Job Description: How will you make an impact?

• The candidate will be responsible for the performance of operations in support of the manufacture of Commercial and Clinical Biologics.

• He/She will be responsible for following Current Good Manufacturing Practices (cGMPs) and carrying out a variety of functions related to preparation and organization of the manufacturing suites.

  What will you do?

• Perform cleaning of manufacturing suites

• Assist with delivery of raw materials and consumables to the manufacturing suites

• Ensure lines, kits, and assemblies are moved to the manufacturing suites to meet processing needs in order to prevent delay

• Confirm formulations are available prior to need. Ensure formulations move to manufacturing suites for production processing needs

• Support ancillary tasks on the manufacturing floor such as fit and finish, material stock/supply and equipment staging.

• Participate in shift exchanges, 1-1’s, meetings, attend meetings as necessary to facilitate area needs based on changes, etc. (lean activities).

  How will you get here? Education:

• High school degree required. Associates in a relevant scientific discipline preferred.

  Experience:

• No experience required, but 1-3 years of relevant experience in a manufacturing and/or GMP environment preferred, preferably in pharmaceutical manufacturing.

  Knowledge, Skills, Abilities:

• Knowledge

• Knowledge of cGMP practices seen as a plus

  Skills:

• MS Office

• Inventory Management – SAP experience a plus

• Time management and prioritization

• Detail oriented

• Results driven

  Abilities:

• Able to read, write, and communicate in English

• Able to understand and carry out instructions

• Organized

• Reliable

• Active communication (written and verbal)

• Able to work in an environment of change

• Able to work independently and as part of a team

• Able to recognize problems developing, not just occurring

  Requirements:

• Be willing to wear a full gowning suit which includes: body suit, gloves, hair and beard nets, face covers, and safety glasses.

• Gowning material includes wearing Tyvek, Nitrile, and/or Latex gloves. (These items are prohibited: makeup, jewelry, nail polish, cologne and perfume.

• Must be able to wear a respirator.

• Able to lift minimum of 25 lbs independently and able to stand for 80% of shift.