Senior Scientist

Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation.

SENIOR SCIENTIST

Aptuit, an EVOTEC Company, is a worldwide Pharmaceutical Organization, collaborating with all the major Pharma and Biotech companies in support of various drug discovery and development projects. To efficiently support current activities and needs, we are looking for a Senior Scientist to join our Analytical Sciences team in Verona. ​

Responsibilities:

• She/He will be expected to provide key contributions with ideas and expert advices to the various phases of drug development, from API to drug product formulation development/optimization for the analytical activities and the Physical properties characterizations.

• Develop and validate analytical methods for API (mainly small molecules) and drug products characterization (Solid orals/Liquid orals and inhalation dosage forms).

• Perform analytical testing according to standard operating procedures for batch release and stability studies (Assay/Imps by HPLC, Dissolutions) meeting the expected cGMP quality and agreed timelines.

• Contribute to the solid-state characterization of the APIs and the physical properties of the drug products and intermediates by a varierty of techniques such as : XRPD, DSC/TGA, DVS, SSA, PSD, Optical/Electronic Microscopy, MicroRaman Spectroscopy, True/Bulk/Envelope Density, Flowability).

• Exercise professional judgement to identify analytical issues and support the QA team, with key decisions, to drive the preliminary Laboratory Investigations and extended investigations related to the release and stability of the products;

• Generates high quality documents including methods, operating instructions, protocols, and reports.

• Give written/oral update/presentation to the customers as representative of the technical area of expertise;

• Support in setting preliminary specification for development stability study during the discussion with the Clients;

• Collaboration with all the personnel involved in the project activities (Clients, analytical team members, formulators, Scientific Project Leaders, Project Managers);

• Report out-of-specification data (OOS) and out-of-trend data to the Manager;

• Ensure the traceability of all the operations conducted according to cGMP.

Qualifications:

• Degree in Chemistry, Chemistry and Pharmaceutical Technology or similar. MS and/or PhD will be considered a plus;

• Good written and spoken English;

• Good knowledge of Microsoft Office applications;

• Good knowledge of cGMP guidelines;

• At least 5 years of work experience in the analytical sector all in Pharmaceutical companies and GMP environment;

• Strong background in chromatographic techniques (HPLC/UPLC/GC-MS);

• Proven theoretical and practical expertise in the most traditional material science technologies such as x-rays powder diffraction, thermal analysis, spectroscopy (Raman and IR), particle size distribution determination, dynamic vapour sorption, microscopy is required.

• Precise management of activities, Commitment to the assigned deadlines and ability to deliver tight deadlines;

• Good knowledge of Empower 3 software;

• Good interpersonal and teamwork skills, precision and flexibility;

• Good knowledge of the specific guidelines and relevant regulatory EP and USP monographs;

In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.