Lead Engineer, Manufacturing Science and Technology

2 weeks ago

Boston, Massachusetts, United States Elektrofi Inc Full time
Position Overview

ABOUT ELEKTROFI INC

Elektrofi Inc is at the forefront of transforming the administration of biologic therapies, empowering patients with the flexibility to choose how they receive essential medications. Our innovative ultra-high concentration microparticle technology addresses the challenges linked to traditional intravenous biologic therapies, facilitating convenient at-home subcutaneous self-administration. We specialize in monoclonal antibodies, therapeutic proteins, and other large molecule drugs, collaborating with strategic partners to develop and commercialize subcutaneous biologic therapies. Our mission is to enhance patient-centered healthcare, contributing to a healthier global community.

ROLE SUMMARY

We are in search of a skilled and passionate Lead Engineer, Manufacturing Science and Technology to spearhead technology transfer initiatives and drive continuous enhancements in our proprietary HyperconTM formulation process. This position reports directly to the Senior Vice President of Technical Operations and plays a crucial role in supporting multiple technology transfers and routine manufacturing processes at global contract development and manufacturing organizations (CDMOs) and partner sites. Operating at an Associate Director level, this role requires effective management of cross-functional stakeholders both internally and externally. The complexity of this position involves overseeing several concurrent technology transfer programs as we implement our strategic manufacturing plan for anticipated growth. The Lead Engineer will act as a liaison among Program Management, Analytical & Process Development, Quality Assurance, Supply Chain, Engineering, and Manufacturing teams for both internal and external stakeholders. This role will lead cross-functional teams to achieve objectives while continuously enhancing manufacturing supply and process efficiency. Occasional global travel may be necessary to support technology transfer and batch manufacturing during the initiation of new manufacturing sites. Lean Six Sigma methodologies will be utilized to establish, implement, measure, and report on key performance indicators (KPIs) related to manufacturing performance. The ideal candidate will thrive in a dynamic, fast-paced environment and be a pivotal contributor to the company's expansion. You will join a diverse and growing team of scientists, engineers, and industry experts.

KEY RESPONSIBILITIES

  • Execute all responsibilities in alignment with the company's core values, policies, and relevant regulations.
  • As a member of the Technical Operations Team, lead change initiatives to develop and implement innovative solutions to meet the demands of our rapidly expanding business.
  • Oversee technology transfer execution and provide routine manufacturing support for bulk aseptic formulation and filling processes from early clinical phases through to commercialization.
  • Manage relationships with engineering firms and equipment manufacturers for contracted projects involving the construction, commissioning, and installation qualification of new HyperconTM formulation suites.
  • Develop technology transfer plans, process change control enhancements, and CMC support documentation.
  • Lead and conduct process and manufacturing risk assessments, including the formulation of mitigation strategies.
  • Review and approve engineering schematics, P&IDs, automation control systems, batch records, and validation strategies.
  • Collaborate closely with stakeholders to ensure alignment of internal and external production plans with clinical demand.
  • Support the manufacturing network during regulatory inspections of sites.
  • Work with Project Management and IT teams to implement new technologies for data analysis and process monitoring.

MINIMUM QUALIFICATIONS

  • Bachelor's Degree in Engineering or Sciences is required; an advanced degree (M.S./PhD) in Engineering is preferred.
  • A minimum of 10 years of experience in a cGMP/cGCP environment is required, ideally within the biopharmaceutical sector, focusing on biologics or cell & gene therapy. A combination of experience in Manufacturing, MS&T, Technical Operations, and/or Development is preferred.
  • At least 5 years of experience in supporting process technology transfers and initiating new manufacturing sites is strongly preferred.
  • A minimum of 5 years of experience with aseptic bulk formulation and filling processes for monoclonal antibodies, antibody-drug conjugates, and/or cell & gene therapies is required.
  • Experience with both bulk drug substance and aseptic drug product processes is a plus.
  • Demonstrated ability to inspire change and establish new processes within a diverse and matrixed organizational structure is essential.
  • Advanced technical and manufacturing knowledge with the capacity to influence and guide decision-making among senior stakeholders is required.
  • Exceptional verbal and written communication skills.
  • Strong organizational skills and a customer service-oriented mindset.
  • Ability to work independently as well as collaboratively within a team.
  • Proficient in computer applications.

Our strength lies in converting innovative ideas into tangible, life-changing solutions. We are committed to fostering an in-office work culture, as we believe it enhances collaboration and creativity. We offer a commuter assistance program to support our employees.

EEOC Statement:

Elektrofi Inc is an equal opportunity employer, providing fair employment opportunities to all employees and applicants, and prohibits discrimination and harassment of any kind based on 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.

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

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