Junior Biologics Process Operator with Chromatology Purification Experience

Company Name:
Alpha Consulting Corp.

AUGUST 26, 2014

Project Description:
The Processing Specialist will work within the Hopewell Clinical Manufacturing Upstream Processing group. The specialist will perform the following activities while executing upstream operations:
Purification and packaging of protein based pharmaceuticals
Preparation of stock solutions
Filtration of stock solution
Cleaning, set-up of Chromatography skids, Filtration Skids and Columns.
Set-up and operation of disposable bioprocess equipment
Pack and Unpack Chromatography Columns
Stock raw materials and consumables
Remove waste from facility
Works on routine manufacturing assignments per written procedures, where ability to recognize deviation from accepted practice is required.
Adheres to current Good Manufacturing Practices (cGMP) and standard operating procedures.
Performs mammalian cell culture using aseptic techniques.
Performs daily monitoring of mammalian cell cultures and bioreactors.
Weighs and checks raw materials, assembles and cleans process equipment, & monitors processes.
Completes work instructions and maintains clean room environment to comply with regulatory requirements.
Trains for proficiency in the operation of primary production equipment such as stainless steel bioreactors, disposable bioreactors and other disposable equipment, and media preparation equipment
Authors and approves master batch records (MBRs) by transferring technical information from scientific and development documents.
Collaborates with equipment and instrument vendors to become subject matter expert. Authors, revises and approves SOP's for such equipment.
Leads or participates on Operational Excellence cross-functional project teams, including but not limited to Development, Quality, Analytics, Logistics, Facilities and Document Center. Utilizes Continuous Improvement and Project Management tools for completion of projects.
Investigates deviations for root cause and determines appropriate corrective actions (CA) and preventative actions (PA).
Implements CAPA within agreed upon timelines.
Designs and implements single use technology process consumables for new molecule facility fit and continuous improvement.
Conducts Safety and GMP self-auditing walkthroughs, documenting observations for assignment and closure dates.
Logs and submits samples in LIMS. Tracks results and compiles data.
Reviews and signs-off on completed batch records.
Assists mechanics and instrument techs with product change-over of equipment and manufacturing areas.
B.S. in science-related or engineering-related with a minimum of 0 years prior experience, or Associates in science or engineering with a minimum of 1 years relevant experience, or High school diploma with a minimum of 5 years' experience.
Experience with aseptic technique, chromatography purification preferred.
Practical knowledge of pharmaceutical regulations including cGMP.
Experience operating under Work Instructions (WI) and Standard Operating Procedures (SOP).
Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected.
Demonstrated proficiency in computer tools such as word processing, spreadsheet and web based applications.
Previous work experience where attention to detail and personal accountability were critical to success.
Demonstrates good interpersonal skills, is attentive and approachable.
Maintains a professional and productive relationship with area management and co-workers.
Physical/Environmental Demands:
This position is located in a medium scale manufacturing facility with classified areas requiring appropriate personal protective equipment (PPE). This role will require handling/use of hazardous materials such as caustic, acids and steam. Frequent bending, twisting, squatting, kneeling, climbing and reaching is required. Role also requires infrequent unassisted lifting (not to exceed 50 lbs). Repetitive use of arms/hand/wrists, grasping is also required. This position is a team based position that requires off-shift work, weekends, holidays and overtime.

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Jessica:

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