Laboratory Services Manager

If you are a current Jazz employee please apply via the Internal Career site.
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families.
We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options.
We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology.
We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies.
Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries.
For more information, please visit www.jazzpharma.com and follow @JazzPharma on Twitter.
Brief Description: Jazz Pharmaceuticals is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families by developing life-changing medicines for people with serious diseases.
The Jazz Pharmaceuticals Athlone manufacturing and Development facility is an integrated pharmaceutical operation encompassing drug product manufacturing and packaging.
The site was built and licensed in 2016 and currently manufactures two commercial products.
The site also provides technical support to many products in development, clinical investigational medicinal products and commercial products manufactured in CMOs.
The site is extending the scope to further support multiple commercial products, clinical supplies as well as other manufacturing operations completed externally.
The Manager, Laboratory Services is responsible for the efficient and compliant day-to-day operations of the team - as well as positioning the Laboratory Services group to support broader organisational objectives and development project activities.
The manager will work closely with other leaders in Laboratory Services and cross-functionally to contribute to achieving the site and organisational goals.
Scheduling of activities, compliance and adherence to site metrics will be a key aspect of the role.
The role will also work closely with other Jazz manufacturing sites and key stakeholders across the Jazz network to support any analytical activities to aid supply of Jazz products to patients.
This will include support of regulatory submissions, development studies, testing, release and stability of materials and products manufactured on site; testing, release and stability of materials and products manufactured within the Jazz network.
The role requires oversight of outsourced activities where appropriate.
Essential Functions Establish a culture of customer centered service delivery committed to continuous improvement in the execution of all Quality and analytical activities to deliver a best in class, compliant, safe, efficient, and productive environment.
Operational management role within Laboratory Services function responsible for laboratory and analytical activities.
Direct Line management responsibility for a number of Laboratory Services personnel.
Maintaining a motivated, knowledgeable, agile and talent based laboratory team with people management responsibilities for a number of laboratory personnel.
Facilitate staff personnel career development to ensure staff engagement, aligned with overall corporate goals.
Scheduling of activities and adherence to site metrics will be a key aspect of the role; controlling testing lead times, cost and other key indicators (such as reliability, flexibility, quality).
Oversee execution of discreet projects, validations, transfers, verifications etc to ensure overall project schedule timelines are met.
Responsible for co-ordination of activities at contract testing labs; ensuring cost effective service as well as adherence to overall schedule and a high level of compliance (and right first time).
Working with engineering department and external partners, ensure that the periodic calibration and qualification programme for laboratory equipment is compliant and adhered to.
Monitor, evaluate and resolve issues related to day-to-day activities of operations (as part of the wider Quality function) with other site functions to assure performance to schedule.
Escalate and appropriately communicate to stakeholders including direct line management to ensure any issues are effectively communicated and also remediated in a timely manner.
Guidance on issues related to deviations or laboratory investigations.
Participate on cross functional teams for investigations and deviation support.
Responsible for management of controlled drugs, data integrity and general compliance within the laboratory.
Work as part of matrix teams comprising of analytical and/or operations personnel to execute projects in line with global commitments and site objectives.
Work closely with the on-site technical services laboratory and collaborate with on-site functions to deepen technical and scientific understanding of products and processes providing solutions to the wider Jazz network.
Provide personnel to support and drive activities as appropriate.
Establish/confirm specifications for raw materials, process parameters, process controls and equipment, finished products as appropriate.
Work closely with all leaders to monitor and where necessary implement improvement initiatives in line with continuous improvement philosophy.
Required Knowledge, Skills, and Abilities Highly flexible, works well in a team environment and has the necessary skills to organize, communicate, influence and lead the group and demonstrate capability in establishing working relationships at all levels (regardless of seniority).
Proven track record and demonstration of technical proficiency for resolving complex issues including technical writing to support regulatory filings and submissions.
Strong people management / leadership skills.
Leads by example.
Experience in external activities and contract organisations.
Good knowledge of Quality Management Systems along with FDA and EU regulations.
Demonstrated experience of technical writing of complex issues to support regulatory submissions and inspections.
Broad experience in analytical sciences and in particular method development/ optimization.
Experience of steering complex HPLC/ GC method troubleshooting and leading investigations/ complex deviations.
Demonstrates potential for technical proficiency, creativity, collaboration with others, and independent thought.
Strong teamwork skills, including ability to lead and drive performance of cross-functional teams.
Excellent written and verbal communication skills with ability to multi-task.
Foster a culture of high performance within the function ensuring that the team are led and developed effectively.
Through leading by example, foster a culture of innovation, pursuit of excellence, integrity, passion and collaboration within the team maximising the strength of the team to achieve site goals.
Required/Preferred Education and Licenses Advanced degree in Chemistry, Pharm.
Sci., Biochemistry, Engineering or related field, or equivalent combination of education and work-related experience required A minimum of 7 years direct experience in pharmaceutical/biotech industry.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation.
For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html .