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- Perform production operations including fermentation or cell culture operations, preparation of solutions, chromatographic separation, filtration and concentration operations, autoclave and parts washing of process assemblies, and area cleaning/upkeep.
- Will be responsible for completing daily manufacturing tasks, and increasing competency in different production areas over time.
- Will participate in safety and compliance initiatives, as well as investigations.
- Will engage in the Production System to continuously improve safety, quality, and schedule/cost performance.
- The purpose of this role is to be a part of a dynamic, multi-tiered operations team that brings life changing and lifesaving medicine to patients around the world.
- Under the direction of senior personnel, the biopharmaceutical manufacturing associate II performs a variety of largescale production operations, interacting with automated equipment and monitoring/processing data.
- Will be responsible for completing daily manufacturing tasks and increasing competency in different production areas over time.
- Will participate in safety and compliance initiatives, investigations, and help solve technical and organizational problems while working with different teams of experts.
- Will work within these teams to continuously improve safety, quality, and schedule/cost performance.
- With good documentation and data integrity practices, safely and compliantly completes and documents daily manufacturing tasks per standard operating procedures, batch document instructions, and logbooks
- Proactively works with senior staff to achieve competency in production operations
- Supports in cross-functional activities, such as engineering actions, validation actions and Tech Transfer actions, including proactive safety and compliance input prior to execution.
- Primarily these activities are within the production suite, but sometimes require out of suite or off-site work (i.e. FAT support)
- Monitors equipment and critical process parameters, and escalates any issues or abnormalities and participating the resulting troubleshooting activities
- Strives to maintain a high level of competency with current and emerging digital platforms (SAP, EBR, AR/VR, etc)
- By learning the production schedule and assessing it daily, proactively ensures all processing equipment and necessary materials are adequate and available to set the team up for success
- Transparently participates in investigations that are the result of safety or compliance issues.
Description
- Perform production operations including fermentation or cell culture operations, preparation of solutions, chromatographic separation, filtration and concentration operations, autoclave and parts washing of process assemblies, and area cleaning/upkeep.
- Will be responsible for completing daily manufacturing tasks, and increasing competency in different production areas over time.
- Will participate in safety and compliance initiatives, as well as investigations.
- Will engage in the Production System to continuously improve safety, quality, and schedule/cost performance.
- The purpose of this role is to be a part of a dynamic, multi-tiered operations team that brings life changing and lifesaving medicine to patients around the world.
- Under the direction of senior personnel, the biopharmaceutical manufacturing associate II performs a variety of largescale production operations, interacting with automated equipment and monitoring/processing data.
- Will be responsible for completing daily manufacturing tasks and increasing competency in different production areas over time.
- Will participate in safety and compliance initiatives, investigations, and help solve technical and organizational problems while working with different teams of experts.
- Will work within these teams to continuously improve safety, quality, and schedule/cost performance.
- With good documentation and data integrity practices, safely and compliantly completes and documents daily manufacturing tasks per standard operating procedures, batch document instructions, and logbooks
- Proactively works with senior staff to achieve competency in production operations
- Supports in cross-functional activities, such as engineering actions, validation actions and Tech Transfer actions, including proactive safety and compliance input prior to execution.
- Primarily these activities are within the production suite, but sometimes require out of suite or off-site work (i.e. FAT support)
- Monitors equipment and critical process parameters, and escalates any issues or abnormalities and participating the resulting troubleshooting activities
- Strives to maintain a high level of competency with current and emerging digital platforms (SAP, EBR, AR/VR, etc)
- By learning the production schedule and assessing it daily, proactively ensures all processing equipment and necessary materials are adequate and available to set the team up for success
- Transparently participates in investigations that are the result of safety or compliance issues.
Qualifications
- BS/BA degree, with cGMP manufacturing experience; OR
- Associate's degree from Montgomery county community college in Biotechnology or related technical field with cGMP manufacturing experience; OR
- High School degree, 1+ years of cGMP manufacturing experience.
- Demonstrated level of high performance
- Strong verbal and written skills
- The ability to work well in a team environment
- Must be able to follow detailed processing instructions as well as accurately documenting all necessary documentation.
- Live Expectations of Courage, Accountability, Development, and Teamwork to achieve high performing behaviors in the workplace.
- Demonstrate Values (Patient Focus, Transparency, Respect, & Integrity) and Expectations (Courage, Accountability, Development, & Teamwork) on a daily basis by engaging positively with team members and production support groups.
- Flexibility to work any shift is required
Benefits
Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.
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