Manufacturing Supervisor - Cell and Gene Therapy (Swing Shift) •PC 1521

Description

Your Role :

As a member of the Miltenyi Biotec Manufacturing team, you will have the exciting opportunity to oversee and participate in day-to-day GMP processes and production activities for the manufacturing team at our facility. The unique duties of this position will primarily consist of training and managing the performance of the Manufacturing (MFG) Cell and Gene Therapy (CGT) GMP staff while supporting the development of scalable processes.

Furthermore, you will be responsible for developing documentation, reviewing / creating / adhering to MFG schedules, monitoring the maintenance of production equipment and investigating all failures to support the GMP manufacturing suites, equipment and facility operations.

Overall, your ability to drive continuous improvement in a GMP controlled environment while motivating and collaborating across diverse disciplines will champion the continued development of Miltenyi Biotec products and growing success.

Essential Duties and Responsibilities :

• Performing and coordinating day to day activities across shifts with peers and manufacturing staff; generating end of shift reports / escalation; maintaining cleanroom presence; resolving or provide resolutions to manufacturing process issues.
• Authoring, reviewing, revising and approving Batch records, SOPs, Manufacturing Change Control, and CAPAs.
• Coordinating APS / APQ, clinical and commercial manufacturing schedules, semi-annual PM and calibration for manufacturing equipment.
• Implementing GDP and GMP, continuous improvement Initiatives, 5S and lean manufacturing.
• Working closely with the manufacturing team in creating and implementing Manufacturing / Operators Standard ways of working in accordance to Quality, Safety and Data integrity.
• Collaborate with Facility Maintenance, Validation and QA with commissioning and start up activities.
• Responsible for interviewing / hiring; training; mentoring, developing and reviewing performance to strengthen and grow a manufacturing team.
• Manage, review and approve Manufacturing Associates individual schedules, goals, and timesheets.

Requirements :

Knowledge :

Skills :

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 :

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 hiring range for this position is expected to fall between $88,100-$103,650 / 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 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.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.