Head Of Manufacturing Science and Technology

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, enthusiastic, and experienced Head of Manufacturing Science and Technology to lead pilot plant manufacturing, technology transfer, and technical life cycle management for our patented and proprietary HyperconTM formulation process. Life cycle management includes pre-clinical pilot scale through Ph I/II/III clinical trials up to commercial launch. This role reports to the SVP, Head of Technical Operations and will support the company with multiple technology transfers and routine manufacturing process support from internal pilot plant to global CDMOs. This role manages stakeholders cross-functionally both internally/externally and directly manages a growing team of 10+ Engineer/Scientists. 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 lead cross-functional teams to successfully accomplish goals and objectives, while continuously improving manufacturing supply and process performance. Global travel up to 50% of time may be required during start-up of new manufacturing sites to support technology transfer and batch manufacturing. A minimum of 3 days per week onsite at corporate headquarters required when not traveling for external manufacturing activities. 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 pre-clinical pilot plant through commercialization.
• Manage internal pilot plant manufacturing team and external manufacturing MS&T team.
• Manage engineering firms and equipment manufacturers for contracted work involving the construction, commissioning, and IOQ of new HyperconTM formulation suites.
• Review and approve aseptic processing and media challenge strategies for new manufacturing processes and sites.
• Establish GLP pilot plant manufacturing operations that scale to Ph I and Ph III/Commercial processes.
• Lead manufacture of pilot plant batches for GLP Toxicology Studies and to support process improvement change management across growing network of manufacturing sites.
• Lead deployment of process improvements and yield optimization initiatives across network of manufacturing sites.
• Lead creation of technology transfer plans, business cases for process improvements, and CMC regulatory documentation.
• Review, approve, and be consultant for validation of CIP/SIP and HyperconTM formulation process.
• Lead and own process and manufacturing risk assessments with mitigation action plans.
• Lead review and approval process for engineering drawings, P&IDs, automation control modules, batch records, process control and validation strategies.
• Work with legal to file IP utility and design patents.
• Partner closely with stakeholders to ensure internal & external production plans and capacity are aligned with clinic 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.
• Own establishment of CPV program and build of process control strategies with cross-functional team.

MINIMUM QUALIFICATIONS

• B.S. and M.S. Degree in Engineering/Sciences is required; Advanced PhD degree in Engineering is a plus consideration.
• A minimum of 15 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, Validation, and/or Development.
• A minimum of 10 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 is required.
• A minimum of 5 years supporting process technology transfers and new manufacturing site start up is required.
• Experience with validation and media challenge qualification is required.
• Experience and expertise for manufacturing bulk aseptic processing and filling operations is required.
• Experience with worldwide regulatory agencies is required.
• 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 and data analysis 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.

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