Director, Technical Operations
12 hours ago
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
The Director, Technical Operations is responsible for management and oversight of Technical Operations process strategy, CMO and CDMO management, and execution of product deliverables in alignment with Azurity policies, Azurity clients and in accordance with company objectives. The position leads staff and / or contractors and collaborates cross-functionally to achieve project milestones. The Director must possess a strong technical knowledge of drug product development, technology transfer, process validation, and commercial manufacturing, preferably demonstrated with previous drug development and commercialization experience. This position reports to the Vice President, Technical Operations.
Requirements
* Manage the planning and execution of manufacturing along with associated qualification and validation activities as they relate to both development and commercial products.
* In cooperation with contract facilities, manage the review, approval, and execution of controlled documentation concerning late-stage development, qualification, validation, and commercial manufacturing activities as needed.
* Direct tasks associated with product / process development (as applicable), product transfers, equipment qualifications, and validation activities to ensure alignment with company policies and objectives.
* Support and / or lead product launch and commercialization efforts.
* Ensure that appropriate policies, SOPs and documentation are in place to support validation practices according to regulatory requirements and applicable industry guidance documents.
* Support Management Review and Compliance related activities as needed. Assist in preparing metrics and compiling summaries to effectively communicate status and recommendations to Senior Management.
* Support Due Diligence activities to support company objectives including product development, technical transfer, commercial manufacturing, and/or commercial launch.
* Collaborate closely with cross-functional team members from functions including Supply Chain, Product Development, Quality Assurance, and Regulatory Affairs.
* Assist and advise other departments as required. Provide recommendations and input regarding departmental policies, procedures, goals and objectives; make judgments and decisions in a sound logical manner.
* Possibility of up to 40% travel, both domestic and international
Experience Required
* Hard Skills
* Bachelor’s degree in Life Sciences (Master’s Degree preferred), or related field.
* Minimum 15 years of experience in biopharmaceutical/pharmaceutical GMP environment or related industry.
* Expertise in cGMPs, ICH and Validation related requirements and guidances
* In-depth experience in performing technical transfer of multiple dosage forms (solid oral, liquid oral, injectables, etc.)
* Experienced in multiple validation disciplines including manufacturing process validation of multiple dosage forms, cleaning validation, packaging validation, analytical methods validation, terminal sterilization validation, hold time studies, shipping studies, equipment / utilities qualification, and facilities validation
* Ability to work in a strategic, tactical, and hands-on level.
* Candidate must be proficient in Microsoft Word, Excel, and Powerpoint.
* Experienced in participating in regulatory agency inspections.
* Soft Skills
* Strong organizational, interpersonal and communication skills to plan and accomplish goals
* Team oriented approach to project management and problem resolution.
* Ability to organize and prioritize project objectives for multiple products / projects.
* Ability to supervise direct reports and setting of personal development objectives.
* Interact with all levels of the organization and with current partners (and potential partners)
* Strong analytical and problem-solving skills
#J-18808-Ljbffr
-
Technical Operations Project Director
2 days ago
Dublin, Ireland Technical Concept GmbH Full timeAmicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases. Position Summary The Director of Technical Projects will be a highly motivated individual ready to work within a Technical Operations group consisting of...
-
Director of Operations
12 hours ago
Dublin, Ireland LINCOLN RECRUITMENT Full timeDirector of Operations Location: Dublin, Ireland About the Role A global leader in specialised equipment distribution is seeking a Director of Operations to join its management team. A new role within the business this role will ensure world-class operational efficiency, compliance with international regulations, and alignment with industry quality...
-
Director, Technical Services Dublin
3 days ago
Dublin, Ireland MongoDB Full timeThe worldwide data management software market is massive. According to IDC, the worldwide database software market was forecasted to be approximately $82 billion in 2023, growing to approximately $137 billion in 2027, representing a 14% compound annual growth rate. At MongoDB, we are transforming industries and empowering developers to build amazing apps...
-
▷ Apply in 3 Minutes! Director, Technical Services
21 hours ago
Dublin, Ireland INNOVATIONS BUILDING SERVICES LLC Full timeThe worldwide data management software market is massive (According to IDC, the worldwide database software market, which it refers to as the database management systems software market, was forecasted to be approximately $82 billion in 2023 growing to approximately $137 billion in 2027. This represents a 14% compound annual growth rate). At MongoDB we are...
-
Senior Director of Operational Intelligence
15 hours ago
Dublin, Ireland Archer Recruitment Full timeSenior Director of Operational Intelligence Analytics/ Engineering Director of Operational Intelligence opportunity in Dublin City Centre. This company is is a Global household name and have serious aspirations to reach a higher level of excellence. This Director of Operational Intelligence is a Senior critical role within the organisation. You will be...
-
Associate Director Quality Operations
3 days ago
Dublin, Ireland Grifols, S.A Full timeWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...
-
Director, Regulatory Operations
3 days ago
Dublin, Ireland ICON Clinical Research Limited Full timeDirector, Regulatory Operations ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Director, Regulatory Operations to join...
-
▷ Urgent Search! Civil Engineer
2 days ago
Dublin, Ireland Vickerstock UK Full timeCivil Engineer (Associate / Technical Director) | Dublin Vickerstock are delighted to be working alongside a leading consultancy to support in the recruitment of a Civil Engineer at Associate / Technical Director level to take the position of "Office-Lead" for their recently established Dublin (Dublin 2) office. Since their inception in 2011, the business...
-
QA Director
22 hours ago
Dublin, Ireland Amgen Full timeQA Director - ADL1 Plant Quality Assurance and Plant Technical Quality Assurance (PTQA) Join Amgen's Mission of Serving Patients What if you could join a company where every challenge is an opportunity to excel, and every opportunity is seized to make a lasting impact on the lives of patients? What if you could do this at an established facility that can...
-
Director
16 hours ago
Dublin, Ireland Has Wealth Management and Insurance Solutions Full timeThis executive role requires an exceptional leader with a strong track record of delivering large-scale infrastructure projects. The successful Director will work closely with the engineering team, contractors, public authorities, and the executive team to ensure projects are delivered on time and within budget. Desired Candidate Profile: 1. Risk...
-
Operations Director
3 days ago
Dublin, Ireland Concern Worldwide Full timeC3 2021 Job Title: Operations Director - Surge Team Reports to: Head of Emergency Operations & relevant Country Director Terms: 2-year Full Time Fixed Term Contract Unaccompanied.8 weeks annual leave increasing to 10 weeks after completion of first full year and R&R where applicable. Up to 3 weeks home-based work. All Surge Team members must be available to...
-
▷ [15h Left] Operations Director – Asset Manager
21 hours ago
Dublin, Ireland HOMESTEAD PROPERTY MANAGEMENT SERVI Full timeMy client, a leading Asset Manager based in Dublin city Centre, is now seeking an Operations Director to lead their Dublin operations. The director will be responsible for managing funds’ lifecycles, transaction oversight, and vendor management. Responsibilities: 1. Oversight of all trade lifecycle activities across trade execution, middle office,...
-
Managing Director
2 days ago
Dublin, Ireland Osborne Recruitment Full timeManaging Director Executive Opportunity Osborne Executive Search is delighted to partner with a leading international organisation in the advanced industrial solutions sector to identify their next Managing Director for the Irish subsidiary. This role presents a rare opportunity to lead a well-established and dynamic business during an exciting phase of...
-
▷ Only 24h Left: Director of Facilities
3 days ago
Dublin, Ireland Adecco Ireland Full timeWe are currently seeking a highly qualified Director of Facilities & Operations to join our client's team based in Dublin. As the Director of Facilities & Operations, you will be responsible for leading a team focused on delivering quality services to support the success of our client's businesses. This includes overseeing operational risk management,...
-
Director, Indirect Tax
3 days ago
Dublin, Ireland Brightwater Full timeIndirect Tax Director On behalf of a big 4 Indirect Tax team, were seeking an experienced Director or Senior Manager with either strong experience in financial services work or an eagerness to pivot into Financial servcies and become a top specialist. Due to their consistent growth across the firm and Financial Services tax division, they offer a high...
-
Managing Director
1 day ago
Dublin, Ireland Osborne Full timeManaging Director – Executive Opportunity Osborne Executive Search is delighted to partner with a leading international organisation in the advanced industrial solutions sector to identify their next Managing Director for the Irish subsidiary. This role presents a rare opportunity to lead a well-established and dynamic business during an exciting phase of...
-
(3 Days Left) QA Director
16 hours ago
Dublin, Ireland Amgen Full timeQA Director - ADL2 Drug Product Operations Join Amgen's Mission of Serving Patients What if you could join a company where every challenge is an opportunity to excel, and every opportunity is seized to make a lasting impact on the lives of patients? What if you could do this at an established facility who is expanding providing you with the opportunity to...
-
Project / Programme Director (Ireland)
3 days ago
Dublin, Ireland HOMESTEAD PROPERTY MANAGEMENT SERVI Full timeAround the world, SYSTRA’s specialists plan, design, integrate, test, commission, project manage and deliver mass transit and mobility solutions that are relied on by more than 50 million people every day. For more than 60 years, the Group has been committed to helping cities and regions contribute to their development by creating, improving, and...
-
Technical IT Manager
3 days ago
Dublin, Ireland Guidant Global Full timeTechnical IT Manager - Infrastructure Solutions Salary Level = €85-90K - No other benefits, apart from paid holidays & contributory pension. International Outsourcing Services Multinational is seeking a specialist within its Technology Solutions / IT Operations Services Division, to be based primarily on-site in a demanding public-sector client site in...
-
Dublin, Galway, Cork, Ireland RPS Group Full timeAt RPS, our Mechanical & Electrical engineering business is experiencing strong exciting growth, and we are now recruiting for a Senior Associate / Technical Director to help manage and grow our M&E Department, ideally based in our Dublin office, but not essential as we can be flexible for the right candidate. In this role, you will be an integral part of...