INCOG BioPharma
TSMS – Technical Transfer Engineer
The Technical Services and Manufacturing Sciences (TSMS) Technical Transfer Engineer will be responsible for supporting all facets of Tech transfer, Process Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing (cGMP) for clinical and commercial programs. This role will provide strong technical oversight to the production to ensure robust and reliable production processes are established.
Essential Job Functions
The Technical Transfer Engineer is responsible for autonomously scaling up and transferring process into full scale manufacturing process based on data generated internally or received from the client
Select appropriate equipment and single-use components for GMP manufacturing and develop technical documentation such as Tech Transfer Plan, Gap Assessment, Process Flow Diagram, Summary Reports and Process FMEA
Represents TSMS in project teams and communicates directly with customers. Recognized as Subject Matter Expert for the manufacturing processes
Author GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms
Monitor Process Data, identify trends and propose actions as necessary
Leads technical troubleshooting and investigations of process issues to support root cause analysis, product impact assessment and effective corrective and preventive actions
Provide technical guidance and oversight to Operations and Validation group to support Process Performance Qualification and Continuous Process Verification
Collaborate with cross-functional team to assess and implement new technology for GMP manufacturing
Able to assess impact of changes to the product, process, equipment, procedures and/or materials
Manage timelines and appropriately prioritize critical path tasks to meet deadlines
Other responsibilities as required
Special Job Requirements
Bachelors’ degree in Science or Engineering
Masters’ degree in Science or Engineering preferred
1-3 years of GMP experience required
Experience in Technical Transfer for pharmaceutical or related industry
Additional info about INCOG BioPharma Services At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
By submitting your resume and details, you are declaring that the information is correct and accurate.
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Essential Job Functions
The Technical Transfer Engineer is responsible for autonomously scaling up and transferring process into full scale manufacturing process based on data generated internally or received from the client
Select appropriate equipment and single-use components for GMP manufacturing and develop technical documentation such as Tech Transfer Plan, Gap Assessment, Process Flow Diagram, Summary Reports and Process FMEA
Represents TSMS in project teams and communicates directly with customers. Recognized as Subject Matter Expert for the manufacturing processes
Author GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms
Monitor Process Data, identify trends and propose actions as necessary
Leads technical troubleshooting and investigations of process issues to support root cause analysis, product impact assessment and effective corrective and preventive actions
Provide technical guidance and oversight to Operations and Validation group to support Process Performance Qualification and Continuous Process Verification
Collaborate with cross-functional team to assess and implement new technology for GMP manufacturing
Able to assess impact of changes to the product, process, equipment, procedures and/or materials
Manage timelines and appropriately prioritize critical path tasks to meet deadlines
Other responsibilities as required
Special Job Requirements
Bachelors’ degree in Science or Engineering
Masters’ degree in Science or Engineering preferred
1-3 years of GMP experience required
Experience in Technical Transfer for pharmaceutical or related industry
Additional info about INCOG BioPharma Services At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
By submitting your resume and details, you are declaring that the information is correct and accurate.
#J-18808-Ljbffr