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.
ANALYST II, QUALITY CONTROL LABORATORY SERVICES
13 MONTH TERM
Emergent BioSolutions is currently seeking an Analyst II for our Quality Control, Laboratory Services Department. The successful candidate will possess a university degree or technical diploma in chemistry, biology or in another related field of study, and a minimum of 2-4 years of directly related experience in a recognized professional or technical/scientific field. Must be proficient in Microsoft Office software, have knowledge of pharmaceutical GLP’s and GMP’s, regulatory guidance and laboratory techniques and safety precautions. In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.
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.
Perform cGMP compliant testing as required to support Raw Material testing, In-process, Finished Product Release & Stability or nonclinical / clinical studies, as well as assay or process validations.
Contribute to studies/reports in support of investigations, supplier qualifications, and validation/verification studies.
DUTIES & RESPONSIBILITIES
Receive test samples, standards and reagents.
Perform routine moderately complex QC analysis (e.g. ELISA, UPLC/HPLC, CGE, GC, Particulates) following written procedures and non-routine testing with supervisory guidance; report results and complete LIMS data entry in a timely manner.
Be familiar with a wide variety of analytical/biological/Compendia methodologies and techniques.
Perform detailed technical and data integrity review of QC data as required
Perform peer review of moderately complex QC data.
Adhere to all effective STM’s/SOPs and safety requirements and document laboratory work consistent with cGMP requirements.
Perform preventative maintenance / calibration on complex laboratory equipment in accordance with established procedures.
Write and execute critical reagent and standard qualification studies and maintain adequate inventory of supplies.
Make detailed observations during performance of experimental tasks; obtain and interpret experimental data with supervisory guidance.
Execute development and validation studies and contribute to protocols/reports.
Contribute to troubleshooting/laboratory investigation efforts with supervisory guidance.
Contribute to SOPs, protocols, technical studies, and reports under supervisory or senior analyst guidance.
Train and provide assistance in basic QC tasks to junior staff.
Identify opportunities for improvements within QC procedures and documentation.
Maintain laboratory records and inventory for supplies and reagents.
Maintain a clean and sanitary work area in accordance with standard laboratory practice and procedures.
Perform tasks effectively with minimal supervision.
Model the organizational core values through day-to-day actions
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:
University degree or technical diploma in chemistry, biology or related field of study.
Minimum two to four years of directly related experience in a recognized professional or technical/scientific field. Experience in a pharmaceutical cGMP environment is an asset, but is not required.
Proficient in Microsoft Office - Word, Excel, PowerPoint.
Knowledge of pharmaceutical GLPs and GMPs.
Knowledge of regulatory guidance.
Knowledge of laboratory techniques and safety precautions.
WHMIS and biohazard safety awareness.
Competent in laboratory safety and generally-accepted lab practice, including maintaining adequate written laboratory records.
Ability to work in a fast paced and highly regulated environment.
Able to multi-task and adapt to changing priorities.
Able to communicate and articulate information in both written and verbal forms.
Strong organizational and interpersonal skills; can work collaboratively with others.
Able to interpret analytical data to support research and development work.
Able to contribute ideas/solutions to aid in troubleshooting and investigations.
Citizenship/Permanent Resident or Valid Work Permit.
Successful Completion of a Criminal Record Check.
Medical assessment required.
Interested? Please visit www.emergentbiosolutions .com under the career section to apply today!