Scientist- Bioassay & Critical Reagents

Frederick, MD

Posted: 07/13/2022 Job Number: 21109937

Job Description

SCIENTIST- BIOASSAY & CRITICAL REAGENTS
FREDERICK, MD
Onsite Position.

Project Description:
  • The Scientist plays a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
  • This position is responsible for supporting commercial bioassay activities within Global Technical Operations analytical method transfer, validation, training, and trouble shooting.
  • This is a lab-based position.
  • You will be responsible for conducting or participating in technically fast paced projects within your specific area or field.
  • Responsible for performing and troubleshooting cell-based assays, while applying these methods to a broad range of late stage, phase 3 clinical and commercial bioassays in a GMP environment. Responsible for maintaining technical expertise on several analytical areas and instrumentation.
  • Maintaining up to date familiarity with applicable regulations and regulatory guidance associated with analytical method design/transfer/validation requirements.
  • Manage authoring, review and approval of all technical documents, qualification protocols, SOPs, reports, and Certificates of Analysis as well as the coordination of all labs work necessary to complete qualifications on time.
  • Author/Review sections of regulatory submissions related to critical reagents.
  • In alignment with department/company strategic initiatives, influence and implement technology upgrade and continuous process improvements to analytical testing.
  • Establish harmonized processes and best practice on various activities related to global critical reagents.

Required Skills:
  • At least four years of experience with B.S or 2 years with M.S. Working in the biopharmaceutical or related industry experience.
  • Experience with development and commercialization of cell-based assays and ELISAs.
  • Working knowledge of molecular based (PCR) assays preferred.
  • Experience working with stable cell line generation, flow cytometry, and BSL2 level biological agents.
  • Proficiency to utilize statistical software for design of experiments and dose-response curve analysis (PLA, JMP, DoE, SoftMax Pro, etc.).
  • Ability to apply critical thinking to solve problems and work independently.
  • Strong interpersonal and communication skills.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Angie: angie@alphaconsulting.Com

ALPHA' S REQUIREMENT #22-02129
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

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Angie Dawn

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