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Senior Scientist - Multiple Opportunities Available in Gaith

Company: The Smithers Group
Location: Gaithersburg
Posted on: February 25, 2021

Job Description:

If you are a job seeker with a disability and require a reasonable accommodation to apply for one of our jobs, you will find the contact information to request the appropriate accommodation by visiting the following page: Senior Scientist - Multiple Opportunities Available in Gaithersburg, MD and Ewing, NJ Pharmaceutical Development Services, Gaithersburg
Gaithersburg, MD, USA
Smithers PDS LLC (Pharmaceutical Development Services) offers a comprehensive range of pre-clinical and clinical services for all phases of drug development, including support for development of drug delivery devices, and medical and pharmaceutical packaging testing. Our expert scientists perform large molecule bioanalysis, assay development, validation, and sample analysis at our GLP, GCP, and CLIA compliant laboratories. This is an exciting time to join our team as we grow and expand our Gaithersburg, MD and our newly open Ewing, NJ laboratories. Our senior staff averages 15+--years of experience in method development and method validation of PK/TK assays, anti-drug antibody assays (ADA),--neutralizing antibody (NAb) and other cell-based assays as well as fit-for-purpose biomarker assays. Many of our subject matter experts have been involved in clinical trial studies that have--led to the approval of biologics by regulatory agencies.--Our extensive experience with assays for both pre-clinical applications and all phases of clinical development, phase I through phase IV, has well positioned us for significant growth at both our Gaithersburg, MD and our newly operational Ewing, NJ laboratories.-- All of our instrumentation is connected to our Watson 7.4 LIMS system for QC and data security.-- Our assay services include the following:

  • Method Development
  • Method Transfer
  • Method Optimization
  • Method Validation
  • Sample Analysis Supporting:
    • Biologics
    • Monoclonal/Polyclonal Antibodies
    • CAR-T/TCR
    • Bi-Specific Antibodies We are seeking talented Scientists to join our team. We have several opportunities available ranging from Associate Research Scientist to Principal Scientist. Levels Position Summary and Minimum Qualifications Associate Research Scientist Summary:-- This role independently performs various assays according to SOP with reliability, applying and meeting GLP, GCP, and/or CLIA requirements, along with data analysis. Ensures lab, materials, and equipment are maintained. Minimum Qualifications:
      • BS/BA in biology, life sciences, or chemistry field and at least 3 years experience in immunological assay development; or
      • MS in biology, life sciences, or chemistry field and 1 year experience in immunological assay development;-- or
      • PhD in biology, life sciences, or chemistry field and experience in immunological assay development;
      • Prior CRO and GLP, GCP, and/or CLIA experience preferred;
      • Ability to assist with training and provide technical guidance to more junior scientists as needed;
      • Experience in PK, ADA, and Bioassays;--
      • Experience with troubleshooting; and
      • Experience supporting or leading development and validation studies. Research Scientist Summary: This role independently and proficiently performs BioPharmaceutical services tasks that maintains the integrity of the data and meets the regulatory --- GLP, GCP, and/or CLIA , protocol, and SOP requirements. This role mentors and guides new or more junior scientists. In addition, this role performs analysis including method transfer, supports or leads development and validation testing in support of GLP, GCP, and/or CLIA-- studies; provides analytical reports/report summaries and raw data summaries for studies; and may represent Smithers to clients, customers as well as outside service providers as necessary. Minimum Qualifications:
        • BS/BA in biology, life sciences, or chemistry field and at least 5 years experience in immunological assay development;-- or
        • MS in biology, life sciences, or chemistry field and 4 years experience in immunological assay development; or--
        • PhD in biology, life sciences, or chemistry field and 2 years experience in immunological assay development;
        • Prior CRO and GLP, GCP, and/or CLIA-- experience;
        • Able to assist with training and providing technical guidance to more junior scientists as needed;
        • Experience in PK, ADA, and Bioassays;--
        • Experience with troubleshooting; and
        • Experience supporting or leading development and validation studies. Senior Research Scientist Summary:-- This role independently and proficiently performs BioPharmaceutical services tasks that maintains the integrity of the data and meets the regulatory- GLP, GCP, and/or CLIA , protocol, and SOP requirements. It provides oversight, guidance and direction to new or more junior scientists and-- monitors lab performance regularly to-- ensure consistency in training and execution of a variety of techniques. Performs complex analysis including method transfer, development and validation testing in support of GLP, GCP, and/or CLIA studies. This role provides analytical reports/report summaries and raw data summaries for studies. In addition, this role represents Smithers to clients, customers as well as outside service providers as necessary. Minimum Qualifications:
          • BS/BA in biology, life sciences, or chemistry field and at least 10 years experience in immunological assay development;-- or--
          • MS in biology, life sciences, or chemistry field and 7 years experience in immunological assay development; or
          • PhD in biology, life sciences, or chemistry field and 4 years experience in immunological assay development;
          • 1-3 years prior GLP, GCP, and/or CLIA, and CRO experience;
          • Prior supervisory or lab management experience;
          • Ability to mentor and provide technical direction/guidance to others;
          • Knowledgeable with MSD and various ELISA preferred formats; and
          • Experience in PK, ADA, and Bioassay development and validation. Principal Scientist Summary:-- This role is responsible for the overall technical performance and project management to meet study deliverables that meet quality standards as well as timelines and budget parameters. It regularly interacts with clients and establishes herself/himself as Scientific SME to positively position Smithers for potential add-on / future business. This role is a significant contributor in the development of proposals and ably partners across teams and at all levels of the organization to ensure targets for client deliverables are achieved. Provides scientific/technical direction and oversight to assay development, method development, validation, and/or troubleshooting. This role provides scientific direction, guidance, and leadership to developing scientist and others in support functions. This position may or may not have direct reports. Minimum Qualifications:
            • MS in biology, life sciences, or chemistry field and at least 10 years experience in immunological assay development;-- or--
            • PhD in biology, life sciences, or chemistry field and 7 years experience in immunological assay development
            • 3 or more years CRO and GLP, GCP, and/or CLIA experience;
            • 3 or more years supervisory experience; Ability to lead/influence others; Familiar with MSD and various ELISA preferred formats; Experience in PK, ADA, and Bioassay development and validation
            • Strong publication record preferred Additional Responsibilities and Requirements applicable to all positions include: Corporate Responsibilities:
              • A dherence to laboratory health and safety procedures.
              • Adherence to Standard Operating Procedures (SOPs).
              • Adherence to applicable company policies and guidelines.
              • Adherence to federal and/or local regulations, as applicable.
              • Ensures appropriate reporting when there is reason to believe compliance with regulations, policies, guidelines, SOPs, quality, or other criteria are not being observed or enforced.
              • Ensure materials and equipment are maintained. Standard Requirements:
                • Excellent oral and written communication skills.
                • Proficient in advanced computer applications including MS Word, Excel, statistical programs and Watson LIMS database.
                • Able to work independently and manage priorities, as well as operate a team member.--
                • Must be solution oriented and open to input.
                • Must be able to comfortably and successfully operate in a dynamic environment with shifting priorities.
                • Must be able to collaborate and partner at all levels of the organization to accomplish deliverables and meet quality standards. Travel Required Yes . Occasional travel may be required. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Keywords: The Smithers Group, Washington DC , Senior Scientist - Multiple Opportunities Available in Gaith, Other , Gaithersburg, DC

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