Method Development Scientist

Published
October 7, 2020
Location
Indianapolis, IN
Category
Job Type

Description

Eurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment and pharmaceutical products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the USA.
Group's key figures are approx. 3 billion Euros turnover, 400 laboratories across 44 countries and more than 35.000 staff.

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 Equipments (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

Basic Minimum 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 related major)

•       At least ten years related experience with separation science to support pharmaceutical oral solid dosage & parenteral drug product/substance analytical testing

•       Authorization to work in the United States indefinitely without restriction or sponsorship

Additional Information

Position is full-time, Monday-Friday, 8:00 a.m.-5:00 p.m., with overtime as needed.  Candidates currently living in a commutable distance to Indianapolis, IN are encouraged to apply.

What we Offer:

  • 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

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

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