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:

The Manufacturing Lead supports manufacturing supervision to provide direction, leadership, and communication during routine production under the guidelines of established procedures and cGMP regulations with guidance from management. The primary location for this role is the Butterworth Facility, on shift D (Friday - Sunday, and every other Thursday, from 6:00 pm to 6:00 am).

Non-Negotiable Requirements:

• Bachelor’s degree in life science or equivalent training and/or experience is necessary.
• Minimum 1 to 2 years of relevant pharmaceutical experience required.
• Proven leadership experience and self-starter.
• Professional and positive approach.
• Leadership tendencies.
• Strong in building relationships.
• Excellent communication.
• Team player, and able to work on own initiative.
• Well versed in cGMP and GDP.
• Detail oriented.
• Must have proficient computer skills in Microsoft Word, Excel and Outlook.
• Qualification for use of a full-face respirator is required for working with hazardous chemicals during chemical dispense and addition activities.

Preferred Requirements:

• Experience in a CMO and sterile filling facility preferred.

Responsibilities Include (but are not limited to):

Personnel will perform the following under the guidance of current leadership:

• Provide support to the manufacturing team when performing cleanroom and equipment cleaning, component and equipment preparation, bulk drug formulation, and aseptic formulation duties as needed.
• Oversee operations in cleanroom environment and communicate with supervision to devise appropriate resource delegation plans.
• Assist personnel on troubleshooting and resolution of quality events.
• Participate in problem solving, conflict management, performance evaluations and 1 on 1 meetings.
• Ensure contemporaneous and accurate documentation during execution of GMP operations.
• Clearly communicate direction to manufacturing and cross-functional teams.
• Assume responsibility of respective shift in the absence of manufacturing supervision.
• Participate in client communications, including problem solving, schedule development, and project status updates.
• Coach and mentor staff on appropriate aseptic behaviors within Grade C environment.
• Foster a positive team environment that promotes productivity and employee satisfaction.
• Support departmental goals, quality standards and metrics.
• Support Agency, customer and vendor audits as needed.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
• Perform all other tasks, projects, and duties as assigned.

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.