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Principal Process Development Chemist

2 months ago

bensalem, United States Germer International - Pharmaceutical Recruiting Full time

Principal Process Development Chemist


Our client is a leading CDMO that specializes in the early development of bioconjugates. They are looking for an Principal Process Development Chemist to join their growing team that can manage the process development of APIs.


Company

A global CDMO focusing on cutting edge technologies in biologics for the treatment of types of cancer and central nervous system diseases.

Overview

This role will be a key role for the organization as they will be leading the Process Development organization on site. The professional should possess the ability to design and conduct research, troubleshoot, and solve problems arising during synthetic route/process development. They should also be able to develop safe and efficient synthetic processes that can be scaled-up reliably and reproducibly adhering to EHS and regulatory guidelines.

Responsibilities:

  • Leading a team in the development of new processes to manufacture Active Pharmaceutical Ingredient (API) for early development through Phase II clinical trials.
  • Ensuring that processes are suitable for controlling the quality of API as required by cGMP, ICH and FDA regulations as well as the attributes conducive to successful formulation development.
  • Managing the chemical process development, kilo-lab and pilot plant scale-up of API with contributions to broader CMC and regulatory activities.
  • Responsible for contributing to the planning of synthetic routes, the execution and of chemical synthesis projects.
  • The preparation, purification, and characterization of all materials, maintaining clear and current records of your work within a laboratory notebook, performing analytical work, attending and contributing to meetings, writing comprehensive reports and purchasing all necessary supplies and equipment.
  • Maintain a safe, pleasant, and efficient working environment.
  • Thorough documentation and authoring of SOPs, investigations, lab notebooks, batch records, deviations, CAPA and other relevant tech documents as applicable.
  • Follow safety procedures for organizational policies
  • Identify opportunities for improvement or optimization in current processes and implement viable solutions Investigate route modifications to limit cytotoxicity until the final step to reduce the cost of goods and increasing overall safety.
  • Exhibit detailed record-keeping, data analysis and chain of custody controls required in successful implementation of GMP.
  • Perform other duties as assigned.

Qualifications

  • This position required PhD degree in Organic Chemistry or Chemical Engineering and at least 8 work experience as process research and development chemist in an industry laboratory.
  • Experience with use of jacketed glass reactors up to 100 L
  • Experience with common process scale crystallization techniques
  • Experience with process scale medium-pressure and high-pressure chromatography development and scale-up
  • Experienced with process safety evaluations, i.e. thermal stability analysis
  • Knowledge and experience in a GMP environment preferred.
  • Knowledge and experience of analytical techniques and compound characterization.
  • Excellent oral and written communication/interpersonal skills; ability to speak clearly and persuasively in positive or negative situations with demonstrated leadership with both internal and external customers.
  • Strong capability in MS Office suite and working with electronic lab notebook systems (ELN). ERP system use is a plus.