Manufacturing Manager (off shift or weekend)

Description

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:

The Manufacturing Manager's primary responsibilities include managing all aspects of drug product manufacturing operations including preparation, formulation, filtration, and filling. Functions as the process owner of these processes and related equipment for the Butterworth Facility, including cleanroom control and maintenance. Responsible for the daily, weekly, and long-term manufacturing activities to meet capacity, quality, and customer service requirements. This position primarily supports the Butterworth facility, and the working hours will align with either the off shift or weekend crew.

Non-Negotiable Requirements:

• Bachelor's degree in Life Sciences/Engineering or in another relevant field.
• Minimum of 5 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.
• Experience in pharmaceutical packaging of regulated products with a thorough understanding of cGMP, FDA guidelines and multinational regulatory standards is a must.
• Six Sigma and Lean application understanding with knowledge of tools and proven positive outcomes.
• Leadership experience with emphasis on personnel training, development and mentoring, problem solving, and working with tightly controlled regulatory documents.
• Demonstrated proficiency for evaluation of drug formulation, aseptic processing, filtration, filling, inspection, labeling, packaging, and equipment utilization.
• Advanced understanding of the quality system and process controls approach, as well as knowledge of cGMP, ICH, EHS regulations.
• Competent understanding of OPEX behaviors, principles and tools.
• Proficient computer skills in Microsoft Word, Excel and Outlook.

Preferred Requirements:

• Prior experience working in a fast-paced, emerging growth CMO is a plus.

Responsibilities Include (but are not limited to):

• Consistently promote the plant safety program, lean initiatives, training program and HR policies while holding employees accountable to follow all site policies, practices and procedures while also delivering results.
• Ensure the department's activities remain in or exceed the standards and specifications established by Quality Assurance.
• Work closely with Quality to provide 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 manufacturing documentation is closed out in a timely manner.
• Support customer relations' efforts by meeting customer standards and delivery dates
• 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 make 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.
• 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, the implementation of new procedures or processes, the injection of new products or product lines, and the development of new plans and designs.

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 13 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: Employees earn 1 hour of time off for every 30 hours worked to use how 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.