Associate Scientist - Pharma

For a prestigious international company in the pharmaceutical sector, Randstad Italia is looking for an:

Associate Scientist

As Associate Scientist within the Global Parenterals Development Group, you are expected to manage and support project activities for parenteral dosage forms with a strong focus on formulation and process development for NBEs and Biosimilars using QbD principles.

Responsabilità

Main responsibilities:

- Design, execute and analyze studies related to formulation and process development, process characterization and tech transfer as well as in-house non-GMP manufacturing of biologics. Hands-on involvement in technical investigations, troubleshooting to support late-stage development.

- Act as scientific expert person for your assigned area of responsibility, participate to core project meetings, understands and proactively manages the interactions of project-related activities between the own function and other departments/sites (Manufacturing, Regulatory, Quality Control, Analytical Development, CMC Teams).

- Supports implementation of a sound formulation & process strategy including contingency planning and risk assessments as appropriate, in line with the overall project strategy. 

- Interpret and communicate results, evaluate data, draw relevant conclusions and write study protocols and reports in support of technical programs.

- Comply with quality standards and health and safety procedures, support innovation and improvement initiatives within the Department, foster strong team spirit and promote knowledge exchange within and between teams.

Professional background experience:

- Degree in Engineering, Chemistry, Biotechnology or Biology, CTF. PhD and/or specializations like Masters in Pharmaceutical Development highly desired.

- Minimum 2 – year experience in Drug Product Development of biopharmaceutical products (research and/or industrial environment). 

- Sound knowledge of formulation and process development of parenteral dosage forms. Familiarity with technology transfers, scale-up and optimization of processes. 

- Good theoretical and practical knowledge on techniques aimed at the characterization of physico-chemical state of proteins (e.g Chromatography, SDS-Page, Capillary Isoelectrofocusing Electrophoresis, particles counting by light obscuration or MFI). Additional theoretical and practical knowledge of testing methods for protein higher order structure analysis (e.g., circular dichroism (CD), infrared spectroscopy (FT-IR), fluorescence spectroscopy, DSC) and of techniques for fluidic characterization of solutions (rheology, density).

- Project management experience is a plus.

- Good knowledge of English, oral and written.

- Familiarity with statistics and statistical tools and proficiency in Office tools.

- Excellent time-management skills and good communication skills, experienced to work pro-actively to achieve given milestones and objectives. 

- Team player and experienced to work interactively with various stakeholder and under limited supervision.

We offer a temporary replacement for a Maternity Leave , full time contract.

Work area: Roma Est

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