Scientist, Formulations and Drug Product Manufacturing
5 days 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, Massachusetts, United States Akebia Therapeutics Full timeJob SummaryAkebia Therapeutics is seeking a highly skilled and experienced Senior Formulation Scientist to join our CMC Technical Operations team. 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...
-
Formulation Scientist in Drug Delivery
1 week ago
Cambridge, Massachusetts, United States AcousticaBio Full timeJOB OPPORTUNITY: Scientist, Formulation/Drug Delivery | Advanced Manufacturing in Life ScienceAbout AcousticaBio: We are a pioneering startup at the forefront of advanced manufacturing, dedicated to transforming the landscape of therapeutic delivery. As a venture-backed and NIH-supported entity, we are committed to addressing the complexities associated with...
-
Formulation Scientist in Drug Delivery
1 week ago
Cambridge, Massachusetts, United States AcousticaBio Full timeJOB OPPORTUNITY: Scientist, Formulation/Drug Delivery | Advanced Manufacturing in Life ScienceAbout AcousticaBio: We are a pioneering startup dedicated to transforming the landscape of therapeutic delivery through advanced manufacturing techniques. As a Harvard spin-out supported by venture funding and NIH, we are committed to addressing the complexities...
-
Formulation Scientist in Drug Delivery
1 week ago
Cambridge, Massachusetts, United States AcousticaBio Full timeJOB OPPORTUNITY: Scientist, Formulation/Drug Delivery | Advanced Manufacturing in Life ScienceAbout AcousticaBio: We are a pioneering startup at the forefront of deep-tech innovation, dedicated to transforming the landscape of therapeutic delivery through advanced manufacturing techniques. As a venture and NIH-funded entity emerging from Harvard, we are...
-
Formulation Scientist in Drug Delivery
1 week ago
Cambridge, Massachusetts, United States AcousticaBio Full timeJOB OPPORTUNITY: Scientist, Formulation/Drug Delivery | Advanced Manufacturing in Life ScienceAbout Us: AcousticaBio is a pioneering startup at the forefront of deep-tech innovation, dedicated to transforming the landscape of therapeutic delivery through advanced manufacturing techniques. As a venture-backed entity with a strong foundation from Harvard, we...
-
Associate Formulation Development Scientist
2 months ago
Cambridge, Massachusetts, United States Proclinical Full timeAssociate Formulation Development Scientist - Contract - Cambridge, MAProclinical is seeking a dedicated and innovative individual for the role of Associate Formulation Development Scientist. Primary Responsibilities:The successful candidate will be responsible for the formulation and process development of drug products, with a focus on vials and prefilled...
-
Associate Formulation Development Scientist
2 months ago
Cambridge, United States Proclinical Full timeAssociate Formulation Development Scientist - Contract - Cambridge, MAProclinical is seeking a dedicated and innovative individual for the role of Associate Formulation Development Scientist. Primary Responsibilities:The successful candidate will be responsible for the formulation and process development of drug products, with a focus on vials and prefilled...
-
Cambridge, Massachusetts, United States Akebia Therapeutics Full timeAbout the RoleWe 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...
-
Associate Formulation Development Scientist
2 months ago
Cambridge, United States Proclinical Staffing Full timeAssociate Formulation Development Scientist - Contract - Cambridge, MAProclinical is seeking a dedicated and innovative individual for the role of Associate Formulation Development Scientist. Primary Responsibilities:The successful candidate will be responsible for the formulation and process development of drug products, with a focus on vials and prefilled...
-
Cambridge, Massachusetts, United States Akebia Therapeutics Full timeAbout the RoleWe 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...
-
Formulation Scientist
2 weeks ago
Cambridge, Massachusetts, United States AcousticaBio Full timeJOB OPPORTUNITY: Scientist, Formulation/Drug Delivery | Advanced Manufacturing in Life ScienceAbout Us: AcousticaBio is an innovative deep-tech startup focused on transforming the delivery of groundbreaking therapeutics through advanced manufacturing techniques. As a venture and NIH-funded Harvard spin-out, we are committed to addressing the complexities of...
-
Formulation Scientist
2 weeks ago
Cambridge, Massachusetts, United States AcousticaBio Full timeJOB OPPORTUNITY: Scientist, Formulation/Drug Delivery | Advanced Manufacturing in Life ScienceAbout AcousticaBio: We are a pioneering deep-tech startup committed to transforming the landscape of therapeutic delivery through advanced manufacturing techniques. As a venture and NIH-funded Harvard spin-out, we focus on addressing the complexities associated with...
-
Cambridge, Massachusetts, United States Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Cambridge, United States Editas Medicine Full timeJob DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....
-
Cambridge, United States Editas Medicine Full timeJob DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....
-
Cambridge, United States Editas Medicine Full timeJob DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....
-
Scientist
2 weeks ago
cambridge, United States AcousticaBio Full timeScientist, Formulation/Drug Delivery | Advanced Manufacturing in Life ScienceSummary: AcousticaBio is proud to announce this unique opportunity to join our company as Scientist, Formulation/Drug Delivery. AcousticaBio is an innovative deep-tech startup; we’re a venture and NIH-funded Harvard spin-out and 2021 MassChallenge winner. AcousticaBio is an...
-
Scientist
3 months ago
Cambridge, United States AcousticaBio Full timeScientist, Formulation/Drug Delivery | Advanced Manufacturing in Life ScienceSummary: AcousticaBio is proud to announce this unique opportunity to join our company as Scientist, Formulation/Drug Delivery. AcousticaBio is an innovative deep-tech startup; we’re a venture and NIH-funded Harvard spin-out and 2021 MassChallenge winner. AcousticaBio is an...
