BioSpace
Engineer/Scientist - Technical Services/Manufacturing Science (2nd Shift)
BioSpace, Branchburg Township, New Jersey, United States
Engineer/Scientist - Technical Services/Manufacturing Science (2nd Shift)
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Engineer/Scientist - Technical Services/Manufacturing Science (2nd Shift)
role at
BioSpace
Organization Overview This position is responsible for second shift technical support of manufacturing operations. It will interact with engineering, manufacturing, validation, quality assurance, quality control and regulatory departments. Interaction may be required with other Lilly site/contract producers of Lilly products. Knowledge of cell culture, purification and support systems used in the manufacturing of biotech products is required. Support hours are four days on – four days off from approximately 12:00 pm to 12:30 am.
Responsibilities
Monitors (trends) and analyzes production data. Applies process knowledge and data analysis skills to support the management of daily manufacturing operations. Drives solutions for products and processes.
Troubleshoots issues in conjunction with Process Teams and/or manufacturing staff on the manufacturing floor. Anticipates and resolves problems. Communicates issues in a timely manner. Assists during process‑related investigations and assesses technical impact. Serves as a key resource within a TS/MS area or discipline. Gains support for ideas or positions on difficult issues.
Assists in the transfer of processes from process development to production facilities and from one production facility to another, anticipating and addressing scale‑up issues.
Authors technical reports supporting process control strategies, technology transfers, deviation observations, process monitoring/analyses, and technical studies.
Writes standard operating procedures as they relate to the activities of the TS/MS group. Authors or revises manufacturing procedures and batch records as necessary to enable precise execution and ensure practice matches procedure. Reviews and approves manufacturing batch records and other manufacturing documentation.
Works directly with the Manufacturing staff on the manufacturing floor to share process knowledge. Assists in process‑related training of Manufacturing Process Team members. As required, directly gathers additional supporting data on the manufacturing floor.
As required, designs laboratory experiments in support of process troubleshooting and/or continuous improvement and executes or coordinates execution in outside laboratories. Helps to define and implement continuous improvements and change controls to manufacturing processes.
Works with Manufacturing to support the start‑up and validation of new facilities and the associated process equipment. Helps to implement control strategies for Lilly Branchburg processes.
As required, may lead or assist in the planning and execution of process validation activities.
Understands, and performs all job responsibilities in compliance with safety and regulatory expectations as well as cGMP.
Basic Requirements
BS degree in Chemistry, Microbiology, Biochemistry or related science, or BS in Chemical Engineering or related engineering discipline.
Position is a banded position and years of experience in a cGMP biopharmaceutical or pharmaceutical manufacturing and/or development environment will be considered in initial placement within the band.
Excellent communication skills, both oral and written.
Additional Skills/Preferences
Experience in fermentation/cell culture and/or protein purification manufacturing.
Process and equipment knowledge of cell culture or purification functions.
Thorough understanding of GMP requirements for a large scale manufacturing facility.
Demonstrated leadership skills.
Additional Information Travel:
Shift: Support hours are approximately 2 PM – 10 PM Wednesday, 2 PM – 12 AM Thursday, 2 PM – 12 AM Friday, 12 PM – 12 AM Saturday.
Compensation Actual compensation will depend on candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $72,000 – $189,200.
EEO Statement Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
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Engineer/Scientist - Technical Services/Manufacturing Science (2nd Shift)
role at
BioSpace
Organization Overview This position is responsible for second shift technical support of manufacturing operations. It will interact with engineering, manufacturing, validation, quality assurance, quality control and regulatory departments. Interaction may be required with other Lilly site/contract producers of Lilly products. Knowledge of cell culture, purification and support systems used in the manufacturing of biotech products is required. Support hours are four days on – four days off from approximately 12:00 pm to 12:30 am.
Responsibilities
Monitors (trends) and analyzes production data. Applies process knowledge and data analysis skills to support the management of daily manufacturing operations. Drives solutions for products and processes.
Troubleshoots issues in conjunction with Process Teams and/or manufacturing staff on the manufacturing floor. Anticipates and resolves problems. Communicates issues in a timely manner. Assists during process‑related investigations and assesses technical impact. Serves as a key resource within a TS/MS area or discipline. Gains support for ideas or positions on difficult issues.
Assists in the transfer of processes from process development to production facilities and from one production facility to another, anticipating and addressing scale‑up issues.
Authors technical reports supporting process control strategies, technology transfers, deviation observations, process monitoring/analyses, and technical studies.
Writes standard operating procedures as they relate to the activities of the TS/MS group. Authors or revises manufacturing procedures and batch records as necessary to enable precise execution and ensure practice matches procedure. Reviews and approves manufacturing batch records and other manufacturing documentation.
Works directly with the Manufacturing staff on the manufacturing floor to share process knowledge. Assists in process‑related training of Manufacturing Process Team members. As required, directly gathers additional supporting data on the manufacturing floor.
As required, designs laboratory experiments in support of process troubleshooting and/or continuous improvement and executes or coordinates execution in outside laboratories. Helps to define and implement continuous improvements and change controls to manufacturing processes.
Works with Manufacturing to support the start‑up and validation of new facilities and the associated process equipment. Helps to implement control strategies for Lilly Branchburg processes.
As required, may lead or assist in the planning and execution of process validation activities.
Understands, and performs all job responsibilities in compliance with safety and regulatory expectations as well as cGMP.
Basic Requirements
BS degree in Chemistry, Microbiology, Biochemistry or related science, or BS in Chemical Engineering or related engineering discipline.
Position is a banded position and years of experience in a cGMP biopharmaceutical or pharmaceutical manufacturing and/or development environment will be considered in initial placement within the band.
Excellent communication skills, both oral and written.
Additional Skills/Preferences
Experience in fermentation/cell culture and/or protein purification manufacturing.
Process and equipment knowledge of cell culture or purification functions.
Thorough understanding of GMP requirements for a large scale manufacturing facility.
Demonstrated leadership skills.
Additional Information Travel:
Shift: Support hours are approximately 2 PM – 10 PM Wednesday, 2 PM – 12 AM Thursday, 2 PM – 12 AM Friday, 12 PM – 12 AM Saturday.
Compensation Actual compensation will depend on candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $72,000 – $189,200.
EEO Statement Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
#J-18808-Ljbffr