Jazz Pharmaceuticals

Laboratory Chemist

IE-Roscommon-Athlone
3 weeks ago
ID
2017-1240
# of Openings
1
Category
Manufacturing

Overview

Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.


Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.


We are looking for the best and brightest talent to join our team.  If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals. 

Position Profile

The Laboratory Chemist  is a key member of the team responsible for analytical stability, raw materials, in-process and finished product testing ensuring efficient and compliant day to day operations. This person will also ensure that laboratory routine duties are performed to maintain a compliant laboratory displaying the highest level of GMP in their duties. In addition, they will support broader organisational objectives as required.

Key Responsilbiities 
  • Participate in transfer and validation of in-house methods and verification of compendial methods to ensure the overall project schedule timelines are met. 
  • Implementation and maintenance of laboratory specific SOPs and test procedures. 
  • Upkeep of calibration and qualification programme for laboratory equipment. 
  • Input to weekly work plans for smooth operation of the laboratory.
  • Execution and review of stability, raw materials, in-process and finished product work ensuring right first time KPI’s are achieved.Trending of stability, raw materials, in-process, finished product results including participation in out of specification/ out of trend investigations.
  • Assistance in the management of contract testing laboratories.
  • Monitoring, evaluating and resolving issues related to day-to-day activities of operations in coordination with Quality and other site functions to ensure performance to schedule.
  • Ensuring that all Quality Systems within the department are adhered to on a daily basis.
  • Trouble-shooting within the Laboratory Services Department and providing technical assistance / support to other Departments as required.
  • Liaise with external suppliers/vendors in relation to laboratory requirements.
  • Point of Contact for the Laboratory Services on inter departmental projects.
Key Attributes
  • Works well in a team environment with the necessary skills to organize, prioritize and execute key tasks effectively. 
  • Methodical, systematic and structured approach to execution of work.
  • Possess fundamental scientific thought process/ problem solving abilities and ability to follow up with corrective actions.
  • Generate documentation which is clear, concise and fully compliant. Ability to establish strong working relationships, build rapport and establish a cohesive team unit
Quality System Requirements
  • Good knowledge of quality systems, FDA and EU GMP regulations and ICH guidelines.
  • Proficiency in techniques and guidance related to raw material, finished product and stability testing using wet chemistry (pharmacopeia tests) and other techniques such as HPLC, GC, IC, KF, FTIR, NIR.
  • Ideally considered a SME in many of the above mentioned techniques.
  • Experience with biopharmaceutical methods desirable.
  • Experience with microbiological testing or working in a sterile manufacturing environment desirable.
  • Experience in implementation and maintenance of Operational Excellence principles.
Qualifications and Experience
  • BSc/MSc in science discipline required. 
  • Demonstrated technical expertise in multiple analytical techniques (particularly GC, IC, HPLC).
  • Experience working in a quality control environment (minimum of 3 years).
  • Proven track record of executing method validations and analytical product transfers. 
  • Participation in regulatory audits (IMB or FDA) desirable.

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