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Sr QC Analyst, Stability Program and Raw Material at Miltenyi Biotec Inc

Posted in Other 30+ days ago.

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Type: Full Time
Location: Gaithersburg, Maryland





Job Description:

SR. QC SPECIALIST, STABILITY PROGRAM AND RAW MATERIAL
GAITHERSBURG, MD

Your Tasks:
As a member of the Lentigen Quality team, you will have the responsibility of establishing, maintaining and coordinating Lentigen's Quality Control Stability and Raw Material programs. You will lead and create stability study protocols, including study set up and testing coordination, both internally and externally. You will also have the opportunity to evaluate, trend and generate milestone status updates and final stability reports ensuring accuracy and GMP compliance. Additionally, you will be responsible for ensuring all stability testing is pulled as per the established protocol and tested according to the SOP requirements. You will also manage and monitor on-time closure of laboratory investigations, deviations, and investigations. Overall, your knowledge of GMP compliance, stability testing and raw material program creation will help empower Lentigen Technology's continued success.

Requirements:
* B.S. degree in Microbiology, or similar
* Minimum of 5 years progressive experience working in a cGMP laboratory and performing stability and raw material testing; or equivalent combination of education and experience
* Project management experience is desirable
* Knowledgeable in current Good Manufacturing Practice (cGMP) regulations, including those for advanced therapies
* Experience with sample coordination and trending data is desirable
* Aseptic filling experience is required
* Strong knowledge of US and EU pharmaceutical GMPs

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have the ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature controlled, handicap-accessible facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in an office environment Miltenyi Biotec is a company that is transforming and progressing.

Lentigen Technology Inc., a Miltenyi Biotec company, is transforming and progressing. Our culture is one of bold scientific innovation. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.

At Lentigen, we support the development and commercialization of novel treatments for human disease through the utilization of Lentiviral Vectors. We hold this widely recognized and clinically relevant method for delivering genetic materials into cells in order to modulate their function as a core strength of our company. We are scientists, engineers, physicians, support specialists, and more - all dedicated to improving scientific understanding and impacting human lives. At our Gaithersburg campus, we strive to find solutions to both the technical and conceptual barriers to the implementation of gene therapy approaches for the treatment of human disease.

Lentigen Technology, Inc. is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity