Principal Scientific Associate - Process Chemistry, GMP Operations - Kilo Lab
The Manufacturing Operations Principal Scientific Associate, Kilo Lab Chemist performs the synthesis of test article for GLP toxicology studies, cGMP manufacture of APIs for early clinical trials from first in human (FIH) through proof of concept (POC), synthesis of API for formulation development and tech transfer development batches. Manufacturing is performed R&D or cGMP in glass and Hastelloy reactors ranging from 10 to 250-L using traditional organic chemistries. Batch sizes range from several hundred grams up to 10 kg.
Key Duties and Responsibilities:
The responsibilities of this position may include, but are not limited to, the following:
Responsible for the safe, compliant and timely cGMP manufacture of APIs for early phase development projects.
Independently carry out development and scale-up activities for synthetically derived compounds, including raw materials, intermediates, and drug substances in support of cGLP or cGMP studies.
Key collaborators are Quality Assurance, Release and Stability Lab/Analytical Development, Facility Operations and Engineering, Process Safety, Environmental Health Safety and Sustainability (EHSS), and Materials Management.
Key customers are Process Chemistry and Engineering and Materials Sciences.
Clean and maintain Kilo Lab equipment.
Follow all SOPs and Wis and verbal instructions.
Ensure compliance with all applicable regulations and SOPs and maintain excellent laboratory records and supporting documentation.
Identify and troubleshoot problematic chemistry, scale-up and equipment issues.
Generate effective scientific hypotheses to pursue desired synthesis or manufacturing goals and set new experimental direction based on results.
Manage other Kilo Lab chemists.
Performs other duties as assigned.
Knowledge and Skills:
Ability to safely set up and perform kilo laboratory experiments
Ability to read and follow chemistry
Ability to read and understand synthetic chemistry journals and rightly apply to solving synthetic problems
Ability to set up Kilo laboratory and get chemistry going
Ability to understand cGMP manufacture and follow SOPs
Ability to communicate results verbally and written and to exchange technical/scientific information.
Able to work within a team and deliver within the team structure.
Ability to run reactions in a lab making and isolating organic compounds at kilo lab scale.
Education and Experience:
Bachelor's degree in relevant field
BS with 5+ years, or an MS with 2+ years of relevant work experience.
Hands on cGMP Kilo Lab or Pilot Plant manufacture.
Synthetic organic chemistry of small molecules.
API process development.
Demonstrated understanding of common Kilo Lab equipment, processing methodologies, and best practices.
Excellent verbal and written skills.
The ability to successfully interact and collaborate within an interdisciplinary scientific team environment comprised of organic, physical, and analytical chemists; chemical engineers, project team members; and manufacturing personnel.
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [Register to View]