21 days old

Specialist I, QC Bioanalytical

Emergent BioSolutions Inc.
Baltimore, MD 21202


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
Provide oversight of analytical or bioanalytical assay development and qualification /validation, performance of testing as required to support product release & stability or nonclinical/ clinical studies (GMP or GLP compliant) or product discovery, proof of concept studies, and candidate selection, and characterization of products and impurities to support process/product/formulation development, licensure, and product investigations.

 

ESSENTIAL FUNCTIONS

 Responsible for design, execution and documentation of analytical or bioanalytical assay development, transfer and qualification/ validation studies using spectroscopic, chromatographic, electrophoretic, immunological, in-vitro bioassay or related novel approaches, in collaboration with receiving lab and QA, to meet regulatory and ICH guidelines.
 Responsible for design, execution and documentation of bioanalytical studies for characterization of products and impurities to support process/product/formulation development, licensure, and product investigations.
 Responsible for execution, documentation and review of testing as required to support product release & stability or nonclinical/ clinical studies (GMP or GLP compliant) or product discovery, proof of concept studies, and candidate selection, and characterization of products and impurities to support process/product/formulation development, licensure, and product investigations.
 Coordinate daily schedule for lab staff and equipment to ensure that corporate and department objectives are completed efficiently within defined timelines. Reprioritize and adjust as required.
 Ensure that lab activities are conducted according to safety guidelines, policies and legislation.
 Maintain quality and quantity of departmental work through initial and continued training and oversight of lab staff; propose additional or customized training to lab management according to need.
 Perform administrative duties such as approval of time documentation. Assist in goal setting and performance review of lab staff.
 Provide technical and scientific assistance/expertise as required to clarify and troubleshoot scientific challenges internally or in collaboration with other departments.
 Provide information in support of department budget.  Contribute to departmental strategy and provide input on lab requirements and improvements.
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.

 

MINIMUM EDUCATION, EXPERIENCE, SKILLS
 University degree in chemistry, biology or related field of study.
 Minimum of five years directly related experience in a recognized professional or technical/scientific field, with a minimum of two years in a leadership role.
 Experience in a pharmaceutical cGMP environment is an asset, but is not required.
 Strong technical writing capability; can transfer ideas into scientifically sound and efficient study protocols and reports.
 Proficient and professional communicator, verbally and in writing.
 Demonstrated technical competence; can analyze data and interpret results to make scientifically valid conclusions.
 Strong organizational and interpersonal skills and the ability to work collaboratively with others.
 Proficient in complex procedures and problem solving.
 Strong commitment to teamwork, proven leadership skills, independence and initiative.
 Proficient in Microsoft Office - Word, Excel, PowerPoint
 Comprehensive knowledge of pharmaceutical GLPs and GMPs
 Comprehensive knowledge of laboratory techniques and safety precautions
 Comprehensive knowledge of WHMIS and biohazard safety
 Comprehensive knowledge of regulatory/industry guidance
 Experience with LIMS and SAP software applications is desired.


IV.  PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

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.

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

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

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<> .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

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 actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe 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.

Categories

Posted: 2020-12-31 Expires: 2021-02-07

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Specialist I, QC Bioanalytical

Emergent BioSolutions Inc.
Baltimore, MD 21202

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