collaboratively with discovery, non-clinical, clinical, and CMC teams to develop and deliver phase-appropriate materials for animal and clinical studies.
- Develop robust formulations for novel protein therapeutics and dosage forms for early/late-stage development.
- Establish an internal formulation development laboratory with analytical capabilities and execute studies (formulations screening, DP in-use/compatibility, etc.) for drug candidates.
- Manage contracted manufacturing organizations (CMOs) to scale-up formulations and to support DP technology transfer activities and DP deviations/investigations as needed.
- Author technical development reports and author/review relevant sections of regulatory filings such as IND, IMPD, etc.
EDUCATION REQUIREMENTS AND QUALIFICATIONS:
- Ph.D. in Pharmaceutics, Material Sciences, Engineering or related discipline with a minimum 2+ years industry experience (or MS with 5+ years or BS with 8+ years) developing formulations.
- Hands-on experience developing formulations and manufacturing processes using Quality-by-Design (QbD) principles for various dosage forms, to meet phase appropriate requirements of the drug product.
- Experience with Biologics, high concentration formulation development, SEC, CE-SDS, cIEF, biophysical characterization, and sub-visible particle measurements required. Experience with Fc-fusion molecules or similar complex biologics molecules is a plus.
- A good working knowledge of designing efficient experiments (DOE) and statistical techniques for data analysis.
- Goal oriented team player with excellent communication skills, flexibility, and ability to work in a fast-paced environment with multiple teams across the company.
- Experience with device development is a plus.
-
Cambridge, United States Third Rock Ventures Full timeA Third Rock Ventures Stealth NewCo is seeking a Formulations Scientist and Drug Product Lead who is interested in establishing core operations of a new team. This position will be a laboratory-based role and will offer tremendous opportunities to advance programs, develop new workflows, implement devices, and build a laboratory. Successful candidates will...
-
cambridge, United States Third Rock Ventures Full timeA Third Rock Ventures Stealth NewCo is seeking a Formulations Scientist and Drug Product Lead who is interested in establishing core operations of a new team. This position will be a laboratory-based role and will offer tremendous opportunities to advance programs, develop new workflows, implement devices, and build a laboratory. Successful candidates will...
-
Cambridge, United States Third Rock Ventures Full timeA Third Rock Ventures Stealth NewCo is seeking a Formulations Scientist/ Senior Scientist and Drug Product Lead who is interested in establishing core operations of a new team. This position will be a laboratory-based role and will offer tremendous opportunities to advance programs, develop new workflows, implement devices, and build a laboratory. Successful...
-
Cambridge, MA, United States Third Rock Ventures Full timeA Third Rock Ventures Stealth NewCo is seeking a Formulations Scientist and Drug Product Lead who is interested in establishing core operations of a new team. This position will be a laboratory-based role and will offer tremendous opportunities to advance programs, develop new workflows, implement devices, and build a laboratory. Successful candidates will...
-
cambridge, United States Third Rock Ventures Full timeA Third Rock Ventures Stealth NewCo is seeking a Formulations Scientist/ Senior Scientist and Drug Product Lead who is interested in establishing core operations of a new team. This position will be a laboratory-based role and will offer tremendous opportunities to advance programs, develop new workflows, implement devices, and build a laboratory. Successful...
-
Cambridge, Massachusetts, United States Editas Medicine Full timeAt Editas Medicine, we're at the forefront of pioneering innovative gene editing technologies to transform the future of medicine. Our mission is to harness the power and potential of CRISPR/Cas12a and CRISPR/Cas9 genome editing systems to develop transformative, durable, precision genomic medicines for people living with serious diseases worldwide.We're...
-
Senior Formulation Development Scientist
7 days ago
Cambridge, Massachusetts, United States Flagship Ventures Full timeAbout the RoleWe are seeking an experienced Senior Formulation Development Scientist to lead our LNP formulation development efforts. This is a highly skilled and motivated role that will involve designing and developing advanced LNP formulations for pre-clinical stage programs.Key ResponsibilitiesDesign, develop, and optimize LNP formulations for nucleic...
-
Cambridge, Massachusetts, United States AbbVie Full timeAbout the RoleWe are seeking a highly motivated Senior Scientist to join our team in Cambridge, MA. As a key member of our preclinical development group, you will be responsible for providing formulation support for initial safety and efficacy assessments.ResponsibilitiesCharacterize the physicochemical properties of candidate molecules in preclinical...
-
Senior LNP Formulation Lead
7 days ago
Cambridge, Massachusetts, United States Flagship Ventures Full timeCompany Overview: Mirai Bio is a biotechnology company transforming the approach to information molecule therapeutics. The company has made significant progress in treating undruggable diseases and designing therapies with unprecedented turnaround times. Our platform integrates nanoparticle development with informatics technologies and experimentation to...
-
Research Scientist
7 days ago
Cambridge, Massachusetts, United States Massachusetts Institute of Technology Full timeThe Massachusetts Institute of Technology is seeking a highly skilled Research Scientist to join their team in the field of mechanical engineering.As a Research Scientist, you will have the opportunity to design drug delivery devices for clinically-relevant solutions to gastrointestinal drug delivery systems. You will be responsible for performing rapid...
-
Cambridge, Massachusetts, United States Editas Medicine Full timeTransformative Medicine at EditasWe are pioneering the possible with CRISPR/Cas12a and CRISPR/Cas9 genome editing systems. Our mission is to develop durable, precision genomic medicines for people living with serious diseases worldwide.Why Choose Editas?We're a team of courageous problem solvers harnessing the power of CRISPR gene editing to transform...
-
Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full timeJob OverviewThis role is responsible for leading the formulation development of oral dosage forms for clinical trials and potential market release.The successful candidate will act as a primary technical expert and manage external partnerships for drug product development.Primary Job ResponsibilitiesSpearhead scientific strategy in formulation aligned with...
-
AD/Director of External Manufacturing
4 months ago
Cambridge, United States QurAlis Full timePosition Overview:The AD/Director of Small Molecule External Manufacturing at QurAlis plays a pivotal role in supporting the development and optimization of chemical processes for small molecule production and overseeing the refinement of external manufacturing processes for Active Pharmaceutical Ingredients (API), drug products, and primary packaging. As a...
-
AD/Director of External Manufacturing
3 months ago
cambridge, United States QurAlis Full timePosition Overview:The AD/Director of Small Molecule External Manufacturing at QurAlis plays a pivotal role in supporting the development and optimization of chemical processes for small molecule production and overseeing the refinement of external manufacturing processes for Active Pharmaceutical Ingredients (API), drug products, and primary packaging. As a...
-
AD/Director of External Manufacturing
3 months ago
cambridge, United States QurAlis Full timePosition Overview:The AD/Director of Small Molecule External Manufacturing at QurAlis plays a pivotal role in supporting the development and optimization of chemical processes for small molecule production and overseeing the refinement of external manufacturing processes for Active Pharmaceutical Ingredients (API), drug products, and primary packaging. As a...
-
AD/Director of External Manufacturing
2 months ago
Cambridge, United States QurAlis Full timePosition Overview:The AD/Director of Small Molecule External Manufacturing at QurAlis plays a pivotal role in supporting the development and optimization of chemical processes for small molecule production and overseeing the refinement of external manufacturing processes for Active Pharmaceutical Ingredients (API), drug products, and primary packaging. As a...
-
Scientist, Analytical Development
5 days ago
Cambridge, United States Thymmune Therapeutics Full timeAbout UsThymmune Therapeutics is a cutting-edge biotechnology company focused on advancing innovative immunotherapies to treat a variety of diseases. Our mission is to harness the power of thymic epithelial cells (TECs) derived from induced pluripotent stem cells (iPSCs) to develop novel immune-based therapies. As we grow and expand our capabilities, we are...
-
Associate Director, Combination Product
4 weeks ago
Cambridge, United States Scholar Rock Full timeScholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGF?) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the...
-
Scientific Researcher
2 days ago
Cambridge, Massachusetts, United States Eli Lilly Full timeAbout the RoleAt Eli Lilly, we are committed to improving human life through medical innovation. As a Principal Scientist, you will play a critical role in formulating and characterizing novel nucleic acid delivery constructs.ResponsibilitiesEvaluate nucleic acid delivery constructs and optimize related protocols.Troubleshoot experimental issues and...
-
cambridge, United States Thymmune Therapeutics Full timeAbout UsThymmune Therapeutics is a cutting-edge biotechnology company focused on advancing innovative immunotherapies to treat a variety of diseases. Our mission is to harness the power of thymic epithelial cells (TECs) derived from induced pluripotent stem cells (iPSCs) to develop novel immune-based therapies. As we grow and expand our capabilities, we are...
