Manufacturing Manager

Description

Agility, Impact, Methodology. Do you exhibit these values and wish to be around others that do too? Do you thrive in fast-paced environments where agility, adaptability, and high standards go hand in hand? Are you driven to make a meaningful impact, whether through your work, your support of others, or your commitment to your community? Are you motivated by a disciplined, science-based approach that ensures consistent excellence, safety, and integrity in everything you do?

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!

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 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 will support expansion into our Patterson North facility. This role will train and work at the Butterworth facility for onboarding to provide additional leadership oversight to strengthen accountability, improve operational execution and drive throughput.

• 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 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 manufacturing of regulated products with a thorough understanding of cGMP, FDA guidelines and multinational regulatory standards is a must.
• Must have proficient computer skills in Microsoft Word, Excel, and Outlook.

• 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.

• 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 time frames.
• 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…