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Senior Manager - External Manufacturing

Employer
NonStop Consulting
Location
Limerick
Salary
£70000 - £90000 per annum + Bonus + Relocation + Benefits
Closing date
Apr 10, 2019

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Sector
Science, Life Sciences, Cell and Molecular Biology
Contract Type
Employee
Hours
Full Time
Organization Type
Corporate

Job Details

A new role has come up with one of the best employers in Europe.

The company designs & develops its own drugs without the use of CMO's, CRO's or other companies, so you will be involved in the full drug life cycle, getting a 360 view on the drug development.


Summary:
The External Manufacturing Snr Manager has responsibility for the operation of clinical and commercial parenteral drug product manufacturing in the External Manufacturing Network. They coordinate all aspects of manufacturing operations including overseeing day-to-day operations, technology transfer, new technology introduction, issue resolution, relationship management and supply fulfilment at drug product manufacturing sites.

Essential Duties and Responsibilities include, but are not limited to:
Serve as the primary Company operations contact for select Drug Product manufacturing sites.
Oversee production on site, co-ordinate the activities at Drug Product manufacturing sites to meet the company's Supply requirements.
Liaison between the company's internal IOPS functions and functional groups at DP manufacturing sites or business partners.
Coordinated all DP Manufacturing operations at contract and/or business partner manufacturing sites, including but not limited to: scheduling of all batches, supply of materials, direct shipment of bulk and finished product at manufacturing site, track and monitor cycle times, technology transfer execution and providing any required associated reports and technical expertise.
Ensure the timely routing and review of all master manufacturing records (MRs), standard operations procedures (SOPs), tech transfer reports, validation master plans, and other documentation related to clinical and commercial drug product manufacturing at drug product manufacturing sites and/or business partners.
Provide regulatory filing supports (IND, BLA, MAA, etc.).
Maintain required training status on the company's specific work instructions and SOP's.
Lead sub-team in continuous process improvements, system/equipment implementation and/or strategy development.
Support all investigations which concern DP Manufacturing or associated shipping operations, when required.
Ensure product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers.
Travel to contract manufacturers or business partners, as required. Ability to travel up to 50%.


Experience and Required Skills: Education and Experience:
BS/BA in Life Sciences or a related field and 8 years of industry relevant work experience. Relevant experience may be substituted in lieu of educational requirement.
Aseptic Parenteral Filling operations or development experience.
Previous experience providing technical support and interacting with Contract Manufacturing organisations.
Good interpersonal, cross-cultural, communication, negotiation and problem solving skills
Good knowledge of industry practices and regulations (e.g. GxP, ISO, ICH, etc.) across multiple health authorities (e.g. FDA, IMB, etc.)
Project management (PMP or equivalent) qualification preferable.

Company

Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

Company info
Website

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