Job Description:

The GMP Biomanufacturing Operator will work daily within Aldevron’s labs performing tasks associated with Aldevron’s GMP services. The Biomanufacturing Operator is expected to become familiar with all Aldevron products and to be able to perform most tasks associated with the purification of plasmid DNA.

Responsibilities

• Segregation, line clearance and cleaning of GMP production areas 


• Plan and submit inventory requisitions 


• Plan and preparation of production events and process plan memos 


• Coordinate production events with buffer preparation operators  


• Execute GMP dispensing projects: filtration, formulation, environmental monitoring, manual and semi-automated dispensing, and media fill and gowning qualification events; all special considerations associated 


• May include cross training on any of the items listed below 


• Upstream tasks include transformation, subculture, cell banking, shake flask growth and harvest, wave growth and harvest, fermentation, media fill events, final formulation, filtration and dispersion 


• Downstream tasks include project set up, lysis, anion exchange chromatography, and hydrophobic interaction chromatography (void and enrichment), thiophilic absorption chromatography, defiltration, small scale processing and linearization 


• Completion of all documentation associated with GMP projects 


• Coordination and sample submission with Quality Control  


• Equipment calibration and preventative maintenance 


• Assist in writing manufacturing summary reports after project completion 


• Maintain personnel training record 


• Assist with assembly and segregation of all consumables and equipment resources for GMP production runs 


• Participate and support in Aldevron’s internal audit program and provide requested information and respond to findings presented in the audit report 


• Communicate the status of operations, process issues, safety and maintenance issues to appropriate area of management 


• Follow Aldevron SOP’s and adhere to regulatory expectations 


• Completion and maintenance of GMP Bill of Materials for GMP projects 

Required Skills

• Ability to follow through on methodology, understanding that bacteria are living organisms that do not adhere to a schedule


• Ability to think critically and solve problems


• Ability to follow Standard Operating Procedures and report mistakes if they occur


• Ability to accurately record details and records


• Ability to stand, bend, sit, and lift up to 50 lbs.

Must-Haves

• 1 year of experience in a lab setting (academic labs suffice) 


• Associates of Bachelor of Science degree preferred 


• Previous pipetting experience required 

Physical Requirements

While performing the duties of this position, the employee is regularly required to see, talk and hear. The employee frequently is required to stand, walk, bend, lift up to 50 pounds, and use arms, hands and fingers for various activities. This position may stand or remain sedentary for long periods of time. This position routinely works with large pieces of equipment.

Join Us Today!

Join a team committed to making lives better. Aldevron provides high-quality plasmid DNA, proteins, enzymes, antibodies, and other biologics to help our partners achieve significant breakthroughs for a variety of life science applications.

If you would like to thank someone for referring you to this role, please apply at www.aldevron.com/careers , and include their first and last name as a referral source!

Aldevron is committed to equal opportunity for all employees and applicants. We are committed to creating a diverse workforce and consider all qualified applicants without regard to race, religion, color, sex, national origin, age, sexual orientation, gender identify, or protected veteran status among other factors.

 

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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