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PPD Scientist - Potency Bioassay , ELISA , FACS in Rockville, Maryland

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!  

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

Within the Analytical Development organization, the lab-based Scientist will be responsible for developing potency bioassays for support lot release, stability testing, and characterization of mRNA vaccine product development, according to Quality by Design principles in partnership with other Technical R&D functions, Quality Assurance, and Regulatory Affairs:

• Evaluate cutting-edge technologies and screen for suitable methods for new vaccine candidates

• Develop, optimize, and implement potency bioassays. Assay qualification and performance trending. Transfer potency assay methods to internal GMP testing groups, QC group, or CROs for vaccine lot release and stability testing

• Conduct characterization studies for better understanding of product quality attributes

• Collaborate with other functional groups, coordinate sample testing to support process development and formulation development

• Accurate capture of data in a timely manner, maintain laboratory notebooks, document experimental results under GSP (Good Scientific Practice)

• Design experiment, analyze and interpret data independently, present findings to the department and project teams

• Write standard operation protocols, study reports, relevant sections of regulatory filings, and scientific journal publications.

PPDFSP

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*Education and Experience: *

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification

  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years).

  • In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification

  • A thorough understanding and hands-on experiences with cell culture are required

  • Experiences in cell bases assays and immunoassays using flow cytometer and ELISA are required.

  • Familiarity with analytical development workstream is required

  • Problem-solving skills, attention to details, and good time management abilities are required

  • Cellular/molecular biology, immunology, or virology expertise is preferred

  • Experience with Luminex, HTRF, AlphaLisa , ELLISPOT, and High Content Imaging assays are preferred

  • Experience and knowledge working in vaccine research and development is preferred

  • Proven ability in technical writing skills

  • Ability to independently optimize analytical methods

  • Proven problem solving and troubleshooting abilities

  • Good written and oral communication skills

  • Time management and project management skills

  • Ability to work in a collaborative work environment with a team

*Working Environment:  *

/PPD values the health and well being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role: /

  • Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.   

  • Able to work upright and stationary and/or standing for typical working hours.  

  • Able to lift and move objects up to 25 pounds  

  • Able to work in non-traditional work environments.  

  • Able to use and learn standard office equipment and technology with proficiency.

  • May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. 

  • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.    

Job: *Labs

Organization: *US BU

Title: Scientist - Potency Bioassay , ELISA , FACS

Location: MD-Rockville-FSP Rockville MD

Requisition ID: 186388

PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group

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