- Support process development/familiarization, scale-up and transfer of API processes into manufacturing including conducting hands-on laboratory experiments
- Work with internal teams and Commercial Manufacturing Organizations (CMOs) to deliver high-quality chemical processes for API delivery
- Play an active role in process troubleshooting and development of continuous process improvement projects
- Provide support for the development of first/second generation technology through collaboration with Research and Development.
Key objectives of this position include:
- Conduct laboratory experiments to generate technical data to support scale-up and implementation of API processes into manufacturing
- Collect and analyze technical data, generate reports including conclusions and recommendations where needed
- Apply QbD principles for identification and control of critical process parameters (CPP)
- Characterise and optimise chemical syntheses using a technical background in organic chemistry
- Participate in the scale-up and transfer of API processes at commercial scale
- Represent the receiving/sending site on API transfer teams
- Participate in troubleshooting and problem-solving activities across the manufacturing network promoting utilisation of the DMAIC process
- Serve on co-development teams and support transfer in of new chemical entities (NCEs).
- Develop and maintain relationships with colleagues within certain networks to identify potential value-creating opportunities for process improvement
- Comply with all safety and quality policies and requirements. Assure that the laboratories maintain a safe and clean working area. Follow cGMP procedures.
- Directly reports to the Process Development Lead Scientist or designee.
- Strong working relationship with all employees across all departments.
- All employees are expected to model our client's Core Beliefs. Each team member can influence and bring knowledge to their work and teams during their day-to-day interactions.
- This position will require fluent use of teleconferencing and WebEx tools, as well as SharePoint technologies, to share and manage information with internal teams, Commercial Manufacturing Organizations (CMOs) and Research and Development.
- BS degree in chemistry or chemical engineering is required
- Minimum of 5 years of process chemistry experience
- Mastery of scientific principles, practices and theories with process chemistry experience
- Familiarity with commercial-scale equipment and processes is required
- Demonstration of strong skills in organic chemistry
Please phone Gavin on 01-2302400 / firstname.lastname@example.org / www.rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.