Senior Engineer II, Manufacturing Science and Technology

Job Type

Full-time

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 administered biologic therapies by enabling convenient at-home subcutaneous self-administration. With a focus on monoclonal antibodies, therapeutic proteins, and other biologics, we partner with companies to develop and commercialize our novel Hypercon formulations. 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 Biologics.

Position Summary
Elektrofi is seeking a talented, enthusiastic, and experienced Senior Engineer II, Manufacturing Science and Technology to execute technology transfer and continuous process improvements for our patented and proprietary HyperconTM formulation process. This role reports to the Sr. Director, Manufacturing Science & Technology and will support the company with multiple technology transfers and routine manufacturing process support at global CDMOs and business partner manufacturing sites. This role operates will manage stakeholders cross-functionally both internally and externally. The work for this role is highly matrixed with the complexity of working on several technology transfer 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 & Process Development, Quality, Supply Chain, Engineering, and Manufacturing for internal, partner, and CDMO stakeholders. The role will participate in cross-functional teams to successfully accomplish goals and objectives, while continuously improving manufacturing supply and process performance. Global travel up to 25% 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 MS&T Team, be a change leader to develop and implement innovative approaches to meet the challenges of the rapidly growing business.
• Responsible for technology transfer execution and routine manufacturing support for bulk aseptic formulation and filling processes from Phase I clinical through commercialization.
• Create technology transfer plans, campaign summary reports, process change documentation to support change controls, and CMC support documentation.
• Lead and own process and manufacturing risk assessments with mitigation action plans.
• Review engineering drawings, P&IDs, automation control modules, batch records, process control and validation strategies.
• Partner closely with stakeholders to ensure internal & external production plans and capacity are aligned with clinical demand needs.
• Support manufacturing network during regulatory site inspections.
• Partner with PM and IT functions to implement new technologies for data analysis and process monitoring

Requirements
MINIMUM QUALIFICATIONS

• B.S. Degree in Engineering/Sciences is required; Advanced M.S./PhD degree in Engineering is a plus consideration.
• Minimum of 8 years of experience working in a cGMP/cGCP environment is required, preferably working in biologics or cell & gene therapy within the biopharmaceutical industry. Preferred experience should be a combination of work experience in Manufacturing, MS&T, Technical Operations, and/or Development.
• Minimum of 5 years supporting process technology transfers and new manufacturing site start up is strongly preferred.
• Minimum of 5 years of experience with aseptic bulk formulation and filling processes for 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.
• 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. 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.
Salary Description

$130,000-$165,000