Process Development Associate Scientist
Proclinical is currently recruiting for a Process Development Associate Scientist with a biopharmaceutical company located in North Chicago, IL. We are looking for a highly motivated person who supports and drives process development activities for NBEs. The candidate will maintain as well as improve our technological equipment to expend the state-of-the-art and support the development of manufacturing processes for biologics. Furthermore, the candidate will keep and increase the state of operational excellence of our lab. Working closely with analytical and formulation scientists in an integrated group the candidate will develop productive collaborations and communications with scientific and technical teams.
- Supporting the process development of parenteral formulations for biologics with a focus on antibody drug conjugates.
- Design and execute studies evaluating the stability (chemical & physical) of biologics against solution conditions (pH, ionic strength, temperature, light, moisture, etc.) and physical stresses arising from manufacturing process conditions (freeze thaw, mixing, filtration, filling, and lyophilization), and screen excipients (buffers, stabilizers, surfactants, etc.) to develop robust formulations for frozen, refrigerated liquid, and lyophilized dosage forms.
- Being the first point of contact for the operation of advanced NBE process technologies with special emphasis on process unit operation (filling, filtration, lyophilization)
- Continuous thorough maintenance (mechanical, electrical) of process and laboratory development equipment and troubleshooting of technical issues on the machines.
- Builds strong relationships to other functional units (e.g. S&T, combination products, Analytical Development) and supports / advices activities in collaboration with partners.
- Optimize laboratory operations for efficient use of time and resources.
- Document experimental data thoroughly in lab documentation systems, make concise scientific presentations of process results and author detailed scientific technical reports.
- Responsible for compliance with all applicable policies and procedures.
- Understand and adhere to corporate standards regarding code of conduct, safety, and GXP compliance.
Skills and Requirements:
- BS or MS in Chemistry, Pharmaceutical, biological, engineering, food science or related discipline with typically 4(BS) or 0-2 (MS) years of relevant experience. or significant technical / industrial experience in the technical field.
- Solid understanding of the various unit operations of aseptic manufacturing such as bulk freeze thaw, compounding/mixing, filtration, filling, and lyophilization for liquid and lyophilized NBEs.
- Experienced in laboratory systems (ELN) preferred.
- Experience in Microsoft Office (Excel, Sharepoint, PowerPoint, and Word) required.
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 contact Nikki Ranieri at 215-531-5288 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.