Applied Protein Chemist for Biomarker Development

Location
Frederick, MD, USA
Posted
May 26, 2019
Ref
req476
Discipline
Science/R&D, Chemistry
Hotbed
BioCapital
Required Education
Doctorate/PHD/MD
Position Type
Full time
The Clinical Pharmacodynamic Program (CPP) is responsible for identification of biomarkers of response to new targeted agents entering clinical trials in the Developmental Therapeutics Program (DTP) and the Experimental Therapeutics Clinical Trials Network (ETCTN) of the National Cancer Institute (NCI). The CPP has recently been expanded to include support for the CTP immune-oncology program. The scope of work is broad and includes assay design, development, validation, fitness for purpose testing, transfer and support of assays in internal and external clinical laboratories, and clinical specimen analysis when required. PADIS, the assay implementation laboratory, is a fast-paced multi-disciplinary environment that applies state of the art quantitative immunoassays platforms to fulfill its mission.

KEY ROLES/RESPONSIBILITIES

The Scientific Project Manager II will help to establish and oversee a state-of-the-art protein chemistry laboratory focused on development and validation of conjugated antibodies used for clinical specimen analyses.

Specific responsibilities include:
  • Oversee and execute the development of novel antibodies using a variety of approaches such as mouse and rabbit hybridomas, and phage display including antigen design, immunization strategies, serum titer evaluations, cell fusions, scale up and antibody characterization in collaboration with scientific staff within the CPP program
  • Act as a technical project manager to establish and oversee subcontracts to custom antibody suppliers for the development, production and characterization of novel antibodies
  • Oversee and execute the characterization of antibodies, antibody conjugates and recombinant proteins using fit-for-purpose, current analytical techniques
  • Design and execute methods leading to the development of optimal protein bioconjugation procedures (fluorescent dyes, haptens, DNA barcodes) for antibodies in support of novel multiplex assay development
  • Facilitate process transfer and scale up of optimized bioconjugation processes with subcontractor
  • Recruit, train and supervise scientific staff in generation of materials and data necessary to support the primary experimental objectives of the program
  • Provide regular updates to program leaders through preparation of formal reports and presentations

BASIC QUALIFICATIONS
  • Possession of a Doctoral degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to protein chemistry, protein engineering, or related field in clinical diagnostics or medical imaging using antibodies. Foreign degrees must be evaluated for U.S. equivalency.
  • In addition to educational requirements, at least five (5) years of combined experience in protein analytical methods, protein bioconjugation methods and antibody development
  • Significant experience in the following areas: antibody design, development and characterization; optimized protein conjugation methods; current quantitative protein analytical methods
  • Collaborate with a diverse group of scientific staff responsible for development and validation of clinical pharmacodynamic assays across several platforms, internal critical reagent supply chain and incoming quality control testing and external subcontractors performing key aspects of reagent development and characterization.
  • Experience supervising laboratory staff from the entry level technician through Ph.D. level bench scientists
  • Hands-on experience with instrumentation
  • A record of publication in refereed scientific literature
  • Ability to maintain precise records
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS
  • Experience with one or more of the following techniques: Sandwich ELISA, Luminex assays, slide based multiplex immunofluorescence assay staining and analysis methods, immunoassay development, antibody conjugation and protein purification
  • Ability to independently develop, modify methods and techniques
  • Proficiency with Microsoft Office (Excel, Word, and PowerPoint)
  • Experience working in a GxP environment. Quantitative laboratory work in biochemistry, biology, chemistry, biotechnology
  • Experience in supervising laboratory staff from the entry technician level through Ph.D. level bench scientists
  • Outstanding English language communication skills are required. Ability to communicate with program lead researchers in a demanding scientific environment through preparation of formal reports and presentations
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)