Manager, Quality Control *PC 643

Your Role:

This position is responsible for managing operational activities and personnel within the QC department. They will oversee activities including analytical testing of raw materials, in-process and final products release testing, stability testing and other analytical testing, while also ensuring QC labs are in GMP compliance. This position will also be responsible for collaborating with other operational groups to achieve successful completion of manufacturing, testing and release of cell therapy products.

Essential Duties and Responsibilities:

• Develop, implement and maintain activities for QC analytical operations.
• Plan and schedule QC operation schedule and coordinate QC testing with other departments.
• Oversee QC testing is completed in a timely manner and compliant with GMP requirements.
• Review QC test records and other GMP documents.
• Ensure QC laboratory in GMP compliance.
• Establish and implement QC systems to ensure continue improved GMP compliance.
• Select, develop and evaluate personnel.
• Prepare QC analytical testing schedule and ensure testing is completed on time.
• Review test data packets, provide technical guidance to QC analysts.
• Manage non-conformance events and lead investigations.
• Develop, review and revise SOPs, protocols and reports.
• Develop, implement and improve control systems and ensure QC lab in GMP compliance.
• Select, train and mentor junior staff.
• Support other QC functions as needed.
• Assist in QC budgeting and resource planning.
• Other duties may be assigned

Requirements:

• Bachelor's Degree in biological science or related disciplines required. Advanced degree in biological science or related disciplines preferred. Minimum 5 years' experience with release testing of cellular therapy or biological products in quality control setting; or equivalent combination of education or experience.
• 2 years progressive management experience including scheduling QC operations and working with multiple shift teams.
• Solid knowledge on molecular and cell biology techniques such as PCR and flow cytometry.
• Familiarity with cGMP, GLP, ICH guidelines related to CMC quality control Prior managerial experience.

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 20 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:

This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a cleanroom setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, chromatography devices and columns, tangential-flow filtration devices and filters, peristaltic pumps and metering fill pumps, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving 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 $119,200 - $161,300/year. The hiring range for this position is expected to fall between $119,200 - $140,300/year, 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.