Qc Expert In Atpm Modena

Qc Expert In Atpm
Modena
Emilia Romagna, Modena

Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients.

The Company's multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products.

Evotec leverages this "Data-driven R&D Autobahn to Cures" for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders.

Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e. g.

neurology, oncology, as well as metabolic and infectious diseases.

Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development.

Evotec operates globally with more than 4, 200 highly qualified people.

The Company's 16 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence.

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We have a great opportunity at our Medolla (MO) site for a QC expert in our site for Sterile GMP production of cell and gene therapies for clinical phases.

This position will be responsible for QC operations, ensuring company and intercompany ATMP development and manufacturing.

Essential Functions

- Manage all the activities of the Quality Control team overseeing day-to-day operations in the QC laboratory and leading QC personnel

- Provide technical and scientific support for the development, validation and execution of analytical and release testing methods (Biochemistry, Microbiological and Cell Culture test)

- Write and review Standard Operating Procedures

- Environmental monitoring, Personnel monitoring in manufacturing suites, Gowning and Aseptic Qualifications

- Support Change Control, CAPAs, OOS, Test Methods Reviews and Revisions activities

- Manage external contract workers, ensuring outsourced QC testing operations are performed as required and within the planned timeframe

- Produce, revise, review and approve technical reports and QC documents

- QC data collection and analysis

- Team player and willingness to cover other colleagues in continued support of the QC operations.

- Constant monitoring of quality control data, planning of periodic reviews and implementation of corrective actions against nonconformities.

- Plan team training programs supporting QC staff to ensure the efficient operation of the team

- Suggest and performs trouble shooting investigations and support activities for in-house tests

- Represent QC team at the Technical meetings presenting and discussing results

- Use strong cross functional skills to ensure proper communication with QA team and GMP manufacturing team

- Collaborates in the execution of internal Risk assessment documents

- Provide support in the manufacturing process validation, cleaning validation, process simulation

- Provide support to perform internal audits of GMP areas to measure compliance with appropriate procedures and applicable regulations

- Collaborates in the execution of internal Risk assessment documents;

- Promote and maintain a high level of GMP awareness and compliance in GMP areas.

Required Skills & Abilities

- Solid expertise in cytofluorimetry (data acquisition and analysis)

- Strong expertise in Biochemistry, Microbiological and Cell Culture methods

- Ability to analyze data, summarize results, and identify solutions

- Excellent knowledge of current GxP guidelines

- Positive, team player and problem-solving attitude

- Accurate, with excellent prioritization and organization skills

- Commitment to the assigned deadlines and ability to deliver them tightly

- English intermediate level is required (written and spoken).

- Good verbal, written, and interpersonal communication skills;

- Ability to work independently, maintaining a team-focused attitude;

- Open-minded and problem-solving attitude.

Education

- Degree in Biology/Biotechnology or equivalent; PhD preferred.

Experience

- Relevant experience in a Quality Control role (5+ years) in a pharmaceutical or biotechnology industry

- Previous supervisory experience in Quality Control preferred

- Experience in sterile drugs, particularly ATMP

Worker