Hybrid Principal Scientist, Contamination Control Strategy – ADN RAMP Team

Posted 3 weeks ago

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About the role

  • Responsible for the development, implementation and establishing ongoing monitoring of the Contamination Control Strategy (CCS) for new site facilities
  • Design, implement, support validation of and maintenance of routine and Batch Specific environmental monitoring (EM) programs
  • Liaise with engineering on the New Facility design requirements to support CCS
  • Provide microbiological control strategy support for Raw Materials
  • Liaise with Quality Assurance to ensure microbiological controls are considered
  • Provide Microbiological support to C&Q and cleaning validation
  • Ensure implementation of the microbiological requirements for the integrated product control strategy
  • Provide direction on handling of non-conforming results
  • Stay current with Industry trends and updates to applicable guidelines

Requirements

  • BSc Microbiology, Biochemistry or related science field with 8-10 years’ experience in pharmaceutical manufacturing
  • MSc Microbiology, Biochemistry or science-related field with minimum 5 years appropriate industry experience
  • Deep technical interest and understanding of Contamination Control Strategy
  • Excellent verbal and written communications skills
  • Strong analytical and problem-solving skills
  • Collaborative skills with operations, process engineering, QCL and other process team members
  • Technical knowledge of microbial and viral product control
  • Ability to coach others
  • Ability to influence without authority
  • Ability to clarify and simplify complex issues
  • Strong trust building with peers and leaders
  • Willing to work off-shift hours as needed to support project milestones and training of new employees.

Benefits

  • Health insurance
  • 401(k) matching
  • Pension
  • Vacation benefits
  • Medical benefits
  • Dental benefits
  • Vision benefits
  • Prescription drug benefits
  • Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
  • Life insurance and death benefits
  • Time off and leave of absence benefits
  • Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Job title

Principal Scientist, Contamination Control Strategy – ADN RAMP Team

Job type

Experience level

Lead

Salary

$64,500 - $167,200 per year

Degree requirement

Bachelor's Degree

Location requirements

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