Process Development Specialist

Proclinical is currently recruiting for a Process Development Specialist with a pharmaceutical company located in North Chicago, IL.

Job Responsibilities:

• Support the process development of parenteral formulations with a focus on small molecule parenterals.
• Design and execute studies evaluating the stability (chemical & physical) of parenterals against solution conditions (pH, concentration, excipients, temperature, light, moisture, etc.) and physical stresses arising from manufacturing process conditions (freeze-thaw, mixing, filtration, filling), 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, crimping).
• Continuous thorough maintenance (mechanical, electrical) of process and laboratory development equipment and troubleshooting of equipment technical issues.
• Optimize laboratory operations for efficient use of time and resources.
• Build strong relationships with other functional units (e.g. S&T, combination products, Analytical Development) and supports / advise activities in collaboration with partners.
• Document experimental data thoroughly in lab documentation systems, generate 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 disciplines, 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, etc. for liquid drug products.
• Experienced in laboratory systems (ELN) preferred. Minimally extensive laboratory documentation required.
• Experience in Microsoft Office (Excel, Sharepoint, PowerPoint, and Word) required.

If you are having difficulty in applying or if you have any questions, please contact Nadine Rucci at 215-531-5281.

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.

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