Quality Control Analytical Technologies (QCAT) Analyst / Associate Scientist

Location:  Cork, Ireland Category: Quality

Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.



SUMMARY DESCRIPTION
We are a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. We are looking for an analyst with experience in separations (HPLC/UPLC and electrophoresis) and plate based methods (ELISA, etc) testing to join our team.
A high level of initiative, energy and motivation are key role requirements, as well as organizational skills.
Reporting to the Quality Control Analytical Technologies (QCAT) Team Lead, the primary role of the QCAT Analyst is to work with the QCAT team to execute method transfer, validation and verification protocols, troubleshoot methods, support method lifecycle management projects, and support analytical and process investigations.

 

SKILLS/ KNOWLEDGE/ BEHAVIOURS

The Quality Control Analyst/Associate Scientist will perform method development, validation, transfers, troubleshooting and testing of release and stability samples under direct or minimal supervision, compliant with cGMP guidelines. This position requires willingness to undergo training on more advanced analytical methods and employs laboratory safety polices always. Work assignments will encompass performing and documenting activities from routine to semi-routine in nature, and requires the ability to recognize deviations from the accepted practice. The analyst will be responsible for the timely completion of assignments. Good record keeping, organizational, written, and verbal communication skills are essential. The analyst must be willing to work overtime and weekends as required.

 

Performs, under direct or minimal supervision, molecular biological/physical/chemical analyses of test samples under cGMP to meet specified timelines.

Evaluates data against defined criteria/specifications.

Maintains the laboratory in an inspection-ready state.

Provides support for routine laboratory functions/chores for the QC laboratory.

Acts as a Product/Project Coordinator.

Interacts with other departments at BioMarin on a regular basis.

Develops and maintains proficiency in a broad range of trained test methods.

Assists in the revision of written procedures as assigned.

Assists in the preparation of routine and non-routine study protocols and reports.

Trains other analysts in areas of expertise.

Seeks, learns, and applies new job-related training and knowledge and shares knowledge with co-workers.

Holds self and others responsible to abide by department and company policies and practices. Is responsible for setting a good example for more junior analysts in the department.

Develops familiarity concerning cGMP, 21CFR, USP, EP and ICH regulatory requirements.

 

The Analyst/Associate Scientist will begin to apply his/her skills to non-routine samples which may include: process development and validation samples/studies. In addition, the support functions of the Analyst/Sr. Analyst position maintain the laboratory in a productive and compliant state, further optimizing the utilization of all personnel resources.

  

EDUCATION
B.Sc./B.A. in Science (major in biology-biochemistry-chemistry)

3-5 years of relevant laboratory experience

 

EXPERIENCE
• Ability to work independently and meeting established timelines.
• Comfort with coordinating the activities with other staff members. 
• Comfort with working in a team environment
• Knowledge of cGMP.
• Experience with HPLC and plate based assays. 

CONTACTS
Reports to Quality Control Analytical Technologies (QCAT) Team Leader. Interacts with several departments, including but not limited to Manufacturing, Quality Assurance, Regulatory Affairs, Maintenance, Engineering, and Manufacturing Sciences.

 

Note: This description is not intended to be all-inclusive or a limitation of the duties of the position.  It is intended to describe the general nature of the job that may include other duties as assumed or assigned.





We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.