Elektrofi
Senior Engineer II, Manufacturing Science and Technology
Elektrofi, Boston, Massachusetts, us, 02298
Senior Engineer II, Manufacturing Science and Technology
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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 Hypercon 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.
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 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.
Additional Information Elektrofi’s approach emphasizes in-office collaboration. To realize our vision, we value a team-based working environment. Please apply at elektrofi.com/careers.
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 US.
Job Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Engineering and Information Technology
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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 Hypercon 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.
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 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.
Additional Information Elektrofi’s approach emphasizes in-office collaboration. To realize our vision, we value a team-based working environment. Please apply at elektrofi.com/careers.
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 US.
Job Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Engineering and Information Technology
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