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senior Analytical Development Scientist

  • Location: South San Francisco, 94063
  • Salary: $80-90 per hour
  • Job Type:Contract

Posted 2 months ago

  • Sector: Biotech, Preclinical, Clinical
  • Contact: Mohammed Rashed
  • Contact Email: m.rashed@sciproglobal.com
  • Contact Phone: 4245023257
  • : https://www.linkedin.com/in/mohammed-rashed-a86b1723a/
  • Duration: 12 months
  • Start Date: Asap
  • Expiry Date: 28 February 2023
  • Job Ref: MRI212007

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Senior Analytical Development Scientist

12 month contract+extension/conversion (on-site South SF)

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We are partnering with a forefront clinical stage oncolytic biotech company aiming to target elusive frontiers and inhibit growth of cancerous bio-mechanic pathways. With multiple projects in various clinical stages, they are looking to expand their team and talent! We are looking to hire a qualified Senior Scientist who is passionate about creating an everlasting change within the oncology sector.

The Opportunity:

The Senior Analytical Development Scientist will play a crucial role as the project lead of process R&D within the CMC function. This position will oversee API research, development, and optimization processes. As well as scaling up manufacturing to support compound development and clinical programs.

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Responsibilities:

  • Oversee daily operations and provide analytical support for API, R&D, and manufacturing processes. Contribute to drug product manufacturing and cross functional team projects.

  • Work on analytical; development strategies for various clinical projects. Demonstrate technical expertise in analytical instruments and act as a reference for junior colleagues regarding Analytical development functions

  • Review and analyze data provided from contract partners (CDMOs/CTLs), Be able to prepare and draft study protocols, analytical reports, CMC regulatory documents.

  • Determine appropriate analytical methods and support/manage contract laboratory counterparts to perform analytical methods development, validation, transfer to assist development and manufacturing of API and drug conjugates.

Desired Qualifications

  • Ph.D. or M.S. in analytical chemistry, organic chemistry, or relate fields

  • 3+ years of relevant experience within analytical development highly preferred if experience is in supporting early phase drug development.

  • Superb communication and interpersonal skills with ability to interact well with researchers, scientists, contractors, investors, and staff at all levels.

  • Extensive experience in analytical method development using instruments (HPLC, UPLC, GC, cKF). In addition to working knowledge of regulatory submission guidelines. (IND,IMPD, NDA)

  • High levels of organization and attention to detail with outstanding analytical, documentation, and multi-tasking skills.

  • Comfortable with current ICH guidelines, GMP guidelines, and similar industry practices.

  • Passionate about creating a difference for those who combat cancer!