AbbVie
Scientist I Manufacturing Process Development
AbbVie, Irvine, California, United States, 92713
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at
www.abbvie.com . Follow @abbvie on
Twitter ,
Facebook ,
Instagram ,
YouTube
and
LinkedIn .
Job Description
AbbVie is recruiting for a
Manufacturing Scientist I (Pilot Plant) , Drug Substance Purification Development position in the Department of Neurotoxin & Biologics Process Sciences (NBPS), at its Irvine, CA site.
The Manufacturing Scientist I (Pilot Plant), Drug Substance Purification Development, will be an instrumental team member of the NBPS pilot plant group. The primary roles of this position are to support and execute drug substance purification operations for natural and recombinant proteins (including neurotoxins) from bacterial cultures. Following appropriate guidance, the candidate assembles, tests and inspects for issues, operates during the production process, and ensures all safety procedures are followed.
The desired candidate will have a good understanding of purification concepts and methodology and hands-on work experience with biologics purification process development, including process chromatography, ultrafiltration/diafiltration, depth filtration, centrifugation, etc. Skills with protein precipitation/extraction is desired but not required. The ability to demonstrate a significant level of hands-on experience in purification operations is expected. Additional responsibilities include buffer preparation, equipment maintenance, sample inventory and submission, laboratory organization, biohazard waste decontamination, maintaining detailed records of batches and experiments. The successful candidate will perform laboratory work in a team setting, develop productive collaborations with other groups and be motivated to innovate and succeed in a fast-paced, collaborative environment.
Key Responsibilities:
Operations: Supports and executes BioSafety Level 3 (BSL3) R&D pilot plant activities pertaining to purification process operation: buffer preparation, column packing and testing, chromatography system set up, programming, and operations, ultrafiltration/diafiltration, depth filtration, and process sampling. Ensures the batch record preparation and execution with minimal errors and close out of batch records. Starts and completes manufacturing activities on time, according to the established schedule. In addition to primary responsibilities, desire to operate small lab equipment such as UV spectrophotometer, SDS-PAGE/Western blot, etc. and other hands-on bench work as assigned by scientists.
Must have the ability to multitask. Must work in a team setting with other members of the group and prioritize and allocate time and effort appropriately. Must be able to lift up to 50 lbs.
Technical Support: Provides meaningful assistance with troubleshooting and helps identify solutions to issues that may arise during executions; Supports product development and technology improvement activities including developing and piloting new and innovative operational systems that could be transferred to manufacturing area.
Compliance: Follows established policies, procedures, and practices; Conducts business activities needing minimal deviations or exceptions; Follows established safety requirements, reports incidents/near misses and recommends improvements.
Inventory: Maintain select agent and toxin sample inventory.
Project coordination: Assists in scheduling work tasks, works with the BSL3 pilot plant team and other supporting areas to assure project commitments are met, for example, providing draft batch records for review, assuring material availability, preparing cleaning documentation and completing inventory transactions.
Communication: Reports significant issues to management with appropriate sense of urgency; Attends group and project meetings, being prepared to communicate concerns, and participate in discussions.
Must be willing to work in BSL3 laboratory environment and handle potent neurotoxins and in-process samples that contain neurotoxin and neurotoxin expressing organisms. Learn and develop a safety mindset and adhere to safety procedures regarding neurotoxin handling. Ability to perform all operations and manipulation under a biosafety laminar flow hood.
The scientist must complete training consistent with safety, technical, operational, process, and other skill/ knowledge requirements for the position. Maintain all training to current status. Support safety program and ensure safety in all routine and new operations.
Follow study protocols or batch records and execute experiments independently (or minimal supervision) at small and large scales.
Author and edit development batch records and associated standard operating procedures.
Assist the team in maintaining laboratory equipment, supply inventory, and organization.
Qualifications
BS in Biochemistry, Chemistry, Pharmaceutical Sciences, Biochemical/Chemical Engineering, or closely related field with 5+ years of experience or MS in the above field plus 2+ years of experience in manufacturing operation or R&D area in pharmaceutical/biotechnology industry.
Hands-on experience in purification operations, including chromatography and ultrafiltration/diafiltration.
Must have a team-centric mindset to integrate seamlessly in a team setting when working/collaborating with other members within the group and with other groups.
Support safety program and ensure safety in all routine and new operations by strictly following SOPs.
Continuous improvement mindset.
#J-18808-Ljbffr
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at
www.abbvie.com . Follow @abbvie on
Twitter ,
Facebook ,
Instagram ,
YouTube
and
LinkedIn .
Job Description
AbbVie is recruiting for a
Manufacturing Scientist I (Pilot Plant) , Drug Substance Purification Development position in the Department of Neurotoxin & Biologics Process Sciences (NBPS), at its Irvine, CA site.
The Manufacturing Scientist I (Pilot Plant), Drug Substance Purification Development, will be an instrumental team member of the NBPS pilot plant group. The primary roles of this position are to support and execute drug substance purification operations for natural and recombinant proteins (including neurotoxins) from bacterial cultures. Following appropriate guidance, the candidate assembles, tests and inspects for issues, operates during the production process, and ensures all safety procedures are followed.
The desired candidate will have a good understanding of purification concepts and methodology and hands-on work experience with biologics purification process development, including process chromatography, ultrafiltration/diafiltration, depth filtration, centrifugation, etc. Skills with protein precipitation/extraction is desired but not required. The ability to demonstrate a significant level of hands-on experience in purification operations is expected. Additional responsibilities include buffer preparation, equipment maintenance, sample inventory and submission, laboratory organization, biohazard waste decontamination, maintaining detailed records of batches and experiments. The successful candidate will perform laboratory work in a team setting, develop productive collaborations with other groups and be motivated to innovate and succeed in a fast-paced, collaborative environment.
Key Responsibilities:
Operations: Supports and executes BioSafety Level 3 (BSL3) R&D pilot plant activities pertaining to purification process operation: buffer preparation, column packing and testing, chromatography system set up, programming, and operations, ultrafiltration/diafiltration, depth filtration, and process sampling. Ensures the batch record preparation and execution with minimal errors and close out of batch records. Starts and completes manufacturing activities on time, according to the established schedule. In addition to primary responsibilities, desire to operate small lab equipment such as UV spectrophotometer, SDS-PAGE/Western blot, etc. and other hands-on bench work as assigned by scientists.
Must have the ability to multitask. Must work in a team setting with other members of the group and prioritize and allocate time and effort appropriately. Must be able to lift up to 50 lbs.
Technical Support: Provides meaningful assistance with troubleshooting and helps identify solutions to issues that may arise during executions; Supports product development and technology improvement activities including developing and piloting new and innovative operational systems that could be transferred to manufacturing area.
Compliance: Follows established policies, procedures, and practices; Conducts business activities needing minimal deviations or exceptions; Follows established safety requirements, reports incidents/near misses and recommends improvements.
Inventory: Maintain select agent and toxin sample inventory.
Project coordination: Assists in scheduling work tasks, works with the BSL3 pilot plant team and other supporting areas to assure project commitments are met, for example, providing draft batch records for review, assuring material availability, preparing cleaning documentation and completing inventory transactions.
Communication: Reports significant issues to management with appropriate sense of urgency; Attends group and project meetings, being prepared to communicate concerns, and participate in discussions.
Must be willing to work in BSL3 laboratory environment and handle potent neurotoxins and in-process samples that contain neurotoxin and neurotoxin expressing organisms. Learn and develop a safety mindset and adhere to safety procedures regarding neurotoxin handling. Ability to perform all operations and manipulation under a biosafety laminar flow hood.
The scientist must complete training consistent with safety, technical, operational, process, and other skill/ knowledge requirements for the position. Maintain all training to current status. Support safety program and ensure safety in all routine and new operations.
Follow study protocols or batch records and execute experiments independently (or minimal supervision) at small and large scales.
Author and edit development batch records and associated standard operating procedures.
Assist the team in maintaining laboratory equipment, supply inventory, and organization.
Qualifications
BS in Biochemistry, Chemistry, Pharmaceutical Sciences, Biochemical/Chemical Engineering, or closely related field with 5+ years of experience or MS in the above field plus 2+ years of experience in manufacturing operation or R&D area in pharmaceutical/biotechnology industry.
Hands-on experience in purification operations, including chromatography and ultrafiltration/diafiltration.
Must have a team-centric mindset to integrate seamlessly in a team setting when working/collaborating with other members within the group and with other groups.
Support safety program and ensure safety in all routine and new operations by strictly following SOPs.
Continuous improvement mindset.
#J-18808-Ljbffr