Sr Research Associate I, Process Development
With the commitment and drive you bring to the Pharmaceutical Development & Manufacturing (PDM) workplace, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.
This individual will assist, primarily from lab based activities, process chemistry activities for pharmaceutical APIs. These activities will include scale-down model development and qualification, process optimization, robustness studies, formal process characterization and risk assessments, and process validation. In addition, this individual will support process technology transfer activities, due diligence, and facility fit assessment for internal and external manufacturing facilities. The person will play an integral role as a process chemistry representative for global CMC project teams.
Specific Responsibilities & Skills for the Position:
- Responsible for developing chemical processes for the manufacturing of drug substances.
- Familiar with Pilot Plant operations and able to write master batch records and safety summaries with limited supervision.
- Plans and executes assigned experiments, with increasing independence, which supports Process Development activities and project goals.
- Executes reactions and makes key observations during reaction, work-up and isolation.
- Pays particular attention to avoiding reactions and processes that do not scale well, such as distilling to dryness and flash chromatography.
- Gains a better understanding of how impurities are formed, tracked and purged throughout the subsequent processing.
- Recommends alternatives, researches new methods and techniques and proactively seek out senior personnel to discuss potential solutions to problems
- Collaborates with supervisory personnel to develop strategy and tactics.
- Always works with safety in mind.
- Demonstrates and applies an advanced level of understanding project goals and methods.
- Uses good verbal communication skills and interpersonal skills to provide insight into the processes used to achieve experimental results.
- Demonstrates skills in data analysis (ex: UPLC, HPLC, NMR, mass spec) and ability to evaluate quality of data.
- Works with collaborative communication and problem solving spirit.
Typical Education and Experience:
- BS in Chemistry
- 2+ years of industry experience (medicinal/process preferred).
- MS degree - Chemistry (Organic Chemistry Focus).
Please Provide Research Summary with Application