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BP- Scientist Protein Purification Manufacturing
Requisition ID: 89142
Position: Full time
Open date: Sep 27, 2013 11:59:52 AM
Functional area: Manufacturing
Location: King of Prussia, Pennsylvania
Job Posting Grade: 8
Required degrees: BSc
Relocation: Not Indicated
Eligible for employee referral bonus: Yes
Employee referral bonus currency:
Employee referral bonus amount:



Bachelor of Science degree in Chemical Engineering, Biology, Chemistry, or other engineering or scientific field.  4+ years of protein purification process operations experience in a biotechnology manufacturing facility or Pilot Plant, under Good Manufacturing Practices (GMP) regulations.  Good leadership skills
• Demonstrated technical expertise and working familiarity with a number of pilot scale purification methods: Buffer Preparation, Chromatography, UltraFiltration/DiaFiltration, Depth Filtration, Column Packing, CIP/SIP
• Has thorough knowledge of cGMP requirements, SOP’s and policies
• Is able to suggest new process/operational improvements in relation to set objectives
• Possesses in-depth knowledge of how to analyze and interpret experimental/process data



• Bachelor in Chemical Engineering with 6+ years of direct purification experience in a Pilot Plant setting.  This includes experience with GE platform of purification equipment and Unicorn software
• 4+ years of cGMP experience
• 2+ years of leadership experience with direct supervisory and/or lead responsibilities
• Demonstrates an understanding of the implications of procedures and deviations within his/her own discipline
• Has demonstrated strong leadership and organizational experience



The specific duties of the role/position:
• Hands-on processing of large scale purification of biopharm bulk drug substance, under cGMP regulatory conditions: Buffer Preparation, Weighing of Raw Materials, Column packing, Chromatography, UltraFiltration/DiaFiltartion, Depth Filtration, Bulk Drug Fill, assembly, CIP and SIP of equipment
• Identifies and troubleshoots any problems in the execution of processing activities; interprets results and communicates them to the appropriate decision makers
• Performs data management tasks including recording results effectively in a laboratory notebook, batch record, or computer with minimal supervision. (i.e., tabulating and graphing results)
• Anticipates/recognizes potential problems with equipment and/or supplies, and takes action to solve or prevent problems
• Attends regular safety and cGMP training.  Maintains accurate and complete safety and cGMP records consistent with company policy and legal requirements
• Recognizes potential safety and compliance problems and takes action to rectify them.
• Maintains laboratory notebooks, logs, and batch records in accordance with company policy and legal requirements
• Prepares brief oral or written summaries of results with interpretation for “projects”.
With mentoring, prepares and communicates conclusions and recommendations for next steps, to “project” members
• Leading a team of 4-8 Associate Scientists.  Leading daily activities within the area, including scheduling, training, and resource allocation.  Serving as area supervisor in absence of Supervisor.  Provides training and guidance to less experienced personnel.  
• Authoring of procedures (SOPs), Change Controls, Safety Assessments, and various other protocols
• Leading deviation investigations and implementation of CAPAs stemming from Safety or Compliance observations.  Writes investigation reports and updates / authors procedures with minimal supervision
• Constantly striving to identify process improvement opportunities with impact on safety, compliance, and efficiency/cost  
• Demonstrates ability to perform complex data management with supervision
• Ensures less experienced manufacturing personnel comply with Standard Operating Procedures (SOPs) and that training is completed on time
• Assists with the coordination and implementation of special projects such as validation or complex investigations
• Demonstrates good interpersonal skills, is attentive and approachable.  Maintains a professional and productive relationship with area management and co-workers
• Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment

John Petraglia

Farid Ighemat

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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