Drug Product MSAT Interface AssociateLocation Cork, Ireland Apply
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.
The DP - MSAT Interface Associate will report to the Sr. Director Sterile DP Manufacturing Operations.
They will work in a team environment that will be committed to the establishment of the Shanbally drug product processes including the recombination process, sterile filtration, aseptic filling, visual inspection and its interface with manufacturing sciences. The role will contribute process understanding, manufacturing best practices, focus on the continuous improvement, personal development, and demonstration of production techniques that will result in agile and compliant manufacture of Drug Product material.
The DP-MSAT Interface Associate will work in a team environment to collaborate on best practices across all areas of the drug product manufacturing process including the recombination process, sterile filtration, aseptic filling, visual inspection. The role will provide key SME input to the aseptic filling and inspection process end to end. The DP-MSAT Interface Associate will train relevant personnel and provide manufacturing support in creating visual inspection defect sets and translate potential defects from inspection to the MSAT laboratory for further investigational analysis, The role may also require support for start up activities that may require ownership and investigation of deviations, support for validation and training and liasing with other departments in the inspection process such as QAV, QC, Manufacturing and QA.
Main areas of responsibility:
- Providing manufacturing support for the recombination processes for FBDS including best practices for filtration and yield optimization.
- Contributing to filter integrity testing practices onsite including pre and post testing of product filters.
- Provide Key SME input to aseptic filling including technical assistance and deviation investigation.
- To identify and progress continuous improvements utilizing new processes, equipment or technology for the drug product facility.
- Establish the visual inspection process and collaborate with other departments as required to identify the interfacing process for further investigation.
- Establish a defect library in the MSAT laboratory and support investigations of same. This may require ownership of deviations and other documentation such as SOP’s, reports.
- Help establish manufacturing sciences capability to support DP manufacturing operations.
- Ensure areas 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.
- Partner with validation subject matter experts, review/approve validation protocols, validation plans, protocol executions, and summary reports in support of ongoing revalidation and validation efforts required for commercial manufacturing.
- 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
- Demonstrated experience working with NPI processes in manufacturing environment.
- Experience and proven track record to successfully influence team performance.
- Aseptic drug product experience preferable.
- Strong demonstrated ability in communication and strong ability to interact across cross-functional teams.
- Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results.
- Experience with regulatory inspections.
Should be proficient in the operation of all equipment used in the respective functional area of responsibility.
- Degree in Science / Engineering, Operations Management, or Industrial Engineering required
- Other continuing education initiatives highly desirable (e.g., Six Sigma, Lean Manufacturing, industry specific coursework)
- At least 3 years of related experience in a regulated manufacturing environment with excellent knowledge of aseptic controls.
- Experience in drug product filling, packaging, and labelling beneficial
- Demonstrated ability to partner with other functional groups to achieve business objectives
- Strong knowledge of cGMPs (US & EU), OSHA, ISO, and other regulatory agency standards and requirements applicable to a pharmaceutical production facility.
- Experience of successfully contributing to a startup operation highly desirable
- Strong communication and interpersonal skills – Oral, written, and formal presentation skills
- Creative problem-solving skills
Leadership Behaviors and Personal Competencies:
- Builds partnerships and works collaboratively with others to meet shared objectives.
- Develops and delivers communications which convey a clear understanding of the unique needs of different audiences.
- Skilled influencer; able to distill complex concepts into concise, salient points.
- Holds self and others accountable to meet commitments by following through, acting with a clear sense of ownership, and taking personal responsibility for decisions, actions, and failures.
Drives Vision and Purpose
- Paints a compelling picture of the vision and strategy which motivates others to action.
- Credible, trustworthy and empathetic leader; calm under pressure; can do attitude; relates openly and comfortably with diverse groups of people.
Agility and Flexibility
- Handles multiple projects and priorities simultaneously; operates effectively, even when things are not certain or the way forward is unclear.
- Able to work in a variety of roles and settings, with a diverse group of people and/or functions.
- Able to prioritize and focus on the few critical objectives;
- Design simple, flexible organizational structures and systems that can align and adapt with evolving strategy.
High Ethical Standards and Integrity
- Effectively adjusts to new, changing and unpredictable situations; able to learn new things quickly and easily; solicits and responds to feedback and coaching.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
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.