Engineering - Senior Associate Scientist - TechDigital
Devens, MA
About the Job
The Senior Scientist Person in Plant (PIP) is considered the primary MS&T representative at the external manufacturing facility and works from our Devens, MA location.
This position is responsible for providing technical support to commercial operations in addition to ensuring delivery of technical transfer activities. The position will be responsible for monitoring daily activities at our external manufacturing organization, interfacing with technical, quality and manufacturing representatives at site. This position will support all MS&T related activities at the CMO site and forms part of the MS&T external manufacturing team.
Responsibilities:
Responsible for supporting commercial manufacturing performance at the external manufacturing site. Represents MS&T external manufacturing team to provide person in plant technical support to the commercial manufacturing process including deviation resolution, change management, delivery of yield targets and optimization.
Maintains strong working relationships with external partner(s).
Interface with internal Client functions such as MS&T, Quality, supplier Change Manager and Supply Chain.
Develop and maintain strong technical familiarity with process and process equipment, process optimization evolution and technical problem solving.
Tracks progress of routine manufacturing and tech transfer projects against schedule, provides routine updates and proactively identifies operational risks and remediation.
Ensures timely escalation of potential technical, compliance or safety issues to the SRM/MS&T team and partners with internal MS&T resources to remediate.
Ensures effective communication between technical and quality representatives at the contract manufacturing sire, including other PIP team members.
Lead/support technology transfer activities as applicable.
Implement and maintain high standard of quality and regulatory compliance to meet and exceed regulatory agency and quality requirements.
Expectation to travel to Syracuse once a month--20 to 30% of time would be required to travel to this site
Required Experience and Education:
Education: Bachelor's Degree Required--Master's Degree is Desired
Science or engineering degree in biotechnology, biochemical or related discipline.
Experience in drug substance manufacturing essential to the role.
A strong practical knowledge of the technologies related to mammalian cell culture, therapeutic protein purification and process engineering.
Demonstrated ability to work independently and prioritize activities
A proven ability to work on complex problems in which analysis of situations/data requires an in-depth evaluation of multiple factors is essential
Experience in technology transfer of processes for commercial manufacture and associated regulatory requirements
Ability to work in a multi-disciplinary team, partner with various functions to provide strong leadership to drive risk-based decisions
Demonstrated ability in technical writing, computer-based knowledge and communication skills
Top 5 Measurable skills and experiences a candidate must have to be successful in this role:
+3 years of experience with a strong practical knowledge of the technologies related to mammalian cell culture, therapeutic protein purification and process engineering.
Demonstrated ability to work independently and prioritize activities
A proven ability to work on complex problems in which analysis of situations/data requires an in-depth evaluation of multiple factors is essential
Experience in technology transfer of processes for commercial manufacture and associated regulatory requirements
Ability to work in a multi-disciplinary team, partner with various functions to provide strong leadership to drive risk-based decisions
Demonstrated ability in technical writing, computer-based knowledge and communication skills
This position is responsible for providing technical support to commercial operations in addition to ensuring delivery of technical transfer activities. The position will be responsible for monitoring daily activities at our external manufacturing organization, interfacing with technical, quality and manufacturing representatives at site. This position will support all MS&T related activities at the CMO site and forms part of the MS&T external manufacturing team.
Responsibilities:
Responsible for supporting commercial manufacturing performance at the external manufacturing site. Represents MS&T external manufacturing team to provide person in plant technical support to the commercial manufacturing process including deviation resolution, change management, delivery of yield targets and optimization.
Maintains strong working relationships with external partner(s).
Interface with internal Client functions such as MS&T, Quality, supplier Change Manager and Supply Chain.
Develop and maintain strong technical familiarity with process and process equipment, process optimization evolution and technical problem solving.
Tracks progress of routine manufacturing and tech transfer projects against schedule, provides routine updates and proactively identifies operational risks and remediation.
Ensures timely escalation of potential technical, compliance or safety issues to the SRM/MS&T team and partners with internal MS&T resources to remediate.
Ensures effective communication between technical and quality representatives at the contract manufacturing sire, including other PIP team members.
Lead/support technology transfer activities as applicable.
Implement and maintain high standard of quality and regulatory compliance to meet and exceed regulatory agency and quality requirements.
Expectation to travel to Syracuse once a month--20 to 30% of time would be required to travel to this site
Required Experience and Education:
Education: Bachelor's Degree Required--Master's Degree is Desired
Science or engineering degree in biotechnology, biochemical or related discipline.
Experience in drug substance manufacturing essential to the role.
A strong practical knowledge of the technologies related to mammalian cell culture, therapeutic protein purification and process engineering.
Demonstrated ability to work independently and prioritize activities
A proven ability to work on complex problems in which analysis of situations/data requires an in-depth evaluation of multiple factors is essential
Experience in technology transfer of processes for commercial manufacture and associated regulatory requirements
Ability to work in a multi-disciplinary team, partner with various functions to provide strong leadership to drive risk-based decisions
Demonstrated ability in technical writing, computer-based knowledge and communication skills
Top 5 Measurable skills and experiences a candidate must have to be successful in this role:
+3 years of experience with a strong practical knowledge of the technologies related to mammalian cell culture, therapeutic protein purification and process engineering.
Demonstrated ability to work independently and prioritize activities
A proven ability to work on complex problems in which analysis of situations/data requires an in-depth evaluation of multiple factors is essential
Experience in technology transfer of processes for commercial manufacture and associated regulatory requirements
Ability to work in a multi-disciplinary team, partner with various functions to provide strong leadership to drive risk-based decisions
Demonstrated ability in technical writing, computer-based knowledge and communication skills
Source : TechDigital