R&D Manager We are delighted to partner with a world leading medical device development company to fill the key role of R&D Manager. Main responsibilities will include: Product Development: Coordinates and/or directs all aspects of product development activity related to a product line, including integration of RA, QA/QE, Operations, Clinical, Marketing, Sales and Packaging Engineering. Works with Operations and Supply Chain to deliver a new product to market in line with division and operational goals. Project Management: Creates and tracks project schedules, plans and budgets for the development of a new product (or line extension) and assesses department priorities. Makes assignments to direct reports to ensure projects and company priorities are met. Coordinates with cross functional peer and team members, internal and external suppliers and outside professionals to ensure department projects are developed to plan. Design to Manufacturing Transfer: Proposes and facilitates the selection of a new products manufacturing location. Oversees the transfer of new products to manufacturing locations. Design: Oversees the designs, development and implementation of new products and processes of a medical device. Oversee and contribute ideas and/or intellectual property submissions including but not limited to the development of new products and processes. Process Development: Oversees R&D project leaders, engineers and manufacturing teams in the development of developing new processes through the understanding key process inputs and outputs, including vendor selection and negotiation. Documentation: Review product development plans, design reviews, technical documents and reports. Review and approve verification and validation protocols and reports. Develops and implements department and division procedures/policy. Test Method Development: Oversee the development of clinically relevant test methods that adequately challenge new product design and processes. Testing: Oversee the planning and execution of qualification activities for new products and processes. Training: Train NPD teams, R&D technicians and engineers on new design and process development procedures as well as division procedures and policies. Supervisory/mentoring/coaching: Mentor/coach R&D teams through New Product Development activities. Typically supervises/manages R&D (project) teams, conducting performance reviews, recommending salaries and promotions, training, interviewing and hiring decisions, and disciplinary actions. Fiscal: Creates, controls, manages a department budget (expense and capital expenditure). Critique engineering cost analysis. Reviews and analyses costs to identify and implement cost improvements. Other Responsibilities may include, however are not limited to: Support Manufacturing, Quality, Regulatory and R&D to ensure systems are compliant with all internal and external guidelines. Support design and process root cause analysis and support non-conforming product and complaint investigations. About you: B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline with Biomedical Engineering or Bioengineering degree preferred. 8+ years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment. Demonstrated knowledge of development, manufacturing and quality system requirements for medical devices or comparably regulated environment is required. Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialisation; ability to execute validation. Ability to create and deliver project plans and lead multifunctional teams. Excellent oral and written communication skills, with strong, demonstrated skills in communicating with all levels of technical and operating management. Strong ability to analyse and use technical data and resources. Proficient in statistic software. Trained in Six Sigma or Design for Six Sigma. #J-18808-Ljbffr
Our client, a Biotech company, now seek a Clinical Pharmacologist with a strong quantitative background to support clinical development through clinical pharmacology, modelling & simulation, and pharmacokinetic analysis. The role is primarily technical and execution‑focused, with responsibility for study‑level delivery across all phases including PK analysis, PBPK and population PK/PD modelling, for the interpretation of clinical and nonclinical data, preparation of clinical pharmacology deliverables, and presentation of results in cross‑functional settings. The role requires close collaboration with Clinical Operations, Biostatistics, Regulatory, CMC, Toxicology, and Non‑clinical, and the ability to translate quantitative analyses into clear, development‑relevant conclusions. This position requires scientific leadership, independence, and accountability for high‑quality outputs, while working in a fast‑paced environment. Responsibilities Provide hands‑on PK analysis and modelling support for clinical studies (Phase 1–3), including noncompartmental analysis, population PK/PD modelling, and PBPK modelling, as appropriate. Develop, implement, maintain, and interpret PBPK and population PK/PD models to support dose selection, study design, device/formulation bridging, special populations, and regulatory questions. Contribute to the design, analysis, interpretation, and reporting of clinical pharmacology components of clinical studies, under the direction of the Head of Clinical Pharmacology. Author and/or contribute to high‑quality clinical pharmacology deliverables, including study reports or sections thereof, protocols, investigator brochures, modelling reports, and responses to regulatory questions. Integrate clinical pharmacology and pharmacometrics insights with nonclinical PK/ADME, clinical safety, and efficacy data to support development decisions. Support cross‑functional teams by presenting analyses and modelling results at study team meetings, internal governance forums, and selected external interactions. Collaborate effectively with Clinical Operations, Biostatistics, and external vendors/CROs to ensure appropriate data flow, analysis standards, and timelines. Critically evaluate data quality, assumptions and limitations in PK and modelling analyses, and clearly communicate uncertainty and impact on development decisions. Requirements BSc in Life Science, plus Post‑graduate qualification (i.e. PhD or MSc) in a relevant life sciences or quantitative discipline (e.g. clinical pharmacology, pharmacometrics, pharmaceutical sciences, biomedical, or similar). 5+ years of experience in pharmaceutical, biotechnology, and/or CRO environments, with hands‑on involvement in clinical development programs. Hands‑on PK analysis experience using Phoenix WinNonlin. Hands‑on PBPK modelling experience using tools such as Simulations Plus GastroPlus, SimCYP and/or PK‑Sim/MoBi, including model development, verification, and interpretation. Experience using R (RStudio) and/or Python for data handling, analysis, and visualization. Preference for population PK/PD modelling experience using Phoenix NLME, including model development and application. Demonstrated ability to analyse complex datasets, build and interpret models, and communicate results clearly and practically to multidisciplinary audiences. Willing to expand into adjacent areas (e.g. DMPK, TK, clinical trial operational support) as required by program needs. #J-18808-Ljbffr
Sourcing and Contracting, Associate Director Our client is a highly successful, and ambitious global biopharmaceutical company with a strong commercial portfolio and drug pipeline. With a passion for best practice in every aspect of its business, this well-managed, high performing company has a motivated workforce who are passionate about operational excellence. Job Spec We are seeking a strategic sourcing leader (MUST HAVE 5 years progressive experience in pharma, with API, DS, DP experience desirable) to join the Supply Chain team as Associate Director of Sourcing & Contracting. This role is central to developing and executing sourcing strategies for direct materials in the Drug Substance, Drug Product or Packaging categories. The successful candidate will develop category strategies and lead cross-functional sourcing projects align market intelligence with business needs and drive supplier selection lead contract negotiations to optimize overall value, service levels and risk mitigation The role requires strong collaboration across functions such as Procurement, Supply Chain, Legal, Finance, Quality, Technical Operations, and EHSS to deliver value-driven outcomes and ensure a resilient, sustainable, compliant, and competitive sourcing & contracting framework. Lead sourcing activities with cross-functional teams in developing and executing sourcing projects Define, build and plan alignment on category strategies for Active Pharmaceutical Ingredients (API), Drug Product or Packaging Work with Supply Chain leadership in the establishment, communication, and implementation of business goals and objectives Partner with Supply Chain, R&D, Procurement, Legal, Finance, Quality, Technical Operations, EHSS, and other functions as required across the internal network, to deliver value-driven sourcing outcomes aligned with business goals. Develop and implement sourcing strategies in key sourcing categories that results in a sustainable competitive advantage. Gather Market Intelligence and trends from third party contract manufacturers. Build alignment between business needs and market dynamics. Implement the strategic direction for Supply Chain Sourcing efforts and execute tactical and strategic sourcing processes. Achieve optimal balance between collaborative engagement with suppliers and competitive pressure, to ensure maximum value is realised. Guide internal stakeholders through a data-driven supplier selection process. Manage the contracting process for commercial contracting activities associated with company proprietary commercial and pipeline products. Support contract negotiations to optimize overall value including financial outcomes, service levels and risk mitigation. Monitor contracts and pro-actively manage contracting activities with close-out, extension, or renewal according to what’s best for the company. Prepare and draft contracts in collaboration with the contract business owners and legal teams. Develop and implement a standard sourcing process appropriate for sourcing of direct goods and services need and aligned with Global strategic sourcing policy. Establish and support a work environment of continuous improvement that supports the company Policies and systems, and appropriate regulations in Pharma. Assist with the preparation and management of departmental budgets. Builds strategic and trusting relationships through demonstrated technical capability, critical thinking, and collaborative behaviours. Person Spec Established business qualification with related experience. Masters in a Supply Chain or Business-related field preferred. MUST HAVE 5 years progressive experience in pharma, with API, DS, DP experience desirable. Strong experience in conducting sourcing projects from inception to execution. Experience in contract development & negotiation with demonstrated delivered value. Experience working in a regulated industry with quality management system is desirable, including general knowledge of GMP and CFR’s. Proven leadership skills – ability to influence and motivate others to quickly achieve results. High energy and passion for excellence. Self-confident with an ability to accept and respond to challenges in a positive manner. Ability to effectively present complex topics in a concise manner. Positive attitude, strong collaboration and interpersonal skills required to effectively address problems and interface with other functional areas while working in a global environment. Position based in Ireland. Travel domestic and international – up to 20%. COMPETENCIES Business Acumen Influences short and long-term departmental direction. Supports others in understanding how site goals contribute to the company’s objectives. Benchmarks externally and develops strategic vision at department level. Executes on the strategic plan. Teamwork/Leadership Acts as a role model/mentor, providing direction and feedback to others in a respectful manner. Builds cross-site teams that collaborate effectively and deliver milestones. Adapts a flexible, leadership approach appropriate to the situation, while motivating and inspiring others Communication Prepares and delivers clear and effective presentations for senior management across the company. Communicates effectively by tailoring messages appropriately for internal and external audiences Accountability May represent site on global projects. Ensures accountability for all project aspects from inception through successful delivery. Translates concepts into accountable action plans and drives implementation. #J-18808-Ljbffr
The RFT Group in Dublin is seeking an Associate Director for Sourcing and Contracting. This strategic role demands a leader with at least 5 years in pharma, focusing on developing sourcing strategies for direct materials. Key responsibilities include leading sourcing projects, managing vendor relationships, and driving contract negotiations. The ideal candidate possesses strong experience in sourcing execution, negotiation, and collaboration across various functions. The position involves up to 20% travel and offers an opportunity to impact operational excellence. #J-18808-Ljbffr
Our client is a young exciting publicly listed clinical-stage company dedicated to transforming the lives of patients in its therapy areas. With its novel and proprietary drug products and current clinical development programs our client is aiming to provide improved treatments for patients with increased remission rates, faster onset of action, durable effects, and improved tolerability and convenience. This requires experience and a track record of successful development in complex and innovative areas, and excitement for creating something new and groundbreaking. Overall Purpose: Our client is looking for a Director of Regulatory Affairs CMC to work closely with the existing regulatory team, internal and external experts, and collaborate and contribute towards successful execution of their pivotal clinical program and commercialization. This requires practical experience and a proven track record in overseeing clinical regulatory activities in complex and innovative areas, preferably in CNS/psychiatry, including Sponsor oversight of CTAs and managing in-house clinical trial preparations, and a passion for creating something new and groundbreaking. Job Spec: Lead the development and execution of the global CMC regulatory strategy across all pipeline programmes, from Phase 1 through to marketing authorisation, ensuring alignment with overall development strategy and company timelines. Author, review, and take overall accountability for high-quality CMC sections of regulatory submissions, including Module 3 (CTD), IMPDs, INDs, and responses to agency questions, ensuring compliance with eCTD requirements and international guidelines. Lead CMC interactions with regulatory agencies, including the FDA and EMA, taking primary responsibility for the preparation and execution of formal meetings (Type B/C meetings, scientific advice, EOP2) and ensuring robust follow-through on agency commitments and feedback. Provide CMC regulatory leadership for combination product development programmes, working closely with technical development and device teams to ensure compliance with applicable regulatory frameworks (e.g., 21 CFR Parts 3 and 4) across US, EU, and UK markets. Act as the CMC regulatory representative on cross-functional product development teams, providing strategic guidance on manufacturing, analytical, and quality matters and ensuring CMC regulatory considerations are integrated into programme planning from the outset. Support the establishment and ongoing development of the Quality Management System (QMS), including contributing to the authoring and review of CMC-relevant SOPs, quality agreements, and regulatory procedures in a growing GMP environment. Oversee the management and maintenance of CMC regulatory submissions and correspondence using regulatory document management systems, ensuring version control, audit-readiness, and compliance with document retention policies. Proactively monitor and interpret changes in the global CMC regulatory landscape (ICH guidelines, FDA/EMA guidance updates, manufacturing and quality standards), communicate impacts to internal stakeholders, and adapt regulatory strategies accordingly. Champion the adoption of emerging technologies, including AI-driven tools within regulatory affairs and CMC operations, identifying opportunities to enhance efficiency, submission quality, and regulatory intelligence. Maintain and develop external regulatory networks and CMC expertise, proactively identifying training and development opportunities and keeping the organisation at the forefront of evolving CMC regulatory science and best practice. Maintain a professional and credible image with regulatory agencies, CMC consultants, CDMOs, vendors, and internal colleagues, acting as an ambassador for the highest standards of CMC regulatory practice. Provide regulatory oversight of CMC activities conducted by external partners including CDMOs and regulatory vendors, ensuring deliverables meet quality standards and are aligned with submission timelines and agency expectations. Person Spec: Bachelor's degree or advanced degree (MS, PhD, or MD) in Life Sciences or a Health-Related discipline. Demonstrated experience authoring Module 3 (CTD) submissions and Investigational Medicinal Product Dossiers (IMPDs), with a strong command of CMC documentation standards across global regulatory frameworks. Proven track record supporting CMC regulatory strategy from Phase 1 through late-stage development, with experience navigating the evolving requirements at key development milestones. Experience leading CMC interactions with the FDA including the preparation, coordination, and execution of formal regulatory meetings. Direct experience with End-of-Phase 2 (EOP2) meetings, including strategic preparation and managing agency feedback on CMC programmes. Experience supporting the development and regulatory strategy for combination products, with an understanding of the applicable regulatory frameworks (e.g., 21 CFR Parts 3, 4). Experience contributing to the establishment and implementation of Quality Management Systems (QMS) in a regulated environment. Proficiency with regulatory document management systems and electronic submission platforms. Knowledge of global regulatory guidelines, GxPs, local regulations and industry best practices. Experience of technical/regulatory writing (e.g. briefing books, responses to questions, applications for early access schemes, paediatric plans etc). Experience of working with multi-located cross-functional teams including in an outsourcing model using regulatory vendors. Proficient in pertinent software such as Microsoft Office Suite and Adobe Acrobat. Experience across a range of therapeutic areas; experience in psychiatry and/or neurology is a benefit. A genuine interest in the application of artificial intelligence and emerging technologies within regulatory affairs, and an enthusiasm for how these tools can enhance regulatory strategy and operations. Comfort operating within a small biotech environment, with the ability to work with agility, take ownership across multiple workstreams, and contribute beyond a narrowly defined role Knowledge and Abilities: Strong attention to detail with exceptionally high standards for document and submission quality. Excellent written/oral communication skills. Team oriented and flexible Able to manage conflicting priorities. The attitude and ability to be effective in a lean, small company environment in early-stage research biotech business in pre-revenue/profits phase. Ability to embrace and drive change across functions. Energetic and enthusiastic. An entrepreneurial, business-oriented mindset and a strong fit with the company team; willing to "roll their sleeves up". #J-18808-Ljbffr
Associate Director, External Manufacturing API Our client, an ambitious global biopharmaceutical based in Dublin, with a strong drug development pipeline and commercial portfolio, now have a permanent role for an Associate Director of API for External Manufacturing within theirvirtual organisation . This role is based in Ireland, hence this hire will reside in Ireland and hybrid office presence 1 day per week, or every second week plus travel internationally. The API process expert will be responsible as the technical lead representative supporting API manufacturing at Contract Manufacturing Organizations’ (CMO’s) and subsequent processing of API’s in Drug Product (DP) processes across OSD and injectables. This hire will support new product introductions, technology transfers, continually monitor and improve API operations conducted at CMO’s for this Biopharma company. Responsibilities Review and maintain company practices & systems in managing contract manufacturers to ensure compliance with cGMP, and other regulatory requirements.. Deep understanding of chemical processes from both scientific and engineering perspective demonstrating expertise in how API processes are developed and controlled to maximize yield and minimize impurities. Perform trending on CMO API processes and identify opportunities for CI providing technical leadership to implement such improvements to deliver on safety, efficiency and/or compliance. Oversee activities related to API production across the commercial supply network including routine production and associated monitoring/control plans as well as investigations, change controls and CAPA’s ensuring processes are robust, efficient and in control. Understand and identify key chemical and physical attributes of API material as it pertains to downstream processing in the drug product process. For new processes ensure that the process is well defined with appropriate identification of CQAs and CPP’s with appropriate measurement of both. In conjunction with Commercial Supply Chain oversee network optimization to include vendor selection and technology transfers/validations as required. Maintain the process control strategy documentation through the commercial part of the lifecycle of the API. Provide technical input into the commercial master batch records. Provide input into the Specification and Commercial Purchasing Specification. Provide technical input into Process FMEA and Change Risk assessments. Provide technical review of regulatory filings supporting CMC aspects of regulatory dossiers, providing input and guidance around the manufacturing control strategy prior to filing and process validation. Support validation planning and execution of APIs as needed as part of cross functional teams involving Supply Chain, Quality and Validation. Work closely with the Process Development providing that link between Development and Commercial manufacturing throughout the product lifecycle. Provide commercial technical requirements for all molecules transitioning from Development to Commercial. Required to provide input and guidance to the manufacturing decision making processes prior to filing and validation. Support company CMOs in regulatory and external auditor inspections and respond to observations as needed. Support the Operations leadership with the project management and implementation of key technical projects which are identified as part of the company’s objectives in both CMOs and company facilities. Manage, coach and develop direct reports ensuring that they deliver and reach their potential. Partnership Establish and maintain strong working relationships to build partnerships based on trust with CMOs. Develop recommendations for strategic/business decisions. Provide management with accurate and timely information necessary to make strategic, investment and operating decisions. Preparation of CMO competency assessment to ensure robust decision-making processes when it comes to vendor selection and vendor optimization discussions with senior management. Facilitate the transfer of new products and development projects to site’s through the development of effective business cases and management support. Preparation of credible and reliable business plans, budgets, and forecasts. Foster and promote internal collaboration. Ensure support and integration of Technical Operations with relevant functions to achieve customer service objectives. Requirements Bachelor’s degree in relevant technical/engineering/scientific discipline, preferably multi-disciplinary with a strong technical/scientific (Chemistry / Chemical Engineering) orientation. 8-12 years’ experience in high volume/manufacturing/relevant environment likely to include: Pharmaceutical with a minimum of 2 years at senior level. Established track record with evidence of excellent project management, problem solving, collaborative, leadership and communication skills. Process safety in API environment. Strong understanding and experience of technical/scientific challenges in production processes across both API and Drug Product (DP) processes with proven track record demonstrating issue resolution. Circa 20% of domestic / international travel associated with this role. For further details please contact Larry on +353 (0)1-2302400 / larry@rftgroup.ie The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie #J-18808-Ljbffr
A global biopharmaceutical company in Dublin seeks an Associate Director for External Manufacturing in API. This role focuses on overseeing API production, ensuring regulatory compliance, and liaising with contract manufacturing organizations. The ideal candidate will have a technical background, extensive experience in manufacturing, and strong leadership skills. Hybrid work is available, with some international travel required. A Bachelor's degree in a relevant field is necessary for consideration. #J-18808-Ljbffr
Overview Senior Regulatory Medical Writer, Biotech. Our client is a Biotech company with a strong pipeline and wishes to hire an experienced Regulatory Medical Writer (Senior to Principal level) within their Clinical Development team, working closely with functional teams e.g. Clinical Operations, Regulatory Affairs, Medical Affairs, Commercial, etc. The successful candidate will author, review and manage clinical documents, e.g., clinical study protocols and amendments, investigator brochures, clinical study reports and clinical summaries, and regulatory development documents for FDA, EMA, MHRA, etc. This hire will be based in either Ireland or the UK, with flexibility to work remotely from their own home office, with occasional travel to their office. The ideal candidate will be an experienced Medical / Regulatory Writer of clinical documents in clinical research, and writing clinical components in regulatory filings (NDA, BLA, MAA) within Pharma / Biotech environment. Responsibilities Liaise with medical/clinical experts, statisticians, investigators, and other relevant stakeholders during document development. Update clinical and non-clinical regulatory documents throughout their lifecycle. Support applications to authorities and draft briefing packages. Oversee publications of key guidelines within relevant diseases and support internal training. Draft literature reviews, abstracts, posters, slide decks, working from various data sources including clinical study reports, protocols, etc. Coordinate trial team participation in the preparation of such documents, including facilitating meetings, developing and managing timelines, document review, and decisions. Support development of communication material and ensure company messaging is conveyed in a consistent scientific manner across documents. Generate templates and ensure alignment across documents. Support the development of communication material. Qualification and experience requirements BSc in Life Sciences. Advanced qualifications preferred e.g. PhD and Post Doctorate work. 5+ years Pharma / Biotech industry experience, 2 years of which in Regulatory Medical Writer role or similar. In-depth knowledge writing or editing clinical trial documents, e.g., Protocols, IBs, CSRs and clinical summaries to ICH GCP and regulatory requirements. Experience in preparation of clinical components in regulatory filings (NDA, BLA, MAA) is preferred. Strong analytical skills including good understanding of common statistical methods used in clinical trials and interpretation of their results. High quality standards and is committed to meet deadlines. Excellent written and oral communication skills within medical/science area. Solid ability to perform background literature research. Excellent English (written and spoken). Excellent attention to detail. For further details, please contact Larry on +353 1 – 2302400 / larry@rftgroup.ie The RFT Group , BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie Follow us on Twitter, Facebook and LinkedIn #J-18808-Ljbffr
A pharmaceutical manufacturing company in Ireland is seeking an AutoCAD Technician & Engineering Drawings Coordinator for a hybrid role. The position involves managing and updating technical drawings and ensuring compliance with regulatory standards. Applicants should have strong AutoCAD skills and familiarity with tools like Revit and Navisworks. Good collaboration and communication skills are essential for success in this contractor role expected to last approximately 9 months. #J-18808-Ljbffr
AutoCAD Technician & Engineering Drawings Coordinator Our client, a pharmaceutical manufacturing company, now seeks an AutoCAD Technician & Engineering Drawings Coordinator for potentially 9 months to streamline and up‑grade the plant drawings. This will be a contractor role. An element of work will include physically walking down systems with technicians onsite (estimate a few days per month on site), so this is a hybrid role with a lot of remote working if preferred. Responsibilities Contribute to and coordinate all “Master” Drawings and all site drawing requirements. These drawings include P&IDs, Architectural Drawings, HVAC Schematics, Electrical Schematics, General arrangement drawings and Construction Details. Contribute to and update drawing register to keep track of all drawings and revisions to drawings. Updating and maintaining drawing management directory and archive to house all soft copies (.dwg and .pdf files) of drawings Help develop SOP for management of all “Master” drawings and distribution of these drawings. Applied edits/revisions to existing drawings using AutoCAD based on redlined copies of master drawings. Maintaining detailed 2D and 3D technical drawings for multidisciplinary projects. Review and coordinate engineering documentation, ensuring compliance with internal and regulatory standards. Requirements Fully proficient, skilled and experienced in using AutoCAD is required. Experience with Revit, Navisworks and GDMS (global drawing management system), ensuring compliance with quality standards, regulatory requirements, and project specifications is desirable. Experience in updating and managing CAD drawings and BIM models for pharmaceutical facilities and industrial projects is preferred. Maintain organized records of technical drawings and revisions, ensuring proper documentation control. Understanding and competence of pharma regulations and compliance e.g., FDA, cGMP, etc. is preferred. Required Soft skills / attributes include: Good collaboration skills, focused on customer service and facilitation. Effective communication and presentation skills. Strong ability to build working relationships in a professional environment. For further details please phone Larry on +353 1-2302400 / larry@rftgroup.ie #J-18808-Ljbffr
