Loading...

Principal Scientist

Location: 

Winnipeg, MB, CA, R3T 5Y3

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

 

PRINCIPAL SCIENTIST

 

Emergent BioSolutions is currently seeking a Principal Scientist. The successful candidate will have at minimum a Ph.D. in Biological Sciences, preferably in Pharmacology/Toxicology accompanied by 10-15 years in the drug development, pharmacology and regulatory toxicology experience in the pharmaceutical industry. Must have direct experience in managing and building successful teams and possess strong knowledge of the pharmaceutical/biological industry on drug development, manufacturing, and licensure . In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.

 

THE COMPANY

 

Emergent BioSolutions is dedicated to one simple mission—to protect and enhance life.

As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats.

 

We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.

 

THE OPPORTUNITY

 

Reporting to the Director, Preclinical Research, Pharmacology/Toxicology scientist is a vital member of the preclinical research team responsible for Toxicology/ pharmacology/ Pharmacokinetic studies in animal models conducted under GLP/non-GLP and regulatory requirements for drug development. The responsibilities include study design, dosage selection, study initiation and monitoring, data review, PK modelling and simulation, study reports and regulatory submissions. The scientist also conducts safety assessments for excipients, impurities, and extractable & leachable and provides overall direction, training, coaching, and mentoring to the preclinical team to support departmental and organizational objectives. 

 

DUTIES & RESPONSIBILITIES

 

  • Provides both strategic and scientific expertise for preclinical drug development for the areas of Toxicology/Pharmacology and Pharmacokinetic, ADMEK studies
  • Reviews medical and scientific literature to support the design, executes, and manages animal studies for safety, toxicity. PK, ADMEK and efficacy evaluation in support of clinical development
  • Develop study protocols, data analysis, present study results both internally and external stakeholders; liaise with other vital functional units (clinical research, project management, regulatory and assay) on the preclinical programs
  • Ensures compliance of DMPK & Safety development projects with external and internal quality requirements (GLP, ICH guidelines, SOPs) as well as adherence to Animal Welfare requirements
  • Provides comprehensive safety assessments for active ingredients, excipients, impurities in line with international standards
  • Establishes and maintains relationships with key opinion leaders and experts, academic institutions, and contract research organizations
  • Participates in professional organizations; kept abreast of recent research, new emerging technologies, for data management, toxicology, pharmacology, medicine, and regulatory laws
  • Interact with Biostatisticians in designing studies and analysis of data
  • Prepares submission-ready documents to various regulatory authorities
  • Uses sound judgment to resolve problems and make routine and advanced decisions independently
  • Oversees development of preclinical plans/cost and schedule for preclinical sections in support of Emergent responses to external RFPs
  • Leads, trains and mentors scientific staff as needed 
  • Assists with management decisions and activities
  • Model core values and support organizational objectives
  • Travel may be required for this position both domestically and internationally      

 

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.

 

EDUCATION, EXPERIENCE & SKILLS:

 

  • Candidates must have at minimum a Ph.D. degree in Biological Sciences, preferably in Pharmacology/Toxicology, accompanied by 10-15 years’ in the drug development, pharmacology and regulatory toxicology experience in the pharmaceutical industry
  • Toxicology Board certification is desired
  • Direct experience in managing successful teams is required to communicate goals, motivate team members, overcome obstacles
  • Demonstrate competence in building high performing teams
  • Excellent written and verbal communication skills are required
  • Applicants should possess strong knowledge of the pharmaceutical/biological industry on drug development, manufacturing, and licensure
  • Must have extensive knowledge and understanding of ICH and regulatory requirements for drug development/manufacturing and licensure
  • Working knowledge of GLP and cGMP regulations for drug development
  • Must have the ability to set and achieve results within budget and timeline specifications.
  • Excellent organizational, analytical, leadership, problem-solving, written/verbal communication, computer and interpersonal skills required
  • Experience in the document preparations for regulatory submission including eCTD summaries, IND/CTA
  • Working knowledge of word processing (MS Word), spreadsheets (MS Excel) and project management (MS Project) software will be considered advantageous.    

 

ADDITIONAL REQUIREMENTS:

 

  • Citizenship/Permanent Resident or Valid Work Permit.
  • Successful Completion of a Criminal Record Check
  • Medical assessment required upon hire      

 

Interested? Please visit www.emergentbiosolutions.com under the career section to apply today!

 

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.