Senior Research Associate, Formulation Development

Description

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 a motivated individual to join our biotech company as a Senior Research Associate, Formulation Development to support the development of the novel Elektrofi formulation platform. The individual will join a growing, multidisciplinary team of scientists/engineers and industry professionals.

KEY RESPONSIBILITIES

• Support the early phase development of novel, ultra-high concentration, microparticle suspension products with our biopharmaceutical partners.
• Contribute to formulation development activities for clinical formulations for a wide range of therapeutic biologic modalities using QbD principles.
• Utilize scaled-down process models and stress conditions to select formulations that optimize drug product performance, including protein stability and suspension physical properties
• Exercise technical discretion in day-to-day laboratory activities.
• Collaborate with analytical development team to define and characterize drug product physicochemical and biochemical properties.
• Manage, compile and analyze data using analytical software.
• Contribute to continuous improvement of systems and processes to improve workflow efficiency.
• Represent the formulation development function on cross-functional CMC project and initiative teams.

Manage relevant method protocols, present findings and author reports to support regulatory submissions (IND, IMPD, BLA, etc.) and technology transfer documentation

Requirements

MINIMUM QUALIFICATIONS

• Masters with 2+ years experience in Pharmaceutical Sciences, Chemical Engineering, Biochemistry, Bioengineering, Polymer Chemistry, Pharmaceutical Engineering, or a related field; or Bachelors with 4+ years experience in related field.
• Demonstrated experience developing and optimizing protein formulations.
• Knowledge of protein formulations and degradation mechanisms.
• Knowledge of statistical methods and design of experiments methodology.
• Familiarity with standard office software (MS Office, Teams, SharePoint, JMP) and electronic laboratory notebooks.
• Demonstrated good laboratory skills, organizational skills, and attention to detail.
• Ability to work in multi-disciplinary teams.
• Demonstrated experience in one or more of the following areas of research is highly desirable:

o Experience with high concentration protein formulation, small molecule injectables, or lyophilized product development.

o Experience with primary container selection, including compatibility and container closure integrity evaluations

o Experience with development of pre-filled syringes and other combination products.

o Experience with dosing compatibility studies

o Optimization of UF/DF processing of antibodies.

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. Please apply at ....

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.

All candidates must be legally authorized to work in the US.

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