Assay Transfer /Qualification Scientist I *PC 617

Your Role:

This position is primarily responsible for driving the daily Quality Control activities associated with Biological/Molecular Assay Transfer and Qualification/Validation, with minimal to no supervision. Additionally, this role performs and/or supports timely completion of QC test methods.

Essential Duties and Responsibilities:

• Optimization/ robustness, Transfer and Qualification or Validation of Analytical methods for lot release of GMP Assays (and Non GMP Assays as applicable) with minimal to no supervision. Qualification or Validation tasks will include writing Protocols and Reports, executing and reporting qualification or validation activities, writing and revising SOPs.
• Design and execute stability studies for critical reagents and cell therapy products.
• Maintain accurate and complete records of all assay transfer, qualification or validation activities per cGMP.
• Assist in the evaluation and implementation of new technologies associated with Biological and Molecular Assays with minimal to no supervision.
• Maintain inventory of QC materials and lab supplies, including monitoring and ordering.
• Perform and/or support timely completion of QC test methods e.g. flow cytometry, Nucleic Acid Extraction, qPCR, ddPCR, ELISA, cell line expansion and qualification.
• Assist in troubleshooting and evaluation of executed Biological and Molecular Assays with minimal to no supervision.
• Facilitate and support OOS Investigations and participates in CAPAs, Deviations, other investigations, as needed.

Requirements:

• Bachelor's Degree in life sciences or relevant discipline required, master's degree in life sciences or relevant discipline preferred; A minimum of 5 years related experience and/or training; or equivalent combination of education and experience.
• Technical proficiency and experience with Biological and Molecular Assay methodology.
• Fundamental understanding of analytical method lifecycle, including assay qualification, validation, transfer and maintenance.
• Strong knowledge of GMP compliance and Quality Control.
• Strong Quality orientation with attention to detail.
• Must have practical experience using statistical methods. Experienced with MS Office. Specifically, Word, Excel and PowerPoint Statistical methods of Data Analysis.
• Excellent written and oral communication skills and must be able to interact with a cross-functional team member.
• Strong understanding of industry standards such as ICH, EP, FDA, and USP as they apply to Cell therapy products.
• Some flexibility to cover production and peak run schedule.

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 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 facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a clean laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes and computers. While performing the duties of this job, the employee is exposed to viruses and bacteria. Employees entering the laboratory must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate.

The anticipated base salary range has been established at $96,900 - $131,100. The hiring range for this position is expected to fall between $96,900 - $114,000, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.

The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company's good faith and reasonable estimate of possible compensation at the time of posting.

In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions.

Miltenyi Biotec, Inc is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

Miltenyi Biotec, Inc. participates in E-Verify.

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact - one breakthrough at a time. One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry - our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.