R&d Biopharm Sterile Manufacturing Parma Scientist

3 settimane fa

Parma, Italia GSK A tempo pieno

**Site Name**: Italy - Parma

**Posted Date**: Mar 22 2024

The R&D Clinical Supply Chain Sterile Operations Parma department is looking for a Scientist to support clinical manufacturing business growth at Global Supply Chain Parma.

The new team member will work on projects in cooperation with GSC Parma and R&D Project teams.

In GSK we create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage _Life at GSK | GSK_

**In this role, you will**
- Implement technical solutions to enable manufacturing of new drug products, with specific focus to single use assembly qualification.
- Coordinate and execute experimental trials to assess process development robustness prior to clinical manufacturing.
- Coordinate and supervise manufacturing activities of development and clinical batches.
- Transfer product and process information from R&D development teams to Parma Plant, evaluating manufacturing feasibility through impact assessment and coordinating supporting functions through SAP PL notification management.
- Coordinate issue of key documents supporting drug products manufacturing (Technical Agreement, Manufacturing Guide, MBR...).
- Coordinate receipt of R&D supplied ingredients and ensure smooth Parma QA approval.
- Ensure any process deviation is resolved and properly shared with R&D and provide appropriate documentation supporting clinical release to R&D QA.
- Coordinate drug product samples and clinical vials shipment to the agreed destination.
- Support New Product Introduction department with technical transfer activities to commercial facilities.

The role, thanks to a variety of tasks, ensures knowledge acquisition on multiple R&D functions (Product Development, QA, Supply Chain...) and interactions with several GSC Parma departments (Manufacturing Operations, QA, Regulatory, Validation, Micro and Chemical Labs, Import Export and Warehouse...).

**Why you?**:
**Basic Qualifications and Skills**:
**We are looking for professionals with these required skills to achieve our goals**:

- Master's degree in scientific disciplines (Chemical Engineering or Pharmaceutical Technology or equivalent).
- Advanced knowledge of Italian and English languages.
- Experience in the Pharma Industry, within technical functions (Engineering, Technical, MSAT, Validation)
- Experience in change control management process
- Basic knowledge of aseptically filled drug products manufacturing process and related GMPs.

**Preferred Qualifications & Skills**:
**Please note the following skills are not necessary, just preferred, if you do not have them, please still apply**:

- Knowledge of terminally sterilized drug products manufacturing process; single-use system technology and freeze-drying process and equipment.
- Project management experience.
- Problem-solving tools knowledge.
- Good attitudes to team working and interactions with international and multi-functional stakeholders.
- Excel advanced user.

**Closing Date for Applications - April 12, 2024**

Please take a copy of the Job Description, as this will not be available post closure of the advert.

**Why Us?**

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

**Important notice to Employm

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