Group Leader Drug Product Development

2 weeks ago

London, United Kingdom Real Staffing Full time

**Group Leader (Drug Product Development)**

I am currently working alongside a global, well established Pharmaceuticals company who are branching into a range of new niches within the industry. One of these expansions is into the Biosimilars field and as such, we are looking for a Group Leader forDrug Product Development to join the team at their re-purposed Laboratories in North London.

Your purpose will be to lead drug product process development of specific biosimilar projects, conduct technology transfer, enable scale up for commercial manufacturing and process characterisation.

**Responsibilities**:

- Manage scientists [includes goal setting, understanding developmental needs, assigning responsibilities in the lab activities, critically assessing their performance and provide timely feedback].
- To strengthen the team to develop in depth understanding of novel formulation development, drug product process development, consistency batches, process improvement using QbD approach, process characterisation.
- Work in collaboration with Downstream Processing, Upstream Process Development and Analytical Development teams for completion of project goals.
- Well versed in device selection (pen, autoinjector and related devices) and related studies required for regulatory approval.
- Well versed with appropriate CTD sections for regulatory submissions.
- Ensure completion of the work as per the project timelines and priorities.

**Requirements**:

- PhD. in a related field and at least 5 years of relevant experience is required OR Master's degree in a related field (or equivalent experience) and at least 8 years of experience is required.
- Technical competence in Formulation Development / appropriate scientific discipline or technology.
- Direct management experience of technical staff.
- Experience in biosimilars development would be highly desirable.
- Cross training in purification and analytical area would be preferred.
- Good proficiency with Microsoft Office Packages e.g. Word, excel, PowerPoint.
- Excellent communication and interpersonal skills.

If this Group Leader (Drug Product Development) position in North London looks like it could be the next step in your Pharmaceuticals career, please get in touch ASAP

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England andWales

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