Senior Engineer, Drug Product Technology Transfer
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. Technical Development are hiring a Sr Engineer with the following duties:
Senior Engineer, Drug Product Technology Transfer - Cork or Dublin
Hybrid role
Duties
- Lead the technical delivery of new product introductions and tech transfer projects by closely collaborating with cross-functional project teams, ensuring compliance with specifications, regulatory guidelines, and right-first-time delivery.
- Act as the technical SME for drug product (DP) filling operations, working in a matrix team environment with process development, QA, QC, analytical sciences, packaging, supply chain, and regulatory teams to achieve project objectives.
- lead DP partner team comprising of various cross functional members, for overall process development, scale-up and PPQ manufacturing activities, including regulatory filing.
- Support aseptic filling operations (vials and pre-filled syringes) for technology transfers and life cycle management, overseeing new product introductions from development batches to approval and commercialization.
- Lead process comparisons, risk assessments, manage DP technical and manufacturing risks and identify appropriate mitigations.
- Develop data driven strategies for process development/product characterization including pre-PPQ FMEA and/or NOR/PAR range finding efforts.
- Design experiments for lab studies/analytical work with a high level of autonomy.
- Author technical reports to support DP technology transfer and DP process and product characterization.
- Manage change control, deviations, and CAPAs through the quality management system until closure.
- Support on-site implementation of changes and DP launch activities.
- Facilitate investigations, root cause analysis for deviation resolution, data gathering/analysis, and provide technical assessments for deviations.
- Assist with PPQ campaign readiness and provide in-person, on-the-floor execution support for technical runs and PPQ campaigns as required.
- Initiate and lead process improvement projects, involving cross-functional teams.
- Author CMC sections of US and international regulatory dossiers, draft responses to the information requests during health agency review.
- Assist with regulatory inspections and present technical topics related to process aspects of assigned products when necessary.
- Assist in the development of global technical policies, standards, and guidelines for Drug Products as needed.
- Ensure a thorough understanding of all quality policies and BioMarin system items as outlined in the training curriculum.
- Other duties as assigned.
Skills
- Strong understanding and hands on experience in MSAT or process development or technology transfer, background in large scale processing of biologic drug products.
- Possess a strong understanding and hands-on experience in MSAT, process development, or technology transfer, with a background in large-scale processing of biologic drug products.
- Have a solid understanding of regulatory requirements and guidelines.
- Proficient in technical writing.
- Demonstrated ability to build strong partnerships and work effectively with diverse team members in a dynamic environment.
- Excellent organizational, interpersonal communication, and problem-solving skills.
- Capable of identifying, communicating, and implementing continuous process improvements.
- Ability to multi-task and manage tight timelines in a fast-paced environment.
- Able to work on the manufacturing floor for extended periods during the execution of technical protocols.
- Excellent written, verbal, and presentation communication skills.
- Strong analytical skills and sound judgment.
- Effective decision-making skills, with the ability to negotiate and balance decisions and priorities across multiple stakeholders' needs.
- Proficient in MS Office: Word, Excel, Outlook, PowerPoint, MS Project, etc.
Education and experience
- A degree in engineering or science with 8 years of relevant experience in the biotech/pharmaceutical field.
This role is based in Cork
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.