Microbiology Scientist II (4 Month Position) - Morrisville, NC

Pace Life Sciences

Pace makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace provides professional services to support their operations.

NOTE: The Microbiology Scientist 2 position is expected to last 4 month

Overview
The Microbiology group at Pace RTP is responsible for the microbial testing support for external analytical services for clients of Pace Life Sciences. The microbiology team performs microbiology testing (sterility, microbial limits, endotoxin testing, etc.) for API, Finished Product, Stability, Raw Materials and Components.

Summary
Primary duties include performing microbiological method development and verification, testing of raw materials and sterile and non-sterile pharmaceutical dosage forms, and general support activities within the Microbiology group. An individual in this role functions as a microbiology technical lead and provides technical guidance to junior analysts.

This Scientist role usually works with some supervision, conferring with superior on unusual matters. May be assisted by laboratory technicians/assistants or Scientist I. Assignments are broad in nature, requiring originality and ingenuity. Has appreciable latitude for un-reviewed action or decision. They may direct projects and employees, taking on a technical lead role. Comply with divisional and site Environmental Health and Safety requirements.

Responsibilities

• Develop and execute laboratory work plans/schedules independently, using customer milestones and Division/site performance standards and metrics
• Authors technical documents, such as protocols, test methods, text reports, certificates of analysis, operating procedures and investigations
• Review technical documents for accuracy, thoroughness and regulatory compliance
• Trains, coaches or mentors others on technical, personal development or business issues
• Responsible as Project Director with responsibility for project outcome and customer interaction
• Executes efficiency improvement project with guidance
• Identify and recommend business opportunities on a project specific basis
• All other duties as assigned

Qualifications
Education

Masters degree, Bachelors degree, or Associates degree in Microbiology, Biology or closely related physical science from a four-year college/university or equivalent education and training

MS and 2-3 years related experience, BS and 4-5 years related experience, or equivalent education, experience and training

Knowledge, Skills and Abilities

• Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs
• Ability to learn and retain technical information
• Proactively address work issues at both an individual level and a team level
• Develop and execute complex procedures or methods of moderate complexity with high quality
• Becoming familiar with drug development milestones and their context.
• Recognizes and elevates changes in project scope or execution for review by project director
• Able to prioritize and suggest alternatives or contingencies to achieve the correct technical solutions with most efficient resource utilization
• Propose deviations from established procedures and methods based upon sound judgment
• Excellent written and verbal communications skills with internal and external customers
• Can organize and manage teams chartered to address resolution of lab issues or special projects with general management guidance
• Lead by example according to Pace values and culture
• Can assess training needs and formulate development plans for subordinates
• Recognize unmet customer needs
• Can effectively back-up supervisor to address limited technical or business issues with prior instructions
• Strategy is focused on personal and team time management and efficiency
• Well organized with ability to multitask
• Ability to work effectively under pressure to meet deadlines

Physical Qualifications

• On an average 8 hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds
• Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently
• May require the use of a respirator