Manufacturing Manager

Grand River Aseptic Manufacturing Inc.; Grand Rapids (MI); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical, prescription, dental, vision,

Life insurance

Paid time off

Paid holidays

401(k)

Volunteer time off

Job summary

Grand River Aseptic Manufacturing Inc. (GRAM) is seeking a senior leader to manage Drug Product Manufacturing Operations, including sterile filling and aseptic processing. You will own processes and equipment at the Butterworth facility and support expansion to Patterson North, driving throughput and regulatory compliance.

You will lead a team, ensure CAPAs are effective, and partner with Quality to meet capacity, quality, and customer service targets in a fast-paced, science-driven environment.

Qualifications

• Bachelor's degree in Life Sciences/Engineering or related field; equivalent work experience considered.
• Minimum 5 years of leadership in a cGMP pharmaceutical/regulated manufacturing environment.
• Experience with regulated drug manufacturing, cGMP, FDA guidelines, and multinational standards.
• Proficient in Word, Excel, and Outlook.

Responsibilities

• Manage Drug Product Manufacturing Operations including Preparation, Formulation, Filtration, and Sterile Filling.
• Serve as Process Owner for Butterworth Facility processes and equipment, including cleanroom control.
• Oversee daily/weekly/long-term manufacturing activities to meet capacity, quality, and customer service.
• Train and provide leadership oversight during expansion to Patterson North facility.
• Ensure scheduling and resource planning to meet production plans.
• Drive improvements, CAPAs, and adherence to regulatory requirements.
• Lead cross-functional teams and participate in technology transfer and process changes.

Skills

Leadership

cGMP expertise

FDA guidelines

Six Sigma/Lean

CAPA/Deviations

Regulatory documents

People development

Data analysis

Cross-functional collaboration

Shop floor leadership

Education

Bachelor's degree in Life Sciences/Engineering

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

life insurance, paid time off, paid holidays, 401(k)

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!

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 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.

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 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.

Preferred Requirements:

• 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.

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.

What Sets GRAM Apart from Other Employers:

BENEFITS starting day 1: Medical, prescription, dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying a portion 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!

PAID TIME OFF: You choose how to use this time for your vacation, sick, or mental health needs! PTO: Full-time employees accrue up to 104 hours of paid time off per calendar year, with this amount being prorated your first year. WELLNESS TIME OFF (WTO): In addition to PTO, employees earn 1 hour of wellness 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.

Full job description available during formal interview process.