Director, Drug Product Technology Transfer
7 hours ago
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations 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. Director - Drug ProductTechnology Transfer - Cork/Dublin/Remote Closing date 23January2024 Technical Development Services (TDS)are hiring fora Director of Drug Product Technology Transfer (Sterile)with the following remit. Provide technical and scientific leadership to the Drug Product Internal and External manufacturing networkthrough partnerships with global functions and third-party Commercial Manufacturing Organisation's (CMOs) to introduce new products and technologies. Provide technical leadership in onboarding new commercial assets across all modalities and ensure their successful integration into the BioMarin Operating Model. Accountable for the project execution and delivery of successful process characterisation, engineering, process performance and support to regulatory filing for drug product. Driving excellence in Tech Transfer execution for Sterile Drug Product. Project Portfolio Ownership. Drug ProductTechnology Transfer and Product LCM team are responsible for: Being the primary interface between GEO Manufacturing Operations, Internal Drug Product manufacturingandTDS for Technology Transfer and LCM. The delivery of Technology Transfer across the Global External Operations and internalManufacturing Network and successful handover to operations team. Development and implementation of Tech Transfer best practices and standardisation across theInternal and external manufacturing network. Supporting the development and execution of the Network Operations Strategy through Tech Transfer. Successful delivery of the product development pipeline and commercialisation strategy. The role will combine scientific, engineering, and operational leadership. This position requires a high degree of familiarity with cGMP and Quality Systems involved with commercial manufacturing processes. Duties: Leadership: Lead a team of scientists and engineers in the delivery of TT for Drug Product across our Global Manufacturing Network. Manage and communicate the project portfolio to key stakeholders. Identify, recruit, develop and retain qualified individuals to lead Tech Transfer. Experienced in authoring, reviewing, and coaching of staff in regulatory filing submissions. Create and maintain an environment of teamwork and collaboration while developing and motivating a high performing team that models the organisation values and attributes. Serve as an influential member of the Drug Product and Packaging Development leadership team, who impacts decision making and takes an active role in promoting initiatives, teamwork, and collaboration across functions. Partner with Drug Product and Packaging Development leadership to provide technical expertise and discussion during GMP audits from regulatory authorities. Ensure personal understanding of all quality policy/BioMarin system items that are per training curriculums. Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools. Participate in Global Partner Teams and CMC team as required. Skills: Experience in the Biopharma, experience in Process Development and MSAT/ Technical Development organizations is desirable. 10+ years of professional experience in the pharmaceutical industry, including managerial experience. Demonstrated to lead and develop an effective team of scientists and engineers. A broad understanding of Drug Productand a keen sense of business acumen. Experience collaborating effectively with other functional groups to achieve business objectives. Effective decision-making skills - ability to negotiate and balance decisions and priorities across needs of multiple stakeholders. Demonstrated initiative; results oriented, initiative to institute change. Exceptional communication skills required, with an ability to interact with and influence individuals and teams at all levels across the organization and global network. Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment. Education: Degree in Engineering, Science or Business Discipline PhD / master's in science or engineering Discipline is preferable. Location Ireland - Cork/Dublin/Remote Travel: 15-25% 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. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
-
Cork, Ireland BioMarin International Limited Full timeWho We Are 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...
-
Cork, Ireland BioMarin International Limited Full timeWho We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a...
-
Cork, Ireland BioMarin International Limited Full timeBioMarin 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,...
-
Cork, Ireland BioMarin International Limited Full timeBioMarin 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,...
-
Director/Associate Director, Regulatory CMC
3 days ago
Cork, Ireland BioMarin International Limited Full timeBioMarin 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,...
-
Cork, Ireland BioMarin International Limited Full timeBioMarin 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,...
-
Bioprocess Specialist
4 days ago
Cork, Ireland BioMarin International Limited Full timeBioMarin 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,...
-
Cork, Ireland BioMarin International Limited Full timeBioMarin 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,...
-
Cork, Ireland Life Science Recruitment Ltd Full timeSenior Director Statistics, Data and Analytics Our client, a global pharma company are adding to their statistics team and are currently recruiting for a Senior Director Statistics, Data and Analytics to join their talented team, on a permanent basis. People management experience is essential for this role. This role provides hybrid working....
-
Technical Development Scientist
4 days ago
Cork, Ireland BioMarin International Limited Full timeWho We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a...
-
Cork, Ireland Life Science Recruitment Ltd Full timeSenior Director Statistics, Data and Analytics Our client, a global pharma company are adding to their statistics team and are currently recruiting for a Senior Director Statistics, Data and Analytics to join their talented team, on a permanent basis. People management experience is essential for this role. This role provides hybrid working....
-
Supply Chain Analyst- Cork
24 hours ago
Cork, Ireland Claran Consultants Ltd Full timePosition Title: Associate Supply Chain and Master Data. Reporting to: Associate Director- Supply Chain and Customer Services Scope: Responsible for maintaining Toll Manufacturing Company (Toll) SAP master data and providing supply chain and master data support to Toll operations Comply with external regulations, policies, operating procedures and processes...
-
BioMarin International Limited | QA Associate
4 weeks ago
Cork, Ireland BioMarin International Limited Full timeWho We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a...
-
QA Associate
4 days ago
Cork, Ireland BioMarin International Limited Full timeWho We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a...
-
AD Chemist
1 month ago
Cork, Ireland Thermo Fisher Scientific Full timeWork ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionDiscover Impactful Work:The Analytical Development analyst will function as a key member of the Process Development Services Team. Our team liaise with our clients to introduce new products to the site and manage the process development, analytical development from clinical to commercial. This...
-
Audit Director Cork
4 days ago
Cork, Ireland Mazars Chartered Accountants Full timeAudit Director - Cork Forvis Mazars, the smart choice Forvis Mazars in Ireland is a leading professional services firm with ambitious growth plans and over 900 staff based in Dublin, Cork, Galway and Limerick. We are an integral part of Forvis Mazars Group, an internationally integrated partnership with over 50,000 professionals operating in over 100...
-
Director of Food
4 days ago
Cork, Ireland Broadline Recruiters - Permanent Full timePosition: Director of Food & Beverage Location: Cork Reports To: Director of Operations Position Overview: The Director of Food & Beverage is responsible for overseeing all aspects of the food and beverage operations within the hotel. This role includes strategic planning, operational management, staff supervision, and ensuring exceptional guest...
-
Product Test Engineer
2 months ago
Cork, Ireland Reperio Human Capital Full timeProduct Test Engineer (€30k-€40k DOE)Charleville, Cork, Ireland - HybridAs a Product Test Engineer, you should be conducting manual tests to ensure software created by the developers is fit for purpose. You should perform tests to ensure that the program functions properly, to identify any errors and to investigate customer complaints and any other...
-
MES Engineer
4 days ago
Cork, Ireland Cognizant Technology Solutions Ireland Full timeCognizant is looking for dedicated, innovative and driven talent to join our expanding team in Cork. We're currently looking for a full-timeMES Engineer, and the role comes with a generous salary and benefits package. As an MES Engineer, you will be responsible for implementing System/MES recipe changes and managing the day-to-day issues that arise in the...
-
Excelsys Technologies Ltd | Senior PCB Designer
4 weeks ago
Cork, Ireland Excelsys Technologies Ltd Full timeTitle: Senior PCB Designer ABOUT ADVANCED ENERGY Advanced Energy (Nasdaq: AEIS) is a global leader in the design and manufacturing of highly engineered, precision power conversion, measurement and control solutions for mission-critical applications and processes. AEs power solutions enable customer innovation in complex applications for a wide range of...
