Jobs at Elektrofi

Join us as Senior Engineer II, Manufacturing Science and Technology, and you’ll be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people’s lives.

• 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

• 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 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.