Method Development Scientist

Responsibilities include but are not limited to the following:

       Perform nonroutine analytical activities by independently developing and characterizing stabilityindicating methods for earlyphase pharmaceutical small to medium molecules with preset 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) Spectroanalytical technique (UltravioletVisible Spectrophotometry) and dissolution testing

       Assist and mentor juniorlevel 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 multimedia 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 linemanagement

       Excellent communication (oral and written) attention to detail effective problemsolving and decisionmaking skills

       Ability to work independently and as part of a team with internal and external clients selfmotivation 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 :

• Bachelors 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 fulltime 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

Remote Work :

No

Employment Type :

Fulltime