A global biopharmaceutical firm seeks an Associate Director, API Process Engineering, to lead small-molecule API manufacturing processes. The role requires expertise in process engineering, particularly in a cGMP environment, and over 5 years of experience in the pharmaceutical sector. The candidate will enhance process control, optimize production strategies, and collaborate across multiple functions to ensure regulatory compliance and best practices. We offer a supportive and inclusive workplace dedicated to employee development. #J-18808-Ljbffr
Associate Director, API Process Engineering Join to apply to the Associate Director, API Process Engineering role at Takeda. About the role As Associate Director, API Process Engineering, you will be Takeda’s global expert for small‑molecule API manufacturing processes across batch and continuous platforms. You will apply chemical engineering and process chemistry fundamentals to design, scale, and control API processes from clinical development through commercial supply. Through the integration of mechanistic modelling, process simulation, and rigorous data analysis, you will deepen process understanding, strengthen control strategies, and support regulatory submissions for global markets. You will become the central hub for API process knowledge, driving best practices and continuous improvement across Takeda’s manufacturing network and external CMOs. How you will contribute Lead the Small Molecules API Manufacturing Sciences activities within Global Process Science, serving as expert for small‑molecule API processes and technologies. Provide process engineering support for batch and continuous API platforms from clinical through commercial stages, integrating process chemistry and engineering perspectives. Apply mechanistic modelling, process simulation, and quantitative analysis to enhance process understanding and enable robust process control. Lead API manufacturing process characterization, including risk assessments and definition of critical process parameters and controls. Lead technology transfer of API processes between internal sites and external CMOs, ensuring robust, reproducible, and compliant implementation. Lead API process validation activities, including strategy, protocol design, execution support, and data evaluation. Develop and implement strategies for continuous improvement of marketed API processes, including yield optimization, robustness improvements, cost of goods reduction, and capacity expansion. Establish and maintain systems and procedures for best practice in commercial technology transfer and process validation. Build and oversee a central knowledge base of API process and product understanding, ensuring lessons learned are shared across products, sites, and functions. Collaborate closely with GMS functions, site leadership, Technical Services, Pharmaceutical Sciences, Global Quality, and Regulatory CMC. Provide technical support to marketing applications for global markets and lead preparation of responses to regulatory questions from health authorities. Utilize structured root cause analysis techniques to investigate process and equipment issues and deliver robust, sustainable corrective and preventive actions. Provide subject matter expertise for due diligence in mergers and acquisitions and in‑licensing evaluations. What you bring to Takeda At least a Master’s degree in an area related to Chemical Engineering, Process Engineering, or Pharmaceutical Engineering. At least 5 years of experience in a cGMP manufacturing environment and at least 5 years of pharmaceutical industry experience in small‑molecule APIs (these may overlap). Strong foundation in organic/pharmaceutical chemistry and chemical engineering, with applied experience in API manufacturing processes. In‑depth understanding of pharmaceutical manufacturing processes, ICH guidelines, and current global regulatory requirements relevant to API processes. Demonstrated experience in mechanistic modelling, process simulation, and data‑driven process optimization. Proven track record leading API process characterization, technology transfer, process validation, and lifecycle changes in a multi‑site or global context. Strong problem‑solving, project management, and stakeholder management skills, including the ability to resolve conflicts and drive clear decisions in cross‑functional teams. Excellent written and verbal communication skills, including experience preparing high‑quality technical reports and presenting project results to diverse audiences. Ability to work independently and proactively while collaborating effectively within multi‑disciplinary teams (Engineering, Manufacturing Operations, Manufacturing Sciences, CMC teams, and others). Commitment to sharing knowledge across functions and sites and to building sustainable technical capabilities in the organization. Intellectual curiosity about technology and new ways of working, coupled with a collaborative and open mindset. Willingness to travel to international manufacturing sites and work side‑by‑side with site teams on highly complex issues. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best‑in‑class patient support programs. Takeda is a patient‑focused company that will inspire and empower you to grow through life‑changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Empowering our people to shine: Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law. Locations Zurich, Switzerland; BEL – Lessines; CHE – Neuchâtel; Hikari, Japan; IRL – Bray – Production; IRL – Dublin – Baggot Street; IRL – Grange Castle – Production; Lexington, MA; Oranienburg, Germany; SGP – Singapore – Woodlands; USA – CA – Thousand Oaks - Rancho Conejo; USA – MA – Cambridge; USA – MN – Brooklyn Park #J-18808-Ljbffr
Job Description Are you looking for a patient‑oriented, innovation‑driven company that inspires you and promotes your career? Then take your future in your hands and become part of Takeda as a Quality Compliance Lead - External Biologics. Based at Takeda’s Baggot Street site, you will spearhead inspection readiness and compliance across CMOs and CTLs. Acting as the vital link between Global Quality Compliance and External Biologics, you will play a key role in safeguarding product quality and ensuring patient safety—making a real impact across Takeda’s External Biologics supply. How You Will Contribute Lead External Biologics Regulatory Inspections at Takeda Ireland (HPRA & Russian MIT) and manage inspection readiness, support, and remediation across CMOs and CTLs. Lead and maintain the Takeda Baggot Street Site Master File (SMF) and Product Quality Review process for External Biologic Products. Lead the External Biologics Internal Audits, Self‑Inspection program, and Compliance Risk Assessments. Maintain knowledge of current applicable global regulatory requirements and apply cGMPs daily to ensure operational compliance. Manage day‑to‑day operations independently, providing strategic oversight, problem resolution, and risk mitigation. Routinely partner with senior management on critical compliance issues. Participate in and lead Continuous Improvement projects to enhance compliance and quality systems, supporting MAH activities for Takeda Pharmaceutical International – Ireland Branch. In this position you will report to the Head of Quality Systems and Compliance Biologics OpU Quality - External Manufacturing. What You Bring to Takeda Bachelor’s or advanced degree in a relevant scientific or technical discipline with minimum 8 years’ experience in Quality Systems and Compliance in biologics or sterile manufacturing. Proven leadership experience managing quality or technical teams in a global biopharmaceutical setting. Strong understanding of cGMP/GLP regulations, ICH guidelines, FDA CMC expectations, and related international standards. Demonstrated knowledge of biologics and aseptic manufacturing processes, systems, and technologies. Experience interacting with regulatory agencies and leading site or external partner inspections. Ability to influence, collaborate, and communicate effectively across internal and external stakeholders with strong analytical, risk assessment, and decision‑making skills. Commitment to Takeda’s values—Patient, Trust, Reputation, and Business—driving quality excellence across all activities. What we can offer you Employer funded private medical insurance with dependants’ cover Competitive salary and performance‑based bonus Employer retirement plan contributions Flexible working arrangements 26 vacation days plus additional days for service milestones Family friendly policies Employee Assistance Program Wellbeing and engagement teams Employer life insurance contributions Development opportunities Educational programs and formal training Coaching and mentoring Employee Stock Purchase Plan Revenue approved profit share scheme Humanitarian volunteering leave options Employer funded income protection On‑Site Gym Flexible employee funded options like Dental Insurance, Partner Life Insurance, Serious Illness Protection, Fuel Card, Bike to Work, Commuter Ticket, and Insurance Deals Electric charging points available at parking locations Takeda Resource Groups About Us Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life‑transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma‑derived therapies, oncology, neuroscience, and vaccines. Takeda Ireland was established in 1997. Our story in Ireland is one of substantial growth, rapid change, and innovation. Over the past years, Takeda Ireland has invested over €55 million in Ireland to develop our manufacturing sites. Solidifying our commitment in our people and contributing to the local economy. Takeda in Ireland has commercial operations, corporate services, and manufacturing facilities across four locations: Baggot St, Bray, Citywest, and Grange Castle. We have been certified as Top Employer for several consecutive years. How we will support you Takeda is proud of its commitment to create a diverse workforce and to provide equal employment opportunities to all employees and applicants for employment without regard to ethnicity, colour, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status or any other characteristic protected by law. If you are living with disabilities, chronic illness, or neurodiversity, please feel free to let us know so that we can provide you with appropriate support during the application process. Locations IRL - Dublin - Baggot Street Worker Type Employee Worker Sub‑Type Regular Time Type Full time #J-18808-Ljbffr
A global biopharmaceutical company in Dublin seeks a Quality Compliance Lead - External Biologics to spearhead regulatory inspections and maintain compliance across its biologics product lines. The successful candidate will have a relevant degree, over 8 years of experience, and proven leadership in quality systems. This role offers competitive salary, benefits including medical insurance, retirement contributions, and flexible working arrangements, as well as opportunities for professional development. #J-18808-Ljbffr
A leading pharmaceutical firm in Dublin is seeking an Environmental, Health & Safety Specialist to assist in implementing ISO 14001 and ISO 45001 Management Systems. The ideal candidate will have 3-5 years of experience in a similar role and a degree in Environmental Science or a related field. Responsibilities include providing technical support for compliance systems and delivering EHS training. The position offers a competitive salary and benefits including retirement plan contributions and comprehensive insurance coverage. #J-18808-Ljbffr
Environmental, Health & Safety Specialist Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda Ireland’s Grange Castle campus is expanding with the recent announcement of a new extension to our new cell therapy manufacturing facility. Two new temporary contract positions have been created within the site EHS team with a primary focus on strengthening our EHS management programmes and providing additional EHS support to meet site expansion. Job Purpose Assist & drive the implementation of ISO 14001 & ISO 45001 Management Systems on site. Implement standardised and comprehensive EHS programmes across the site that meet best practice and compliance obligations. Provide technical support and drive the implementation of new processes & compliance systems related to all aspects of environmental management programmes across site and in accordance with the Industrial Emissions Licence. Candidates should have at a minimum at least 3-5 years experience in a similar role. How You Will Contribute Implement ISO 14001 & 45001 Management Standards. Implement & update existing programmes to align with new Corporate EHS Standards. Ensures that site operations are carried out at all times in compliance with the sites EPA Industrial Emissions Licence. Support EHS CAPA development and closure. Develops and delivers EHS training to the site. Provides technical EHS support & expertise to all Departments and personnel on site. Deputises for other members of the EHS team as required. Participates in the site Emergency Response programme and supports continuous improvement activities. Other duties as required by the EHS Manager. What You Bring to Takeda Holds a degree in Environmental Science or Health & Safety or Chemical Engineering and has/is working as an EHS Specialist/SME within a Pharmaceutical /Chemical manufacturing facility. Has relevant experience of working towards ISO 14001/45001 certification. Is passionate about EHS and achieving excellence and has demonstrated this in previous projects and employment. Is strong technically and has a “hands on” approach to EHS and demonstrated problem solving skills. Has an entrepreneurial approach and is comfortable working in teams or on their own initiative to deliver rapid results & improvement. Has a positive collaborative working style. Has excellent written & verbal communication skills. Is flexible and willing to take on other tasks and duties as required by the demands of the business. Is results driven and has the ability to handle complexity and multiple priorities. Experienced in the implementation and execution of successful EHS programmes that drive continuous improvement within manufacturing operations and align with current & future EPA & HSA compliance requirements. Ideally is an SME in a particular area such as Environmental Management, Process Safety, High Risk Work, Ergonomics or otherwise. What you can look forward to with us Competitive Salary Including performance-based bonuses. Retirement Plan Employer contributions to your retirement plan. Comprehensive Insurance Employer-funded private medical insurance with dependants’ cover, life insurance, and flexible options like dental insurance, partner life insurance, and serious illness protection. Electric Charging Points Available at parking locations. Employee Assistance Program Support for personal and professional challenges. Wellbeing and Engagement Dedicated teams to support your wellbeing. Family-Friendly Policies Supportive policies for a balanced work-life. Generous Vacation 26 vacation days plus additional days for service milestones and humanitarian volunteering leave. Development Opportunities Coaching, mentoring, educational programs, and formal training. Subsidized Canteen Enjoy meals at a reduced cost. Flexible Benefits Options like fuel card, bike to work, commuter ticket, and insurance deals. More about us At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Equal Employment Opportunity Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law. Location Grange Castle, Ireland Employee Details Worker Type: Employee Worker Sub-Type: Regular Time Type: Full time Seniority Level Mid-Senior level Employment Type Full-time Job Function Management and Manufacturing Industries Pharmaceutical Manufacturing #J-18808-Ljbffr
A global pharmaceutical company is seeking an EHS Specialist to implement ISO 14001 and ISO 45001 Management Systems at their site in Dublin. The ideal candidate will have a degree in Environmental Science or similar and at least 3-5 years of relevant experience in EHS roles within pharmaceutical or chemical manufacturing. Responsibilities include managing EHS standards, providing technical support, and conducting training. This is a full-time position with a comprehensive benefits package included. #J-18808-Ljbffr
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda Ireland’s Grange Castle campus is expanding with the recent announcement of a new extension to our new cell therapy manufacturing facility. Two new temporary contract positions have been created within the site EHS team with a primary focus on strengthening our EHS management programmes and providing additional EHS support to meet site expansion. Job Purpose: The primary purpose of these positions is to: Assist & drive the implementation of ISO 14001 & ISO 45001 Management Systems on site. Implement standardised and comprehensive EHS programmes across the site that meet best practice and compliance obligations. Provide technical support and drive the implementation of new processes & compliance systems related to all aspects of environmental management programmes across site and in accordance with the Industrial Emissions Licence. Candidates should have at a minimum at least 3-5 years experience in a similar role. How You Will Contribute: Implement ISO 14001& 45001 Management Standards. Implement & update existing programmes to align with new Corporate EHS Standards. Ensures that site operations are carried out at all times in compliance with the sites EPA Industrial Emissions Licence. Support EHS CAPA development and closure. Develops and delivers EHS training to the site. Provides technical EHS support & expertise to all Departments and personnel on site. Deputises for other members of the EHS team as required. Participates in the site Emergency Response programme and supports continuous improvement activities. Other duties as required by the EHS Manager. What You Bring to Takeda: Holds a degree in Environmental Science or Health & Safety or Chemical Engineering and has/is working as an EHS Specialist/SME within a Pharmaceutical /Chemical manufacturing facility. Has relevant experience of working towards ISO 14001/45001 certification Is passionate about EHS and achieving excellence and has demonstrated this in previous projects and employment. Is strong technically and has a “hands on” approach to EHS and demonstrated problem solving skills. Has an entrepreneurial approach and is comfortable working in teams or on their own initiative to deliver rapid results & improvement. Has a positive collaborative working style Has excellent written & verbal communication skills. Is flexible and willing to take on other tasks and duties as required by the demands of the business. Is results driven and has the ability to handle complexity and multiple priorities. Experienced in the implementation and execution of successful EHS programmes that drive continuous improvement within manufacturing operations and align with current & future EPA & HSA compliance requirements. Ideally is an SME in a particular area such as Environmental Management, Process Safety, High Risk Work, Ergonomics or otherwise. What you can look forward to with us: Competitive Salary: Including performance-based bonuses. Retirement Plan: Employer contributions to your retirement plan. Comprehensive Insurance: Employer-funded private medical insurance with dependants’ cover, life insurance, and flexible options like dental insurance, partner life insurance, and serious illness protection. Electric Charging Points: Available at parking locations. Employee Assistance Program: Support for personal and professional challenges. Wellbeing and Engagement: Dedicated teams to support your wellbeing. Family-Friendly Policies: Supportive policies for a balanced work-life. Generous Vacation: 26 vacation days plus additional days for service milestones and humanitarian volunteering leave. Development Opportunities: Coaching, mentoring, educational programs, and formal training. Subsidized Canteen: Enjoy meals at a reduced cost. Flexible Benefits: Options like fuel card, bike to work, commuter ticket, and insurance deals. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Empowering our people to shine: Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law. If you are interested in this opportunity, we look forward to receiving your application via our online tool! Locations Grange Castle, Ireland Worker Type Employee Worker Sub-Type Regular Time Type Full time #J-18808-Ljbffr
Associate Director, API Process Engineering Join to apply for the Associate Director, API Process Engineering role at Takeda . Job Description: As Associate Director, API Process Engineering, you will be Takeda’s global expert for small‑molecule API manufacturing processes across batch and continuous platforms. You will apply chemical engineering and process chemistry fundamentals to design, scale, and control API processes from clinical development through commercial supply. Through the integration of mechanistic modelling, process simulation, and rigorous data analysis you will deepen process understanding, strengthen control strategies and support regulatory submissions for global markets. You will become the central hub for API process knowledge, driving best practices and continuous improvement across Takeda’s manufacturing network and external CMOs. How you will contribute: Lead the Small Molecules API Manufacturing Sciences activities within Global Process Science, serving as expert for small‑molecule API processes and technologies. Provide process engineering support for batch and continuous API platforms from clinical through commercial stages, integrating process chemistry and engineering perspectives. Apply mechanistic modelling, process simulation, and quantitative analysis to enhance process understanding and enable robust process control. Lead API manufacturing process characterization, including risk assessments and definition of critical process parameters and controls. Lead technology transfer of API processes between internal sites and external CMOs, ensuring robust, reproducible, and compliant implementation. Lead API process validation activities, including strategy, protocol design, execution support, and data evaluation. Develop and implement strategies for continuous improvement of marketed API processes, including yield optimization, robustness improvements, cost of goods (COGs) reduction, and capacity expansion. Establish and maintain systems and procedures for best practice in commercial technology transfer and process validation. Build and oversee a central knowledge base of API process and product understanding, ensuring lessons learned are shared across products, sites, and functions. Collaborate closely with GMS functions (e.g., Small Molecules Operations Units, network strategy), site leadership, Technical Services, Pharmaceutical Sciences, Global Quality, and Regulatory CMC. Provide technical support to marketing applications for global markets and lead preparation of responses to regulatory questions from health authorities. Utilize structured root cause analysis techniques to investigate process and equipment issues and deliver robust, sustainable corrective and preventive actions. Provide subject matter expertise for due diligence in mergers and acquisitions and in‑licensing evaluations. What you bring to Takeda: At least a Master’s degree in an area related to Chemical Engineering, Process Engineering, or Pharmaceutical Engineering. At least 5 years of experience in a cGMP manufacturing environment and at least 5 years of pharmaceutical industry experience in small‑molecule APIs (these may overlap). Strong foundation in organic/pharmaceutical chemistry and chemical engineering, with applied experience in API manufacturing processes. In‑depth understanding of pharmaceutical manufacturing processes, ICH guidelines, and current global regulatory requirements relevant to API processes. Demonstrated experience in mechanistic modelling, process simulation, and data‑driven process optimization. Proven track record leading API process characterization, technology transfer, process validation, and lifecycle changes in a multi‑site or global context. Strong problem‑solving, project management, and stakeholder management skills, including the ability to resolve conflicts and drive clear decisions in cross‑functional teams. Excellent written and verbal communication skills, including experience preparing high‑quality technical reports and presenting project results to diverse audiences. Ability to work independently and proactively while collaborating effectively within multi‑disciplinary teams (Engineering, Manufacturing Operations, Manufacturing Sciences, CMC teams, and others). Commitment to sharing knowledge across functions and sites and to building sustainable technical capabilities in the organization. Intellectual curiosity about technology and new ways of working, coupled with a collaborative and open mindset. Willingness to travel to our international manufacturing sites and work side‑by‑side with site teams on highly complex issues. Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law. Locations Zurich, Switzerland; AUT - Wien - Industriestrasse 67; BEL - Lessines; CHE - Neuchatel; Hikari, Japan; IRL - Bray - Production; IRL - Dublin - Baggot Street; IRL - Grange Castle - Production; Lexington, MA; Linz, Austria; Oranienburg, Germany; SGP - Singapore - Woodlands; USA - CA - Thousand Oaks - Rancho Conejo; USA - MA - Cambridge; USA - MN - Brooklyn Park Worker Type: Employee Worker Sub-Type: Regular Time Type: Full time Seniority level: Mid‑Senior level Employment type: Full-time Job function: Engineering and Information Technology; Industries: Pharmaceutical Manufacturing #J-18808-Ljbffr
A pharmaceutical company is seeking a talented Associate Director in Dublin to lead API Process Engineering. The ideal candidate will leverage their expertise in small-molecule manufacturing processes and contribute to continuous improvement initiatives. Applicants should possess a Master’s degree along with substantial experience in the pharmaceutical industry. This role involves collaboration with global teams to drive best practices and regulatory compliance. #J-18808-Ljbffr
