Analyst III, QC Laboratory Services

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.

Job Summary 

Perform GMP compliant testing as required to support Raw Material testing, In-process, Finished Product Release & Stability, nonclinical / clinical studies, as well as assay or process validations.

Maintain laboratory documentation and perform preventative maintenance and calibration on laboratory equipment per established procedures.

Author and ownership of investigations, deviations, critical reagent and standard qualifications, validation/verification protocols and reports, supplier qualifications, CAPAs and change controls.

Subject matter expert in defined areas of responsibility. Assist supervisor in lab scheduling and planning.

Responsibilities 

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

• Receive test samples, standards, chemicals, and reagents; maintain accurate laboratory records and inventory for all laboratory materials.

• Demonstrate a high degree of proficiency and independence when performing analytical test methods.

• Advanced proficiency in a wide variety of analytical/biological/Compendia methodologies and techniques with a clear understanding of regulatory requirements.

• Strong background in multiple analytical techniques chemical, physical, immunological, microbiological and viral. Examples include but are not limited to:

• Spectroscopy (UV, IR, Ramen, etc)

• Wet lab techniques (protein concentration, Particles HIAC, Extractable volume, osmolality, etc.)

• Microbial counts, endotoxin, sterility

• DNA extraction, Cell Culture, qPCR, ELISA, immunoglobulin assays, etc.

• Report results and complete LIMS data entry in a timely manner. Perform peer review of QC data, review, and approval in LIMS.

• Adhere to all effective STM’s/SOPs and safety requirements and document laboratory work consistent with cGMP requirements.

• Perform preventative maintenance / calibration on laboratory equipment, demonstrate advanced proficiency, and perform training in their use and maintenance in accordance with established procedures.

• Execute critical reagent and standard qualification studies and independently write protocols/reports; review and provide feedback.

• Maintain a clean and sanitary work area in accordance with standard laboratory practice and procedures.

• Plan and execute experimental tasks, make detailed observations of experimental tasks and obtain and interpret experimental data with minimal guidance.

• Lead troubleshooting/laboratory investigation efforts. Identify patterns and trends, troubleshoot abnormalities, and investigate problems.

• Write clear and concise assay forms, TMDs, SOP’s, protocols, technical studies, and reports independently. Revise lab documentation including assay forms, test method documents, and standard operating procedures in accordance with document management procedures.

• Provide training and assistance to peers and junior staff in an effective manner.

• Execute development and validation studies and write protocols/reports; review and provide feedback.

• Identify opportunities for improvements within QC procedures and documentation.

• Perform tasks effectively and independently.

• Collaborate across functional areas to effectively resolve problems.

• Independently move projects forward; guide project progression through appropriate decision making.

• Other duties as assigned.

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 Requirement

• University degree or technical diploma in chemistry, biology, microbiology, or related field of study.

• Minimum five years of directly related experience in a recognized professional or technical/scientific field. Experience in a pharmaceutical cGMP environment is an asset.

• Proficient in Microsoft Office - Word, Excel, PowerPoint.

• Proficient understanding of pharmaceutical GMPs.

• Proficient understanding of regulatory guidance.

• Ability to work in a faced paced and highly regulated environment.

• Knowledge of laboratory techniques and safety precautions.

• WHMIS and biohazard safety awareness.

• Comprehensive knowledge of laboratory techniques and safety precautions.

• Able to multi-task and adapt to changing priorities.

• Competent in laboratory safety and generally-accepted lab practice, including maintaining adequate written laboratory records.

• Able to interpret analytical data to support research and development work.

• Able to contribute ideas/solutions to aid in troubleshooting and investigations.

• Have strong communication skills; ability to articulate effectively in both written and verbal forms.

• Have strong organizational and interpersonal skills and the ability to work collaboratively with others.

• Strong leadership capabilities, independence, and initiative.

• Able to work flexible hours or shifts.

• A pre-employment medical check is required to be a successful candidate for this position 

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

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.