Aseptic Manufacturing Manager

Grand River Aseptic Manufacturing
US - Michigan - Grand Rapids
November 9, 2024

Quality, Service, Collaboration, Courage.

Do you exhibit these values and wish to be around others that do too? Are you interested in making a difference in your community and the world? Are you looking for a place where you can grow and learn in a diverse, community-minded culture? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day.

Overview of this Position:

This position manages all aspects of Drug Product Manufacturing Operations including Preparation, Formulation, Filtration, and Sterile Filling of parenteral products. Functions as Process Owner for processes and related equipment for the Front Facility, including cleanroom control and maintenance. Responsible for the daily, weekly, and long-term manufacturing activities to meet capacity, quality, and customer service requirements.

Non-Negotiable Requirements:
Bachelor's degree in Life Sciences/Engineering or in another relevant field. In lieu of a bachelor's degree, equivalent work experience may be considered.
Minimum of 3 years of leadership experience in a cGMP environment in the pharmaceutical, biotech, or other regulated manufacturing environment; an inspiring and enabling leader who creates opportunities for growth. A minimum of 5 years preferred. Candidates with higher years of experience may be considered a Sr. Manager.
Must have proficient computer skills in Microsoft Word, Excel, and Outlook.
Responsibilities Include (but are not limited to):

Ensure the department's activities remain in or exceed the standards and specifications established by Quality Assurance and clients.
Work closely with Quality to provide to troubleshoot processes, investigate deviations and ensure implementation of appropriate CAPAs within the required timeframes.
Review, assess and approve CAPAs and non-conformance reports, including deviations.
Champion and lead continuous improvement efforts.
Ensure capacity availability of resources (room/equipment/staff) to perform commercial and clinical manufacturing to meet the annual demand planning and monthly production planning requirements.
Responsible for the efficient and effective weekly scheduling of Preparation, Formulation and Filling work centers to support production plans.
Balance quality, productivity, cost, safety, and morale to achieve production goals.
Ensure personnel are properly trained and following approved processes to facilitate the manufacturing of quality goods based on cGMPs, SOPs, regulatory requirements, and/or company policies.
Analyze and interpret data, identify problems, and makes decisions involving production issues.
Drive key performance indicators to all levels within the organization and participate in making recommendations for necessary changes to enhance the business objectives.
Ensure consistency of operations across shifts through active engagement on the shop floor and through Gemba walks and Practice vs. Procedure evaluations.
Provide leadership to Manufacturing team, Supervisors and Professionals
Responsibility includes hiring, managing, motivating, coaching, and mentoring.
Actively participate/contribute to technology transfer, start-ups, design and implementation of process changes, typically working on cross-functional teams.
Partner with other departments regarding the resolution of ongoing problems and implementation of new procedures or processes.
Represent the Manufacturing team during client facing interactions.

Full job description available during formal interview process.

What Sets GRAM Apart from Other Employers:

MEDICAL BENEFITS starting day 1:

Blue Cross Blue Shield medical and dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying for 75% of the cost! Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well. We also offer generous off-shift premiums!

Paid VOLUNTEERISM starting day 1:

GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!

PTO:

Full-time employees accrue up to 17 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!

WELLNESS TIME OFF:

We offer all employees one (1) paid day of Wellness Time Off (WTO) per quarter to invest in self-care, take some downtime, or whatever you choose.

PAID HOLIDAYS:

We offer 10 paid holidays per calendar year with immediate eligibility!

PAY:

Depends on Experience and is discussed during the interview process.

If you meet the required criteria listed above, GRAM welcomes you to apply today!

Read the full job description and apply online on the recuiter's web-site

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