Sterile Manufacturing Specialist
2 weeks ago
We are seeking an experienced Sterile Manufacturing Specialist to join our team.
As a Sterile Manufacturing Specialist, you will be responsible for providing process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes.
You will also be responsible for providing technical support to biologics drug product manufacturing as part of the global Process Development organization.
Your main responsibilities will include:
- Leading new product introductions from a Process Development perspective.
- Providing technical support to biologics drug product manufacturing.
- Developing and implementing process validation plans.
- Ensuring compliance with cGMPs and other worldwide regulatory requirements.
Your duties will include:
- Development of process performance qualifications for vial and syringe filling.
- Collaboration with cross-functional teams to ensure successful product transfer projects.
- Technical evaluation of Change Control/NC/CAPA and technology transfer.
To be successful in this role, you will need:
- A strong background in process development, particularly in the area of biologics drug product manufacturing.
- Excellent communication and problem-solving skills.
- Knowledge of cGMPs and other worldwide regulatory requirements.
- Experience with process validation and tech transfer.
This is a minimum 12 month contract with the possibility of an extension.
The package includes core hours: 08:30 to 17:00.
Prepared to be onsite more regularly at the start to integrate into the team.
Requirement long-term to be onsite 3 days per week & come onsite when needed.
Shift Patterns: Once every quarter there is a need to support shift works is based on the support of PPQs and engineering runs.
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