Drug Product MSAT Senior Associate Scientist

Location:  Cork, Ireland Category: Manufacturing

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.

MSAT Drug Product Scientist

Role Summary

As part of establishing the sterile filling operation at the Shanbally facility, this role will play an important part in the start-up of the facility, by interfacing and developing a close working relationship between the manufacturing sciences lab the DP manufacturing. The role will focus initially on the creation and establishment of a defect library for visual inspection for vials and syringe formats. The person will be responsible for maintaining, extending and qualifying the library and for the training and qualification of visual inspectors.  The role will contribute to process understanding, manufacturing best practices for filling and isolator technology with focus on the continuous improvement, personal development, and demonstration of production techniques that will result in agile and compliant manufacture of Drug Product material for both clinical and commercial filling of the BioMarin biologics product portfolio.

Duties

The MSAT DP Scientist will work in a team environment to create and qualify a defect library for visual inspection to support DP manufacturing operations. They will interface and collaborate with manufacturing operations, external partners and the BioMarin global drug product network. The role will work collaboratively providing SME input to technical delivery of NPI and TT projects and on best practices across all areas of the drug product manufacturing process. The role will provide key SME input to the visual inspection process and will train personnel and provide manufacturing support in creating visual inspection defect sets. The role will manage the translation of actual and potential defects from inspection to the MSAT laboratory for further investigational analysis. The role may require SME support for start up activities requiring  ownership and investigation of deviations, leading and contributing to MSAT lab studies, support for validation and training, and liaising with other departments in the inspection process such as QAV, QC, Manufacturing and  QA.

 

Main areas of responsibility:

  • Create, establish and qualify the DP vial /syringe defect set in the MSAT laboratory
  • Train and qualify visual inspectors
  • Catalogue and grow the defect library
  • Establish the visual inspection process in collaboration with other departments as required.
  • Support and may lead investigations utilising the MSAT lab capability and external labs as required. This may require ownership of deviations and other documentation such as SOPs, reports.
  • Establish collaborations with external providers such as contract testing labs and consultants to support the establishment and maintenance of the defect library(s)
  • Help establish and expand manufacturing sciences capability to support DP manufacturing operations.
  • Support NPIs and Tech transfers by working collaboratively both internally and with external CMOs
  • Contribute to and lead, when appropriate, lab studies related to DP filling such as mixing studies, cleaning studies, filter integrity testing, extractable & leachable studies
  • Provide SME input to aseptic filling and visual inspection, including technical assistance and deviation investigation.
  • Identify and progress continuous improvements utilizing new processes, equipment or technology for the drug product facility.
  • Ensure areas of responsibility meet compliance standards and audit areas against standards - highlight any issues and work proactively with the area team and others to ensure resolution
  • Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
  • Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools
  • Develop, define scope, and support the implementation of technical solutions under the guidance of site change control systems
  • Accountable for data integrity and scientific conclusions from assigned scientific projects
  • Accountable for assigned laboratory equipment use and maintenance

 

 Experience / Skills

  • Demonstrated experience working with DP visual inspection and defect library creation and maintenance is highly desirable.
  • Previous experience of vial and syringe sterile filling and visual inspection in a start-up environment is desirable
  • Lab analytical skills are desirable, with emphasis on bio-analytical skills and technical knowledge relating to particulate (visible and sub-visible) identification and characterization.
  • Demonstrated ability of excellent communication, demonstrated problem-solving skills and strong ability to interact across cross-functional teams.
  • Experience and proven track record to successfully influence team performance.
  • Expertise in planning and designing experimental work and in data analysis and interpretation
  • Aseptic drug product experience preferable.
  • Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results.


Education Required

  • Degree in Science / Engineering, or Industrial Engineering required
  • Other continuing education initiatives highly desirable (e.g., Six Sigma, Lean Manufacturing, industry specific coursework)


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.