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Principal Engineer, Manufacturing Science And Technology
3 months ago
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 Principal Engineer, Manufacturing Science and Technology to lead technology transfer and continuous process improvements for our patented and proprietary HyperconTM formulation process. This role reports to the SVP, Head of Technical Operations 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 at an Associate Director level and manages 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 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. 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 firms and equipment manufacturers for contracted work involving the construction, commissioning, and IOQ of new HyperconTM formulation suites. Create technology transfer plans, process change control improvements, and CMC support documentation. Lead and own process and manufacturing risk assessments with mitigation action plans. Review and approve 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 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. MINIMUM QUALIFICATIONS B.S. Degree in Engineering/Sciences is required; Advanced M.S./PhD degree in Engineering is a plus consideration. Minimum of 10 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 consideration. 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. 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 #J-18808-Ljbffr
