Scientist (Synthetic Chemistry)

• This role will focus on late stage small molecule commercial products.
• Looking for experience in small molecule analytical techniques (HPLC, UPLC, GC), sample prep, and wet chemistry. A background in synthetic chemistry is ideal.
• Lab based role, but a lot can be done remotely. This candidate needs to be able to come on site as needed. Hybrid as it as 2-3 days a week onsite, but there may be weeks where they won’t come onsite, and then weeks where they’ll be onsite full time.
• Will be providing data analysis as well as support to Reg affairs for submissions.
• Since these are commercial products, most method development/validation has already been done, but there are times when they may need to make method changes, and they want to internalize that function. So there may be opportunities to assist in new method development.
• NEED to have small molecule (AKA synthetic) experience. Would consider someone who has both large and small molecules exp.
• Would like to have 2 years of relevant experience.
• Top 3 Must Have Skill Sets:
• Generate, analyze, and critically evaluate analytical data to support investigations and regulatory submissions
• Author and review technical reports and sections of regulatory filings.
• Support process and method lifecycle management, including testing to support method remediation, qualification and transfer as well as process improvements and new product introduction

Our client's Commercial Attribute Sciences department is responsible for commercial analytical support, including method validation, method transfer, method remediation, method investigation support, process and product development as well as manufacturing and QC support.

The Scientist will work closely with a team of analytical chemists, organic chemists, engineers and formulators responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes for manufacturing processes and products.

The Scientist will integrate and successfully utilize platform and prior product knowledge to advance company practices and ensure success of the commercial and clinical portfolio.

Basic Qualifications

• 2 Years w/ Relevant MS or equivalent 4 Years w/ Relevant BS or equivalent Advanced and proficient understanding and use of technical principles, theories, and concepts to perform expansive range of work in a role.
• Basic knowledge of related and adjacent disciplinary areas.
• Some prior experience in the pharmaceutical or biotech industry
• Understanding and hands-on experience in various analytical platforms applied to the analysis of small molecule pharmaceutical products such as HPLC and GC techniques
• Excellent written and oral communication skills for the timely and detail-oriented documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment
• Client orientation– establishes effective and responsive relationships with all clients; translates client requirements into work design; ensures value is delivered
• Ability to critically analyze and interrogate various analytical data sets to drive and influence the investigational process
• Knowledge of Spotfire, Smartsheet
• Experience in applying troubleshooting and investigation methodologies for problem solving. This includes technical support for nonconformance investigations and other commercial support activities.
• Experience in developing and implementing methods for in-process, process characterization, and release testing
• Innovation – positive approach to challenges; champions’ new ideas and initiatives
• Communication – establishes and maintains effective communication mechanisms; works well in teams
• Interpersonal skills – communicates effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood; works well in teams
• Active in external scientific community