Director, Technical Quality Operations

DIRECTOR, TECHNICAL QUALITY OPERATIONS

ABOUT ELEKTROFI

Elektrofi is a biopharmaceutical formulation technology company that 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. Formulating the Future of Biologics. www.Elektrofi.com.

POSITION SUMMARY

Elektrofi is seeking a talented and motivated individual to join our biotech company full-time as a Director, Technical Quality Operationsto support the development of the novel Elektrofi formulation platform. The individual will join a growing, multidisciplinary team of scientists/engineers and industry professionals.

A successful candidate will be responsible for supporting all aspects of Technical Quality at Elektrofi including quality oversight of analytical methods development, process development, and internal and external manufacturing of our ultra-high concentration doses at selected Contract Development and Manufacturing Organizations (CDMOs).  We are looking for a candidate with a breadth of professional experience in analytical and process development.

KEY RESPONSIBILITIES

• Responsible for providing Technical Quality support and oversight for analytical methods development, formulation and process development, and manufacturing in support of the Elektrofi proprietary microparticle suspension technology. 
• Working with the head of Quality Systems, define and implement the quality road map for the company through the implementation of appropriate policies and procedures specific to Technical Quality. This includes establishing a clear vision for the implementation of product lifecycle methodologies inclusive of control strategy, change control, and contamination control strategy. 
• Support large scale process implementation at external CDMO, initially Patheon in Milan Italy.
• Primary representative for the Elektrofi Technical Quality with external partners.
• Provide cross-functional support of technology transfers for new processes.
• Provide support and quality oversight of product, process, and component investigations.
• Identify opportunities for process improvements, operational efficiencies, and lead implementation efforts.
• Execute, author, and/or review SOPs, work instructions, and policies as required. 

QUALIFICATIONS

• At a minimum a degree in science or engineering (chemical, biochemical, pharmaceutical mechanical).
• At least 10 years' experience in a quality function with broad experience working with complex biologics.
• Must have direct experience supporting aseptic processes (bulk manufacture, and fill finish) with a clear understanding of EU and US standards for aseptic processing.
• Must have direct experience in analytical method development and method transfer using risk/science-based and phase-appropriate methodology in a cGMP compliant environment.
• Working understanding of complex unit operations, manufacturing systems and processes, and their control systems and how these are reflected in lifecycle documentation is essential.
• Ability to manage multiple projects at times, establish priorities, and meet deadlines to support our client/partner needs.
• Ability to think critically and demonstrate problem-solving skills.
• Ability to demonstrate strong leadership and team building skills.
• Excellent communication and listening skills across all levels Strong written and oral communication skills.

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 $300 per month. Please apply at careers@elektrofi.com.

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.