Manufacturing Associate (Pharmaceuticals)

A pharmaceutical company is seeking to hire a Manufacturing Associate for a 12-month contract. Manufacturing Operates 24/7, so position requires multiple shift coverage.

Shift Choices:

• 6:00AM-7:00PM or 6:00PM-7:00AM
• Sunday-Wednesday, alt Tuesday or Wednesday-Saturday, alt Wednesday

Responsibilities
 
Process Knowledge:

• Understanding of process theory and equipment operation.

• Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, protein purification and formulation of bulk drug substance.

• Support initiatives for process optimization.

• Identify and elevate processing issues and support solutions.

• Demonstrated proficiency Gain experience with automation systems (LIMS, MES, PI, etc.).

Technical Documentation:

• Provide feedback and/or suggested changes to operational procedures.

• Assist in the incorporation of new technologies, practices and standards into procedures.

• Capable of writing and reviewing process documents.

Quality and Compliance:

• Understanding of cGMPs as related to Commercial Operations.

• Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)

Business:

• Ability to participate on projects and contribute to outcomes.

• Capability to learn and support new business systems (Track wise, ERP, etc.).

• Support trending of defined department metrics.
   

Qualifications

• Bachelor's degree in science or engineering and 1 year of experience or Associate’s degree in science related area or Biotech certificate with 2 years of experience in a biotech manufacturing environment or other regulated industry.