Senior Research Fellow (Director)
Proclinical is currently recruiting for a Senior Research Fellow for a biopharmaceutical company located in Newark, California. Successful candidate will support route scouting and scale up of the current/future peptides in development pipeline. The candidate will be responsible for peptide process research, large scale laboratory production and process transfer to CMOs.
- Conduct laboratory scale experiments to identify routes for manufacturing of peptides and amino acids using both Solid and Solution Phase Peptide Synthesis.
- Demonstrate the process on large multigram scale in-house to support internal research as well as for outsourcing to partnering CMOs.
- Develop and execute manufacturing and supply strategies of raw materials, regulatory starting materials, and drug substance.
- Actively participate in the evaluation and selection of new third-party contractors and suppliers for process development and manufacturing activities.
- Work with CMOs in transitioning laboratory experiments to larger scale equipment for the manufacturing of Peptides on larger scale following GMP protocols.
- Work closely with analytical scientists to monitor and understand the impact of process changes on the yield and impurity profile of developmental of peptides.
- Contribute to Quality/CMC related regulatory correspondence.
- Effectively document both laboratory and scale up activities.
- Be creative and innovative problem solver.
Skills and Requirements:
- PhD in organic/peptide chemistry, with 7+ years, or MS in organic/peptide synthesis, with 10+ years, of process research and development experience.
- Experience with peptides chemistry and process development is a plus.
- Strong understanding of FDA/ICH/cGMP guidance.
- Demonstrated ability to effectively lead projects with internal and external resources.
- Strategic thinker and problem-solver capable of identifying risks and risk mitigation strategies.
- Strong teamwork, negotiation and influencing skills, able to work in a team setting and establish clear and consistent goals and objectives.
- Must be hands on, detailed oriented, self-driven and goal-oriented, and able to multi-task to achieve results.
- Must be able to adhere to strict project timelines and budgets advise teams and management on impacts and changes in project time-lines.
- "Out of the box" thinker, to take on calculated risks, and champion new ideas and approaches.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Hunter Tonn at (+1) 646-851-0086 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
A top 10 global pharmaceutical company is currently recruiting a Senior Scientist - Level 1.
Suzhou Shi, Jiangsu
A leading biopharma organisation is advertising a vacancy for a PD Director based in their office in Suzhou.
A leading pharmaceutical company is advertising a vacancy for a Director, Research & Development, based in their office in Reading.