The Position

This position is the subject matter expert on industrial/pharmaceutical Environmental Monitoring for the facility. Ensures facility program is in line with industry, regulatory and corporate practice. The individual exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions, while maintaining a high level of compliance with cGMP. Highly independent and self-motivated, receives no instruction on routine work/prioritization and general instructions on new assignments. Skilled in matrix leadership, inspires others.

Relationships

Reports to: According to the organizational chart.

Number of subordinates with direct/indirect referral: n/a.

Essential Functions

• Site lead for the Environmental Monitoring (EM) program at site NNUSBPI. This includes area monitoring and aseptic contamination control programs and Quality risk assessment management
• Technical subject matter expert on microbiological assays, techniques and industry practices
• Participates in site audits and inspections from outside authorities; responsible for area monitoring
• High degree of understanding with respect to GMP and compliance; able to assimilate complex issues and distill recommendations into concrete actionable plans
• Collaborates cross functionally to provide EM support, this includes EM-program establishment/new construction support, investigation support, coordination of study support, EM based risk assessments and data review/analysis
• Leads training and education on basic microbiology and aseptic behaviour as needed
• Responsible for protocol and report generation to support area monitoring facility qualification
• Organizes and reviews EM trending data and writes reports summarizing the trends, independently
• Handles major deviations, CAPA investigations and corrective actions. Owns SPS and facilitates A3
• Investigates and resolves issues related assay failures, system deficiencies, deviations and equipment / assay troubleshooting, with no assistance
• Reviews/updates test method and program SOPs as needed
• Creates methods and procedures on new assignments as required
• Clean utility monitoring and risk assessment
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
• Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others
• Other duties as assigned

Physical Requirements

0-10% overnight travel required. The ability to climb, balance, stoop, kneel, crouch, crawl, reach, stand and walk. The ability to push, pull, lift, finger, feel and grasp. The ability to speak, listen and understand verbal and written communication. Repetition including substantial movement of wrists, hands and or fingers. Lifting up to 33lbs/15kg of force occasionally and/or up to 30 pounds of force frequently and/or up to 10 pounds of force constantly to move objects. The worker is required to function in narrow aisles or passageways. Visual acuity to perform close activities such as: reading, writing and analysing; and to determine the accuracy, neatness and thoroughness of work assigned or to make general observations. The working environment includes a variety of physical conditions including: inside and outside conditions including temperature changes; proximity to moving mechanical parts, moving vehicles, electrical current, working on scaffolding and high places, exposure to high heat or exposure to chemicals, fumes, odours, dust, mists, gases, or poor ventilation.

Qualifications

• Education and Certifications:
  • Bachelor's degree in microbiology, biological sciences or related field required
  • Master's degree in microbiology, biological sciences or related field preferred
  • PhD in degree in microbiology, biological sciences or related field preferred
• Work Experience:
  • Bachelor's degree with a minimum of eight (8) years in the pharmaceutical/biotech industry required
  • Master's degree with a minimum of six (6) years in the pharmaceutical/biotech industry preferred
  • PhD degree with a minimum of two (2) years in the pharmaceutical/biotech industry preferred
  • Three (3) years of experience in project management activities and cross functional team coordination preferred
  • Desirable to have a minimum two (2) years of experience in a lead role within a biotech/pharmaceutical environmental monitoring program preferred
• Knowledge, Skills and Abilities:
  • Demonstrated ability to manage development associate staff is required
  • Prior experience authoring IND or BLA sections is desirable
  • Excellent written and oral communication and presentation skills. Excellent organizational skills