Required experience

- Pharma GMPs main regulations knowledge with at least 8 years experience preferably in role of Manufacturing Science and Technology or Process Validation subject matter expert

- Experience in manufacturing of complex pharmaceutical forms such as aseptic process of drug product, lyophilized products, biological products

- Process Validation and Continuous Process Verification

- Filter Validation

- Single use manufacturing systems

- Aseptic Manufacturing and Media simulation study

- experience in Technology Transfer team (at least 3 years)

- Experience in project management in Technology Transfer projects or similar context

- Risk management

- Documentation Management (SOPs, Specification, Records)

- Deviations/Non-conformities management

- Data integrity

- use of statistical tools and software

Other Desired Experience:

- experience in biotechnology/ biosimilar products (Cell and gene therapy; Cell culture expansion, harvest, purification, formulation, fill and finish; Blood plasma fractionation and component purification)

- experience in solid oral pharmaceutical forms

- Product Quality review

- Developing Validation / Verification Master Plans

- Performing formal risk assessments / FMEA

- Change Control

- CAPA process

- Identifying Critical Attributes and Critical Process Parameters

- Commissioning and Qualification

- Developing User Requirements

- Schedule development and execution

- Establishing metrics and leading team to achieve performance goals

- Facilitating meetings

La selezione rispetta il principio delle pari opportunità (l. 903/77)

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