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Job type: Permanent

Discipline: Analytical Chemistry, Biochemistry, Laboratory Technician

Location: United States

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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