Bioanalytical Project Manager/ Principal Investigator


[OPEN]

COMPANY DESCRIPTION

At Somru Bioscience, we are passionate about science and the impact it has on our world. Our team of highly experienced scientists offer world class bioanalytical services enabling breakthrough medicines to market. At Somru, you will have the opportunity to develop your career working side-by-side with experienced scientists serving numerous clients while you enable life-changing, life-saving therapeutics to the patients who need them.

Job Description

Bioanalytical Project Manager is the primary point of contact for our external customers. The focus of the Project Manager is to provide exceptional customer service while ensuring that all work meets our scientific and regulatory standards.

Responsibilities

  • Provide oversight and conduct of a project throughout its life, including method development, method validation, and sample analysis
  • Serve as Principal Investigator for GLP studies
  • Work closely with Technical Writing and QA to ensure projects are completed on schedule
  • Review validation and bioanalytical reports for completeness
  • Maintain all communication with customers providing daily updates on all active projects while being vigilant for opportunities to earn additional business
  • Work with the customer to resolve sample discrepancies
  • Monitor the progress of all assigned projects and alert management if work falls behind schedule
  • Provide regular project status updates to management
  • Participate in weekly scheduling and revenue update meetings and provide updates on project progress
  • Submit accurate weekly assessment of resource requirements for scheduling purposes
  • Prepare validation and sample analysis plans
  • Review data (run binders, data tables, etc) for regulatory compliance and scientific quality. Address issues from QC and QA review for run binders
  • Conduct thorough investigations of all failed runs
  • Lead method troubleshooting investigations. Assemble group of pertinent technical resources and write up investigation report
  • Provide project trackers for client communications and lead regular teleconferences to discuss project progress
  • Coordinate customer visits. Visit customers
  • Ensure projects are archived in accordance with company SOPs
  • Comply with all applicable regulatory standards, including Good Clinical and Good Laboratory Practices

Requirements and Qualifications

  • Bachelor's Degree scientific field
  • 5 years’ related experience. Equivalent combination of education, training, and experience in GLP laboratory environment
  • Ability to achieve results through collaborative efforts with others
  • Ability to develop immunoassays in some or all the following immunoassay platforms: ELISA, MSD-ECL, RIA, DELFIA, HTRF, and AlphaScreen
  • Understanding of method development and validation of assays
  • Ability to interact with external and internal clients, and work to objectives/timelines
  • Excellent attention to detail and communication skills
  • Must work effectively within team to meet objectives under time constraints
  • Ability to take direction well and multi-task
  • Detail oriented and highly organized
  • Excellent oral and written communication skills
  • Proficient in the use of MS Excel and Word
  • Knowledge and application of regulatory guidance to experimental planning and design
  • Experience working in GxP environments and demonstrated knowledge of GxP regulations

 

If you are interested in being considered for this position, email your resume to: hr@somrubioscience.com. Please indicate “Bioanalytical Project Manager/ Principal Investigator” on the subject line of your email.

 

Somru BioScience Inc.

19 Innovation Way

Charlottetown, PE, C1E 0B7

TEL: 902-367-4322 | Fax: 902-367-4323

E-MAIL: hr@somrubioscience.com

Web:http://www.somrubioscience.com

Contact information

Somru BioScience Inc.
19 Innovation Way
BioCommons Research Park
Charlottetown
Prince Edward Island, C1E 0B7
Canada
customer@somrubioscience.com