Method Development Scientist

Eurofins USA PSS Insourcing Solutions

Method Development Scientist

New Orleans, LA +1 location
Full Time
Paid
  • Responsibilities

    Job Description

    ** Responsibilities include, but are not limited to, the following** :

    · Perform non-routine analytical activities by independently developing and characterizing stability-indicating methods for early-phase pharmaceutical small to medium molecules with pre-set timelines using instrumentation such as, but not limited to, UPLC/HPLC, Dissolution, GC, Thermogravimetric DSC/TGA, and KF titration

    · Participate in technical discussions with project leads to recommend alternatives, research new methods/techniques and discuss potential solutions to problems.

    · Plan critical laboratory experiments to investigate aberrant results, determine root cause and recommend action plan

    · Write Standard Operating Procedures (SOPs), assist in generating technical reports, prepare data for presentations/technical discussions and transfer methods internally and externally

    · Prepare method protocols, & technical reports for characterization of analytical methods based on separation techniques (HPLC, UPLC, GC), Spectro-analytical technique (Ultraviolet-Visible Spectrophotometry), and dissolution testing

    · Assist and mentor junior-level scientists on analytical techniques and troubleshooting issues.

    · Ensure project deliverables are scientifically accurate and meet timeline expectations

    · Comply with all laboratory safety guidelines including Personal Protective Equipment (PPEs)

    · Maintain general cleanliness of the lab, including personal bench space and common use areas

    ** The ideal candidate would possess** :

    · Deep understanding of analytical sciences, drug development process, GMP/GLP requirements, and pharmaceutical industry trends

    · Previous experience in pharmaceutical oral solid dosage & parenteral drug product analytical testing

    · Good knowledge of three main pharmacopoeias (Japanese; JP, US; USP and European; Ph. Eur.) and ICH guidelines related to method development and validation

    · Experience in developing pharmaceutical small molecules analytical chemistry methods for dissolution multi-media screening and analyzing data using compendial methods

    · Understanding of experimentation and data analysis using Empower software

    · Excellent project management skills; Ability to communicate complex scientific findings/recommendations and project resource requirements (material, manpower, time, etc.), and elevate relevant issues to project lead and line-management

    · Excellent communication (oral and written), attention to detail, effective problem-solving and decision-making skills

    · Ability to work independently and as part of a team with internal and external clients, self‑motivation, adaptability, and a positive attitude

    · Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

    · Experience in exploration and application of innovative technologies/approaches to analytical development activities

    · Experience with transfer of analytical technologies

    · Ability to drive performance by tracking and managing key performance indicators using internal and external metrics

    · Ability to prioritize complex workloads and manage changing priorities

    · Proficiency in IT related skills such as Microsoft excel, word, PowerPoint etc

  • Qualifications

    Qualifications

    • Bachelor's degree in analytical chemistry, biochemistry, chemistry or other related degree concentration, or equivalent directly related experience (two years of directly related industry experience is equivalent to one full-time year of college in a related major)
    • At least ten years of related experience with separation science to support pharmaceutical oral solid dosage & parenteral drug product/substance analytical testing

    Additional Information

    Position is Monday-Friday 8:00am- 5:00pm Overtime as needed. Candidates currently living within a commutable distance of Indianapolis, IN are encouraged to apply.

    • Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
    • Life and disability insurance
    • 401(k) with company match
    • Paid vacation and holidays
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    • Authorization to work in the United States indefinitely without restriction or sponsorship

    Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

    Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

  • Locations
    Indianapolis, IN • New Orleans, LA