Senior Formulations Scientist

2 months ago

Boston, United States Elektrofi Inc Full time
Job DescriptionJob DescriptionDescription:

ABOUT ELEKTROFI

Elektrofi is revolutionizing the delivery of biologic therapies by giving patients the ability to control how they want to receive and benefit from life-changing medicines. Our breakthrough ultra-high concentration microparticle technology platform resolves the limitations associated with intravenously biologic therapies by enabling convenient at-home subcutaneous self-administration. With a focus on monoclonal antibodies, therapeutic proteins, and other large molecule drugs, we create, develop, and commercialize subcutaneous biologic therapies in collaboration with strategic partners. We believe a patient-centered healthcare approach can lead to a healthier world. We are headquartered in Boston and innovate globally. We are Formulating the Future of BiologicsTM.


POSITION SUMMARY

Elektrofi is seeking talented individuals to join our company full-time as Senior Scientist, Formulation Development to play a key role in the development of Elektrofi’s platform formulation technology. Selected individuals will join a dynamic, multidisciplinary team of scientists and contribute to a variety of IND-enabling formulations activities in a highly collaborative environment.


KEY RESPONSIBILITIES

  • Lead the development of novel, ultra-high concentration, microparticle suspension products with our large biopharmaceutical partners for a wide range of therapeutic biologic modalities using QbD principles.
  • Identify high-leverage opportunities that push the boundaries of the Elektrofi’s formulation platform and improve workflow efficiency to meet critical corporate objectives.
  • Spearhead the development of appropriate scaled-down process models, stress conditions, and experimental methodology to optimize drug product performance along the dimensions of protein stability, dissolution quality, processability, suspension physical stability, and in-vivo performance.
  • Work closely with process development, device, analytical, and translational development teams to identify formulation dependencies on product performance.
  • Act as the subject matter expert on protein stability and formulation. Represent the formulation development function on cross-functional CMC project teams.
  • Author relevant sections in regulatory submissions (IND, DMF, BLA, etc.) and technology transfer documentation. Manage relevant method protocols, data, and reports.
Requirements:

MINIMUM QUALIFICATIONS

  • Ph.D. (0 to 2-year experience) in Pharmaceutical Sciences, Chemical Engineering, Biochemistry, Biophysics, Bioengineering, Medicinal Chemistry, Polymer Chemistry, Pharmaceutical Engineering, or a related field required.
  • Experience with high concentration protein formulation development and UF/DF cycle optimization is desirable.
  • Strong scientific ideation skills and resourcefulness in testing hypotheses.
  • Knowledge of statistical methods and design of experiments methodology.
  • Sharp laboratory acumen and organizational skills.
  • Demonstrated expertise in one or more of the following areas of research is highly desirable:
    • Microparticle processing and particle engineering approaches.
    • Formulation development of protein therapeutics.
    • Strong grasp of pharmacological concepts and a fundamental understanding of drug product development.
    • Ability to work independently and in multi-disciplinary teams.
    • Attention to detail and the ability to thoroughly document experimental work.
    • Familiarity with standard office software (MS Office, Teams, SharePoint, JMP).

Our unique strength lies in transforming pioneering ideas into concrete, life-transforming solutions. To realize this ambitious vision, we are dedicated to nurturing an in-office work ethos. While remote work has its merits, it does not constitute a fundamental aspect of our working approach. As part of our commitment to enhancing the in-office experience, we provide all employees with a commuter assistance program, offering support of up to $315 per month. Please apply at elektrofi.com/careers.


EEOC Statement:

Elektrofi provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.


To all agencies, please, no phone calls or emails to any employee of Elektrofi about this requisition. All resumes submitted by search firms/employment agencies to any employee at Elektrofi via email, the internet, or in any form and method will be deemed the sole property of Elektrofi unless such search firms/employment agencies were engaged by Elektrofi for this requisition and a valid agreement with Elektrofi is in place. If a candidate submitted outside of the Elektrofi agency engagement process is hired, no fee or payment of any kind will be paid.


The candidate must be authorized to work in the US.

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