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Scientific Affairs Associate

Employer
AmbioPharm, Inc.
Location
North Augusta, SC
Start date
Apr 20, 2022

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Discipline
Science/R&D, Bioanalytical Services, Chemistry, Research
Required Education
Masters Degree/MBA
Position Type
Full time
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  • Facilitate problem-solving and decision-making with respect to Scientific deliverables to meet timelines.
  • Facilitates timelines/tasks/requests from project teams and other cross-functional departments.
  • Focuses on proactive planning to manage risk, remove barriers, and meet goals.
  • Good understanding of drug product development and different characterization techniques.
  • Ensure smooth scientific transition of project from development phase to commercialization phase.
  • Manage outside and in-house analytical work for various projects.
  • Drafting protocols and specifications as required.
  • Communicates all pre-defined scientific events to team members.
  • Maintain accurate record of all scientific correspondence with partners, vendors, contract labs, CMOs, etc.
  • Schedule meetings and teleconferences as needed for resolving scientific issues.
  • Maintain project specific files such as characterization reports, etc.
  • Support internal departments with scientific issues when needed.
  • Work with functional managers to resolve scientific issues and escalate to higher management as needed.
  • Assist with preparation of Deficiency responses for Global regulatory filings (FDA, EU, PMDA, CFDA, etc.).
  • Retrieve, coordinate, and complete documents required by regulatory agencies and partners.
  • Responsible for creation of scientific strategies to support development and lifecycle of drug products in USA, Canada, Australia, EU, Japan, China, emerging countries, and ROW.

    • Qualifications:

    • PhD or MS in Analytical Chemistry (PhD is preferred)
    • Strong background in various analytical techniques such as Mass Spectrometry, NMR, SEC-UV, SV-AUC, FTIR, Far UV CD, etc.
    • Capable of writing scientific reports as required.
    • Ability to lead effective problem solving.
    • Able to identify issues requiring escalation.
    • Excellent organization skills
    • Strong computer operating skills including Microsoft Project/Gantt Charts
    • Detail oriented with multi-tasking abilities and ability to meet deadlines.
    • Seeks consensus but makes decisions.
    • Self-motivated, able to work in a team and independently.
    • In depth knowledge of Complex Generics is a plus
    • 5+ years experience in pharmaceutical environment is a plus.
    • Experience in Complex Generics and 505 (b) (2) is a plus.
    • Strong interpersonal and communication skills (written and verbal) for bridging across diverse cross functional, multi-national, geographically dispersed teams.

    ADA-These Requirements are a Condition of Employment:

    • Must be able to push, pull, squat, stand and walk through-out the day.
    • Must be able to lift up to 20lbs daily.
    • Must be able to wear safety shoes & glasses through-out the day while in designated areas. (provide by the company)
    • You must be cleared by a physician to wear a respirator throughout the day while in designated areas.
    • You must be able to work in a chemical environment.
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