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 an experienced Associate Director, Manufacturing Science and Technology to lead internal pilot plant manufacturing, technology transfer, and continuous process improvements for our patented and proprietary HyperconTM formulation process. This role reports to the Head of MS&T and will support the company with ongoing operations of an internal pilot plant used to manufacture materials for use in non-human safety studies and other product development investigations. This role will manage a team of 3 to 5 engineers to conduct manufacturing operations to support company goals and partner programs. This role will also play an active part in building future improved pilot plant capabilities to support routine manufacturing for Ph I through commercial. This role manages stakeholders cross-functionally both internally and externally. 

The work for this role is highly matrixed with the complexity of working on several programs in parallel as the company executes the 5-year manufacturing strategy for projected growth. The role will serve as an interface between Program Management, Analytical & Pharmaceutical Development, Quality, Supply Chain, Facilities and Engineering for internal, partner, and CDMO stakeholders. The role will lead cross-functional teams to successfully accomplish goals and objectives, while continuously improving manufacturing supply and process performance. Global travel up to 20% of time may be required during start-up of new manufacturing sites to support technology transfer and batch manufacturing. Lean six sigma methodologies will be leveraged to create, implement, measure, and report on key performance indicators (KPIs) for manufacturing performance. The individual should thrive in a fast-paced and dynamic environment and be a key player in the company’s growth. The individual will join a growing, multidisciplinary team of scientists/engineers and industry professionals. 

KEY RESPONSIBILITIES

· Perform all duties according to the company’s core values, policies, and applicable regulations. 

· As a member of the Technical Operations Team, be a change leader to develop and implement innovative approaches to meet the challenges of the rapidly growing business.

· Accountable for technology transfer execution and routine manufacturing support for bulk aseptic formulation and filling processes from Phase I clinical through commercialization. 

· Manage engineering team to manufacture pilot plant batches and improved capabilities to support Ph I through commercial manufacturing.

· Create operational plans, process change control improvements, and CMC support documentation.

· Lead and own process and manufacturing risk assessments with mitigation action plans.

· Partner closely with stakeholders to ensure internal & external production plans and capacity are aligned with demand needs.

· Partner with PM and IT functions to implement new technologies for data analysis and process monitoring.

 MINIMUM QUALIFICATIONS

· B.S. Degree in Engineering/Sciences is required; Advanced M.S./PhD degree in Engineering is a plus.

· A minimum of 10 years of experience working in a cGMP/cGCP environment is required, preferably working in the biopharmaceutical industry. Preferred experience should be a combination of work experience in Manufacturing, MS&T, Technical Operations, and/or Process Development.

· A minimum of 5 years supporting process technology transfers and new manufacturing site start up is strongly preferred.

· A minimum of 5 years of experience with aseptic bulk formulation and filling processes for biologics including monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), antibody oligonucleotide conjugates (AOCs), vaccines, and/or cell & gene therapies. 

· Having both bulk drug substance and aseptic drug product experiences is a plus.

· Having experience handling organic solvents and microparticle processing is a plus.

· Shown ability to inspire change and build new processes within a diverse and matrix organizational environment is required.

· Advanced manufacturing and technical acumen with ability to influence and direct stakeholder decision-making at senior levels is required.

· Excellent verbal and written communication skills. 

· Strong organizational and customer service-oriented skills.

· Ability to work independently and as part of a team.

· Proficient computer 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 $315 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.

All candidates must be legally authorized to work in the United States  

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