Our client is a leading biopharmaceutical industry and is currently seeking an accomplished Senior Principal Scientist to join the team. Here is an overview of the role:
1) Provide engineering process development, technology transfer, and regulatory filing support for the development of robust, safe, and economical manufacturing processes for small molecule drug substance intermediates and APIs to internal and external API manufacturing facilities.
2) As a technology leader, will identify, develop, and apply existing and new chemical development technology to advance process understanding
3) On API project teams, apply chemical engineering principles (reaction kinetics, thermodynamics, heat and mass transfer, and mixing effects) to evaluate and develop scalable and robust processes for the manufacture of active drug substances.
4) Develops and applies new and existing process technologies to enable development and transfer of safe and scalable processes to API manufacturing facilities.
5) Designs and performs laboratory experiments to develop process understanding using DoE experimental methodology and automated laboratory instrumentation.
6) Performs experiments to understand reaction mechanisms and kinetics, stability, solvent exchange, etc.
7) Supports technology transfer of drug substance processes to internal API manufacturing facilities and external suppliers.
8) Serves as a key point of accountability for new product site registration and validation activities.
9) May spend significant time at the launch site supporting process validation and activities.
10) Applies chemical engineering skills and specific process knowledge to understand and resolve scale-up issues during transfer.
11) Contributes to the preparation of the CMC section of the NDA.
12) Participates in data verification and post submission query response
13) Champion the development of novel laboratory development instrumentation and software modeling tools to improve process understanding.
14) Leads the development and implementation of new and existing workflows and methodologies.
15) Remains current with the process engineering and chemistry literature.
16) Collaborates and prepared internal research reports and technical presentation.
17) May collaborate and author external publications and present research at external conferences.
More questions? Want to know the Salary range? Keep reading.
The best way to get more details is to click ‘Apply’, upload your resume, and ENTER YOUR QUESTIONS in the ‘Cover Letter’ field. A recruiter will call you and answer all of your questions (if they feel you are a fit for the role). Your resume will be kept CONFIDENTIAL – we respect your privacy. Our Recruiters are more likely to respond to your questions if they know you are *seriously* interested, and prefer to know a little bit about your background before calling.
1) Follow our CEO on Twitter for status-updates about your job application:http://www.twitter.com/sterlinghoffman
2) Add our CEO on Facebook:
We will try to respond to your questions privately via Twitter or Facebook only.
TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Healthcare, Life Sciences, Scientist, R&D, Clinical Research, Clinical Trial, Regulatory Affairs, Nutraceutical, Surgeon, MD, Hospital, Immunology, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility, Hospital, Research and Development, Medical Affairs, Drug Safety