Current jobs related to cGMP Lab Scientist - Rush - IUVO BIOSCIENCE OPERATIONS, LLC

iuvo BioScience is a Premier Partner Research Organization serving the Medical Device, Pharmaceutical, and Ophthalmic industries. We provide strategic guidance and testing services – from research to release - leveraging our preclinical testing, CMC/technical services, and clinical research experience to deliver exquisite science, develop valuable insights, and author flawless documentation. We do it all with a commitment to exceptional service.

We offer a comprehensive benefits package (medical/dental/vision/401k/PTO) and the opportunity to broaden your experience working with top level medical device and pharmaceutical clients to improve the quality of life for patients and consumers around the world.

We currently have an opening for a SCIENTIST to join our Microbiology team.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The responsibilities with respect to testing and project work in a cGMP laboratory:

• Conduct routine Microbiological testing as defined by cGMPs, work instructions, SOPs and relevant standards.
• Lead and support complex projects related to
  • microbiological testing (ex: sterility, bioburden, environmental monitoring, water)
  • reusable medical device cleaning, disinfection, and sterilization
  • facility cleaning and disinfection efficacy studies
  • laboratory instrument and equipment IOQ/PQ
• Document work and analyze data using basic statistical tests
• Identify and investigate non-conforming product according to cGMPs
• Prepare, review, and approve GMP and GLP protocols and reports
• Review and approve data generated by other operations personnel
• Develop and validate new methods

Managerial duties:

• Supervise or direct assigned technicians on a project basis
• May directly supervise one or more employees. Responsibilities may include assisting with interviewing, training employees, directing work and appraising performance.

Additional Responsibilities:

• Develop and write work instructions and SOPs
• Provide and implement solutions to problems encountered
• Initiate and implement preventative and corrective actions
• Requisition and approve purchase of raw materials and supplies
• Perform tasks delegated by management with appropriate supervision
• Evaluate equipment and resource requirements
• Maintain laboratory including assigned equipment maintenance and calibrations
• Other tasks as assigned by management

QUALIFICATIONS & REQUIREMENTS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

EDUCATION and/or EXPERIENCE

Bachelor's degree (B.A. or B.S.) in science. With three to five years of prior cGMP laboratory testing experience. Ability to read, understand and operate laboratory equipment. Skill with laboratory techniques.

Experience in the following areas strongly preferred:

o Medical device cleaning, disinfection and sterilization studies

o GMP sterility testing of pharma and med devices

o Rapid sterility testing

o cGMP raw materials, finished product and stability testing for pharmaceuticals

o Development and execution of complex studies related to microbiology

o Steam sterilization and EtOH sterilization

COMPUTER SKILLS

Proficiency with Microsoft Office (Word, Excel, Outlook, PowerPoint) and programs specific to the lab tools and instrumentation.

COMMUNICATION SKILLS

Ability to read, analyze, and interpret technical procedures. Ability to write reports, correspondence, and procedures. Ability to effectively present information and respond to questions. Ability to speak effectively to employees of the organization. Ability to interpret results and communications in writing.

MATHEMATICAL SKILLS

Ability to calculate figures and amounts such as proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra, geometry and statistics.

OTHER SKILLS and ABILITIES

Ability to apply common sense understanding to carry out instructions furnished in written, verbal, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Must be able to schedule tasks, organize time and plan work effectively.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to stand, sit and walk, use hands to manipulate objects or controls, reach with hands and arms, talk and hear.

The employee must frequently lift and/or move up to 30 pounds and occasionally lift and\or move up to 50 pounds. Specific vision abilities required by this job include close, color, and peripheral vision and the ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Combination of office and laboratory settings (with typical laboratory risks) where moderate noise levels may exist.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

LOCATION Rush, New York

TRAVEL None

DISCLAIMER

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

iuvo BioScience is an Equal Opportunity Employer