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 Aseptic Manufacturing Lead is 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.

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.
• Well versed in cGMP and GDP.
• Proven leadership experience and self-starter.
• Proficient computer skills in Microsoft Word, Excel, and Outlook.
• Qualification for use of a full-face respirator is required.

Preferred Requirements:

• Experience in a CMO and sterile filling facility preferred.

Responsibilities Include (but are not limited to):

• Provide support to the manufacturing team when performing component and equipment preparation, bulk drug formulation, aseptic formulation, and aseptic filling 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.
• Assist in MBR creation and revision, as necessary.
• Assist in the day-to-day scheduling of production operations.
• Clearly communicate direction to manufacturing and cross-functional teams.
• Assume responsibility in the absence of manufacturing supervision.
• Communicate shift progress reports to team and/or management in the absence of shift supervision.
• Assist in the performance of routine maintenance on production equipment.
• Participate in client communications, including problem solving, schedule development, and project status updates.
• Foster a positive team environment that promotes productivity and employee satisfaction.

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. Shift differential available for second and third shift!