Scientist- Drug Product Innovation

Job Description

Job Description

Description : ABOUT ELEKTROFI

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 talented and motivated individual to join our company full-time as a Scientist / Lead Engineer, Drug Product Innovation to play a key role in the development of Elektrofi’s platform formulation technology and innovation strategy.

Selected individuals will join a dynamic, multidisciplinary team of scientists and contribute to a variety of innovative platform expansion activities in a highly collaborative environment.

KEY RESPONSIBILITIES

• Lead the development of novel, ultra-high concentration, microparticle suspension products for a wide range of therapeutic biologic modalities using QbD principles.
• Become an expert on the fundamental physicochemical characteristics of our microparticle suspension formulations to define drug product CQAs and to enable exploration of platform expansion opportunities through proof-of-concept experimentation.
• Work with Patent Counsel to strengthen and expand Elektrofi’s patent portfolio.
• Lead program-specific container closure and device-related activities and collaborate with external biotech and pharma partners.
• Represent Drug Product Innovation on cross-functional teams and initiatives.
• Anticipate and develop scientifically robust risk mitigation strategies for process and product.
• Help author relevant sections in regulatory submissions (IND, DMF, BLA, etc.) and technology transfer documentation. Manage relevant method protocols, data, and reports.

Requirements :

MINIMUM QUALIFICATIONS

• A background in Chemical, Biomedical, Pharmaceutical, Materials Engineering, or Colloids Science.
• Master’s with 4+ years experience or Ph.D. (preferred).
• Strong analytical and critical thinking abilities.
• Excellent verbal and written communication skills.
• Hands on (wet) laboratory experience with biopharmaceutical process equipment, parenteral delivery devices, analysis of biologic drug products, microparticle / suspension analytical tools, and rheology.
• A detail-oriented approach to documenting experiments.
• The ability to work independently and in multi-disciplinary teams efficiently in a fast-paced R&D environment.
• General knowledge of cGMP, GLP, and regulatory requirements for biotech and pharmaceutical industries is highly desirable.
• Demonstration of innovative thinking and creativity in science / engineering.
• Familiarity with computer programming languages and standard office software (MS Office).
• Good attention to detail and the ability to thoroughly document experimental work.

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 [email protected].

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.