Method Development Scientist - Biologics

Organization
Covance
Job Location
Indianapolis, IN
Salary
Benefits
Job Description

METHOD DEVELOPMENT SCIENTIST - BIOLOGICS

Indianapolis, IN

We are looking to add a Method Development Scientist supporting our Biologics team at Covance. As a Scientist you will undertake original research that includes developing highly sensitive, reliable immunoassay methodologies for the rapid and accurate analysis of pharmaceuticals in biological fluids and tissues. Additional responsibilities include:

* Research and develop analytical methods for validation assays using a variety of analytical techniques for multidisciplined studies to generate results, solve problems, and interpret data of a scientific nature.

* Undertakes original research that includes developing and confirming highly sensitive, reliable assay methodologies for the rapid and accurate analysis of pharmaceuticals in biological fluids and tissues.

* Performs complex analytical methods on biological matrices, often involving problem solving situations.

* Proficiency in immunoassay techniques: (ligand binding assays, ELISA, MSD, Gyros, and/or RIA applicable to Pharmacokinetic and Immunogenicity studies

* Applies and interprets scientific theories, concepts, techniques, and regulatory requirements in bioanalytical and mass spectrometry studies and accepts leadership role in developing scientific approaches.

* Performing bacteriological analysis: Enumeration of bacterial load in challenge material and clinical samples.

* Performing virological analysis: Aseptic technique, Hands on experience in tissue/cell culture, growing viruses and quantification of virus, performing virus titrations, virus and serum neutralization assays.

* Preparation of bacterial stocks and other reagents for in vivo experiments. Clinical sample processing for bacterial load determination.

* Preparation of viral stocks and other reagents for in vivo experiments. Clinical sample processing for viral load determination by tissue culture or egg inoculation

* Preparation and handling various cell lines, tissue culture media and other reagents for virology work.

* Acts as research scientist, in a team work setting, for technical direction on complex large molecule bioanalysis projects.

* Apply and interpret scientific theories, concepts, techniques, and regulatory requirements in bioanalytical studies and accept a leadership role in developing scientific approaches

* Produce reports for reliable, sensitive, and validated methods of analyses..

* Provide technical/scientific guidance and leadership to the study team as well as other areas of the company to ensure project completion.

* Author scientific papers which are published in peer reviewed journals.

* Participate in client visits. .

At Covance, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance's impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities. In the role described below, you will have the opportunity to shape the evolution of a growing business. We are looking for a candidate with a thorough knowledge of the scientific field, who can collaborate with others and direct their own efforts with a drive to succeed.

Requirements:
The Required Education for the METHOD DEVELOPMENT SCIENTIST - BIOLOGICS includes:

Required Education:
* Ph.D in Chemistry, Biochemistry, Cellular Biology or related field with 1-2 years of industry experience.

* MS degree plus 8-10 years of related hands-on laboratory experience.

Experience The Required Experience for the METHOD DEVELOPMENT SCIENTIST - BIOLOGICS includes:

* Proven track record of immunoassay method development.

* The ideal candidate would have direct experience in the vaccine field

* Prior experience with commonly-used concepts, practices and procedures within the field of vaccines: e.g. viral and bacterial based vaccines.

* Prior hands on experience and knowledge of development in at least one of the following areas: Ligand-binding assays (ELISA / RIA / MSD / Gyros) and use of data reduction software. Experience with methods for evaluating immunogenicity is preferred.

* Skilled in conducting research, compiling data, data interpretation, and writing reports according to regulatory requirements.

* Skilled in performing scientific presentations and preparing scientific publications.

Highly Desired Experience:

* CRO experience.

* Experience with methods for evaluating immunogenicity is preferred.

* Prior experience working in a regulated GLP compliant environment.

* Hands on experience in one or more immunoassay techniques (Ligand-binding assay: ELISA, MSD, Biacore and/or RIA applicable to Pharmacokinetic and Immunogenicity studies.

* Hands on experience developing cell-based assays applicable to Pharmacokinetic and Immunogenicity studies.

* Experience developing and validating Immunogenicity (anti-drug antibody assays).

* Familiarity with FDA Bioanalytical method validation guidance, and industry guidance on Immunogenecity method validation.

* Prior hands on experience working with cell based assays as it relates to monoclonal assays.

* Knowledge of Laboratory Automation and Data Reduction Software (e.g. Softmax Pro, StatLIA etc) and LIMS systems (e.g. Watson)

* Experience with MSD or Electrochemiluminescent (ECL) Immunoassay.

We are looking for the best to lead the best. As one of the world's largest and most comprehensive drug development service companies, we respond to pharmaceutical and biotechnology clients' toughest drug development challenges. Covance has achieved impressive growth through our talented team's dedication to bringing the miracles of medicine to market.

EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran). Your confidentiality and privacy are important to us.

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About Our Organization

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