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Title:  Scientist

Description: 

This position supports the parenteral pharmaceutical manufacturing facility through the qualification and/or validation of equipment, raw materials, and manufacturing processes.  Validation activities include research, protocol writing/execution and final report generation.  Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated and implemented.  Final documents are archived and may be included in or support A/NDA submissions, and made available as needed during FDA, MHRA, and client/customer compliance audits.

  • Regular and predictable onsite attendance and punctuality.
  • Applies knowledge or quickly learns cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
  • Performs a variety of projects/studies in areas that may include Product/Process, Sterilization, Cleaning and Equipment Validation, as well as projects/studies to support Manufacturing Operations.
  • Writes protocols, reports (GTRs), Site and Master Batch Record Change Controls and Executes protocols that involves coordination with many functional areas including Production, Planning, Testing Laboratories, etc.
  • Serves as project lead with projects of intermediate scope and cross-functional teams.
  • Mentors and provides leadership to junior team members.

QUALIFICATIONS

  • Minimum:    BS degree preferably in Sciences/Engineering/Math provided the individual has relevant experience – (e.g. education or employment in sciences or validations) having a minimum of 3+ years related experience or 2+ years related experience w/ an advanced degree or demonstrated performance within a technical department within the organization

SKILLS

  • Ability to communicate effectively at all levels in verbal and written form
  • Direct or indirect industry knowledge and the ability to learn new technical information and concepts
  • Ability to work independently or in teams
  • Ability to walk some distance 1-3 miles, stand for 3-6 hours and periodically lift 10 - 40 lbs. during the workday as required
  • Ability to work any shift (1st, 2nd or 3rd) and any day of the week (7 days) as duties require

 

Location: 

Cherry Hill, NJ, US, 08003


Nearest Major Market: Philadelphia

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