Company:
Walker Cole International
Location: London
Closing Date: 17/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
MSAT Project Manager
Walker Cole are proud to be partnered with a global, speciality pharmaceutical company in their search for a MSAT Project Manager in the Manufacturing Science & Technology team.
The Role
The role will be responsible for providing technical expertise to support the development of new drug products, from preclinical commercialisation, as well as support for marketed products. Responsibilities will include:
Technical support for the maintenance of the existing product portfolio. Acting as the CMC Lead in cross functional project teams. Responsible for process and analytical development, and manufacture of API, drug product, and drug/device combinations. Responsible for managing relationships with CMOs/External manufacturers. Authoring and reviewing regulatory CMC modules in product dossiers.
Required experience
A proven track record in API / Drug product development / manufacture, and CMC project management Prior experience in managing CMOs/CROs and other external manufacturers based outside of the UK Experience in the development and manufacture of sterile, solid and/or liquid parenteral dosage forms
Core competencies
Excellent communication skills. A high level of organisation. Ability to work well alone, as well as part of a team.
Education
A degree in a life science subject would be an advantage.
CMC | Manufacturing | APIs | Hybrid | EU | Europe | UK | Post approval | Established Products | New Drug Development | Sterile Liquid | MSAT | Formulation | Analytical | Sterile | Aseptic | Active Pharmaceutical Ingredient | API | Drug Product | Formulation | Chemistry Manufacturing & Controls | Oral Solid Dose | OSD
The Role
The role will be responsible for providing technical expertise to support the development of new drug products, from preclinical commercialisation, as well as support for marketed products. Responsibilities will include:
Technical support for the maintenance of the existing product portfolio. Acting as the CMC Lead in cross functional project teams. Responsible for process and analytical development, and manufacture of API, drug product, and drug/device combinations. Responsible for managing relationships with CMOs/External manufacturers. Authoring and reviewing regulatory CMC modules in product dossiers.
Required experience
A proven track record in API / Drug product development / manufacture, and CMC project management Prior experience in managing CMOs/CROs and other external manufacturers based outside of the UK Experience in the development and manufacture of sterile, solid and/or liquid parenteral dosage forms
Core competencies
Excellent communication skills. A high level of organisation. Ability to work well alone, as well as part of a team.
Education
A degree in a life science subject would be an advantage.
CMC | Manufacturing | APIs | Hybrid | EU | Europe | UK | Post approval | Established Products | New Drug Development | Sterile Liquid | MSAT | Formulation | Analytical | Sterile | Aseptic | Active Pharmaceutical Ingredient | API | Drug Product | Formulation | Chemistry Manufacturing & Controls | Oral Solid Dose | OSD
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Walker Cole International
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