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Position:
Senior Scientific Director, Bioanalytical Sciences

Employer:
Precision for Medicine

Description:

e part of a team of renowned scientific authorities delivering groundbreaking assay results using clinical specimens to accelerate drugs into the clinic.

In a landscape where dynamic change is the only constant, we help pharmaceutical and life sciences companies look beyond the boundaries of the present. We work as a team, spanning projects from molecule to medicine cabinet, anticipating incipient industry trends—then harnessing them.

We develop assays and handle global logistics, speeding to actionable answers. We use biomarkers to stratify patients using a companion diagnostics, improving R&D efficiency and success. We handle every aspect of clinical trials from sites to biomarkers to diagnostics, dramatically accelerating our clients' pathway from proof of concept to drug approval.

Precision’s specialty in vitro and ex vivo assays achieve a diversity of research, safety, efficacy, and biomarker objectives to speed and streamline our client's research and clinical trials. Our multiplatform immune monitoring solutions support preclinical through phase 3 studies, supported by our global biorepository footprint, cell biology, sample processing, and molecular capabilities. We deliver high quality meticulous sample handling and sophisticated global logistics—always utilizing industry-leading quality systems, including GxP, ISO 9001, ISO 13485, College of American Pathologists (CAP), and Clinical Laboratory Improvement Amendments (CLIA).

The Senior Scientific Director, Bioanalytical Sciences will use their scientific expertise to lead development and validation efforts for bioanalytical assays to support multiple dynamic clinical and non-clinical studies for clients engaged in ground breaking research.

How you will make a difference:

  • You will mentor and lead a research team consisting of Research Associates and Associate Scientists ensuring consistent scientific standards and compliance with Precision procedures and regulatory expectations on all projects
  • You will participate actively in the bioanalytical community to ensure Precision is fully aware of any and all relevant direction for regulated bioanalysis of biologics for PK, ADA, Nab, and biomarkers.
  • You will be the face to the client, managing expectations and overseeing the execution of all work to ensure the team is meeting study compliance for all work performed
  • You will be a scientific resource to clients and with internal teams on Product and Services/R&D related projects
  • You will trouble shoot and correct routine scientific issues, establish and improve all procedures and required SOP documentation
  • You will review data and provide written and verbal technical updates to clients
  • You will assist with writing, reviewing and editing contract and grant applications/proposals


Qualifications/Experience:

Qualifications:

Minimum Required:

  • Ph.D. in Immunology or related discipline
  • 10+ years’ experience beyond post-doctoral training (at least 4 years in industry)
  • Prior supervisory experience

Other Required:

  • Demonstrated expertise in bioanalytical assays including PK, ADA, and Nab and current regulatory guidance and industry standard methodology
  • A deep understanding of current GLP, GCP or GCLP standards
  • Working knowledge of CAP/CLIA and ISO 9001
  • Excellent communication, interpersonal, organizational and multi-tasking skills
  • Proficient with Microsoft Word, Excel, and PowerPoint
  • Ability to interact and function in a highly productive work environment
  • Ability to work independently and have good attention to detail
  • Ability to lift and carry between 1-15 lbs.; frequently required to sit, grasp, and use right/left finger dexterity; May be exposed to a cold freezer environment (Freezer temperatures range between -20ºC -196ºC)
  • Able to read, write, speak fluently and comprehend the English language
  • Preferred:
  • Direct experience working at a CRO, Biotechnology or Pharmaceutical company.
  • Expertise in ELISA, MSD, Luminex, and SPR technologies


Location: Redwood City, CA

Contact: Malinda Gain

Post Date: 3/7/2019 7:26:38 AM
┬ęPharmaceutical & BioScience Society, International; Last Modified: 5/29/2020; Admin Logon
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