Technical Scientific Affairs Manager
Pharmaceutical/Biotech
Sligo
Site Leadership role
The Technical and Scientific Affairs (TSA) Manager is a member of the Site Leadership Team and is responsible for executing the technical agenda of the site, including Technology Transfer, Process Validation, Cleaning Validation, Manufacturing Operations and were required Research and Development Activities.
You will be able to support Site Leadership peers at the Sligo Manufacturing Site to deliver an expanding and complex technical agenda.
This could be an ideal step up role for a senior scientist or process scientist looking to manage a small team of process/TSA scientist.
A masters coupled with a sound technical knowledge of process ( freeze dry and fermentation) , parentals and biologics is key. You will lead robust root cause analysis and provide guide the TSA team.
Responsibilities
- Lead, motivate and develop the TSA team that provides technical expertise and technical leadership for investigation and resolution of process deviations, root cause investigation, CAPAs, process improvements, review, and approval of change controls.
- Provide team leadership - setting work goals, controlling and meeting goals, professional and personal development of team members.
- Interaction with National Authorities when required
- Implementation of new production methods, Technology transfer: Examination of production methods prior to their transfer to production, including validation (when needed). Follow-up and training of production teams.
- Examining the development processes and adapting them to the registration requirements.
- Input to the leadership team and the ongoing development of the company strategy.
- Professional support for various subjects on demand.
- Participating in short and long-term organisational planning and strategy as a member of the management team.
- Participation in professional forums.
- Team management - setting work goals, controlling and meeting goals, professional and personal development of team members.
Education
- Minimum of a Masters degree in a technical discipline (e.g. biochemistry, chemistry, biotechnology, biopharmaceuticals).
Experience
- At least 8 years experience in the biotechnology and/or pharmaceutical industry, with experience of new product introductions and product support.
- At least 5years experience in People Leadership with direct and/or matrix reports.
- Knowledge of the processes and equipment necessary for the manufacture of pharmaceuticals (oral solid dose), parenterals and/or biologicals
- Experience with vaccines would be preferable particularly in the area of product development and stewardship.
- Ability to prioritize workload for self and reports to short and near term horizons.
- Ability to plan for long term horizons for technology, processes and people.
- Flexible and agile in support of the sites overall goal.
- Demonstrated ability in coaching and mentoring technical teams,
- Excellent problem solving (facilitation and application of tools), risk management and decision making skills.
- Excellent collaboration skills required.
- Proficient in written and spoken English.
For a confidential discussion , please reach out to [email protected]
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