.. outcomes to management. Participates in special projects and performs other duties as assigned. Licenses and Certifications: Certified as a Wound Ostomy Continence Nurse required Current License and registration to practice as a Registered Professional Nurse in NYS required Education: Bachelor's Degree .. read more
Description:
Responsible to provide direction, strategy, technical leadership, coaching of junior group members, and support for process troubleshooting, process/tech transfers and continuous improvement efforts for a large-scale bio-pharmaceutical manufacturing plant.
Technical lead for at-scale manufacturing for assigned upstream and/or downstream processes of moderate complexity, inclusive of cell culture medium preparation, cell thaw, inoculum expansion, seed stage bioreactors, production bioreactors, and primary harvest with centrifuge and/or filtration, liquid chromatography, column packing, tangential flow and normal flow filtration, bulk formulation, filling, and freezing.
Technical expert and liaison responsible for identification and implementation of at-scale manufacturing technology and improvements to effect positive change to our GMP manufacturing operations.
Independently or collaboratively plan and execute supporting activities, serving as an at-scale technical process SME, working with cross-functional teams and external clients to meet project timelines, quality requirements and to identify/mitigate risks.
Independently or collaboratively leads evaluating process requirements/facility-fit assessments for medium to high complexity projects including identification of materials/quantities and ensuring that processes are consistent with standard manufacturing practices, policies, and regulatory requirements in the large-scale GMP manufacturing facility
Independently or with support from management/Senior SME to author and maintain technical documentation for at-scale processes of higher complexity such as Process Descriptions, Bill of Materials, Campaign Performance Summaries and Presentations, Engineering Run Reports, Engineering Test Protocols, Product/Process Impact Assessments, technical sections of CMC dossiers, BLA Filing, etc.
Responsible for periodic process monitoring/trending and reporting for large-scale manufacturing processes inclusive of designing and developing data repositories and visualizations to monitor, analyze, evaluate, and report process data and trends.
Contribute to the design and planning of small-scale studies in collaboration with Process Sciences for transfer to or, continuous improvement of, at-scale manufacturing.
Skills:
Requires the individual to be able to independently plan, execute and deliver with occasional guidance from their leadership.
Experience working in cross-functional teams in a dynamic, high-pressure environment.
Ability to organize and multi-task in a fast-paced environment.
Experience with biopharmaceutical manufacturing processes, Project Management and Technical Writing.
Experience with upstream and/or downstream bio-pharmaceutical manufacturing.
Knowledge of aseptic processing, and benchtop in-process analytics, buffer preparation and storage for at-scale GMP manufacturing.
Experience with technical writing and BLA filing.
To improve the overall efficiency and integrity of the routine GMP operations must have skills:
Regulatory Filing
Project Management
Communication
Engineering
Must have a strong understanding of fundamental engineering and mathematical concepts pertaining to cell culture, fluid transfer, gas transfer, and mixing.
Possess an excellent mechanical aptitude.
Competency with MS Office Programs.
Good communication skills.
Ability to work in a team setting and as an individual contributor.
Flexible to support a 24/7 GMP production facility.
Hybrid remote/on-site working environment.
Education: Bachelors Degree
Responsible to provide direction, strategy, technical leadership, coaching of junior group members, and support for process troubleshooting, process/tech transfers and continuous improvement efforts for a large-scale bio-pharmaceutical manufacturing plant.
Technical lead for at-scale manufacturing for assigned upstream and/or downstream processes of moderate complexity, inclusive of cell culture medium preparation, cell thaw, inoculum expansion, seed stage bioreactors, production bioreactors, and primary harvest with centrifuge and/or filtration, liquid chromatography, column packing, tangential flow and normal flow filtration, bulk formulation, filling, and freezing.
Technical expert and liaison responsible for identification and implementation of at-scale manufacturing technology and improvements to effect positive change to our GMP manufacturing operations.
Independently or collaboratively plan and execute supporting activities, serving as an at-scale technical process SME, working with cross-functional teams and external clients to meet project timelines, quality requirements and to identify/mitigate risks.
Independently or collaboratively leads evaluating process requirements/facility-fit assessments for medium to high complexity projects including identification of materials/quantities and ensuring that processes are consistent with standard manufacturing practices, policies, and regulatory requirements in the large-scale GMP manufacturing facility
Independently or with support from management/Senior SME to author and maintain technical documentation for at-scale processes of higher complexity such as Process Descriptions, Bill of Materials, Campaign Performance Summaries and Presentations, Engineering Run Reports, Engineering Test Protocols, Product/Process Impact Assessments, technical sections of CMC dossiers, BLA Filing, etc.
Responsible for periodic process monitoring/trending and reporting for large-scale manufacturing processes inclusive of designing and developing data repositories and visualizations to monitor, analyze, evaluate, and report process data and trends.
Contribute to the design and planning of small-scale studies in collaboration with Process Sciences for transfer to or, continuous improvement of, at-scale manufacturing.
Skills:
Requires the individual to be able to independently plan, execute and deliver with occasional guidance from their leadership.
Experience working in cross-functional teams in a dynamic, high-pressure environment.
Ability to organize and multi-task in a fast-paced environment.
Experience with biopharmaceutical manufacturing processes, Project Management and Technical Writing.
Experience with upstream and/or downstream bio-pharmaceutical manufacturing.
Knowledge of aseptic processing, and benchtop in-process analytics, buffer preparation and storage for at-scale GMP manufacturing.
Experience with technical writing and BLA filing.
To improve the overall efficiency and integrity of the routine GMP operations must have skills:
Regulatory Filing
Project Management
Communication
Engineering
Must have a strong understanding of fundamental engineering and mathematical concepts pertaining to cell culture, fluid transfer, gas transfer, and mixing.
Possess an excellent mechanical aptitude.
Competency with MS Office Programs.
Good communication skills.
Ability to work in a team setting and as an individual contributor.
Flexible to support a 24/7 GMP production facility.
Hybrid remote/on-site working environment.
Education: Bachelors Degree