Scientist, Pharmaceutical MS&T Drug Product

Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb IrelandBristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units.Ireland is home to External manufacturing’s global headquarters, the business unit responsible for the management of manufacturing contract operations (CMO’s) and ensuring reliable supply of product to patients across the Bristol Myers Squibb global network.This includes management of, and working in conjunction with, third party contract manufacturers and internal manufacturing sites. In Ireland, External Manufacturing has two sites; Global Headquarters based in Dublin 15 and a distribution centre in Shannon, Co Clare.The RoleProvide technical support and leadership to the External Manufacturing Organisation and Contract Manufacturing Organisations (CMOs).Ensure the transfer of robust manufacturing processes, including packaging and artworkEnsure robust process performance during commercial manufacture by use of continuous process verification and OPEXResponsibilitiesProvision of ongoing technical support and oversight for a portfolio of Active Pharmaceutical Ingredients (APIs), Intermediates and Starting Materials and/or Drug Products, Packaging and artwork, ensuring compliance and security of supply - metrics review, investigation close-out, change control review, annual reviews and continuous improvementDriving process capability analysis to assess process robustness. Identifying and executing process robustness improvement projects, where requiredSupporting CMO/vendor selection – preparation of technical information packages, participation in due diligence and site assessments, technical evaluation of requests for information (RFIs) and requests for proposal (RFPs)Managing technology transfers as requiredTechnical oversight and direction for process validation, as requiredProviding technical guidance in the understanding of root causes and corrective and preventive action (CAPA) identification for out of trend or out of specification results or deviations for API / intermediate / starting material manufacturing and/or DP, Packaging and Artwork processesDriving the use of strategies, resources and processes (OPEX, etc.) to improve processing efficiency and to ensure optimised technical support for manufacturing/packaging/artwork, technical transfer and scale-up of processesProvide support for change managementSupport all regulatory activities associated with changes to assigned products and new productsSupport operational management of CMO as per Supplier Relationship Management governance structureRepresent Manufacturing Science and Technology on project teams and works closely with Quality Assurance (QA), Global Procurement, Supply Chain, Supply Relationship Manager (SRM), Product Development (PD) and project team members in developing strategies and problem-solving efforts.Product robustness (where required) - technical lead for creation of process robustness monitoring plan, process control strategy, and provision of technical oversight of CMO sites to ensure continuous process monitoring for all products in scope.Where required develop programme of experimental work to support investigations and work with PD, CMOs and external resources as appropriate to implement the programme of work.cGMP Responsibilities/Critical Tasks Documentation (Transfer documentation, Appraisals, technical memos and reports, Regulatory filing, etc.)Deviation investigationsTechnical support for Change Control systemTraining Gap Analysis and PlanningManage Finance Work with assigned CMOs to identify and agree potential process optimisationsReduce costs associated with existing processesParticipate and lead on teams for cost reduction projectsQualifications, Knowledge and Skills Required:The role holder will have expert knowledge in one or more of the following areas:API process scale-up, technology transfer and manufacturing support (change control, investigations, process optimisation)Drug Product - Oral Solid Dosage, Semi-solids, Liquids, Sterile/Aseptic products manufacturingPackaging, artwork and/or device manufacturingThe role holder will have an understanding of engineering, analytical and regulatory (current Good Manufacturing Practices (cGMP), filing, Environmental Health and Safety (EHS)) aspects of API and/or drug product (DP) manufacture and/or Packaging.Demonstrated project management and technical leadership capability.Demonstrated capability in the use of standard tools for root cause analysis. Ability to close-out investigations and issues at CMOs.Understanding of statistical process analysis and control methods. Ability to use statistical software to analyse process related data to determine process capability or for troubleshooting purposesProven experience of technology transfer processExcellent verbal, written communications and presentations skills, to include the ability to document complex study plans and scientific reports; notifications to line management regarding critical issues related to product manufacturing and process validation where appropriate.Strong communication and negotiation skills as well as the ability to translate technical issues into business impact and relevant solutions.Ability to work on own and as part of a team and to drive issues to resolutionFor API - A graduate or post-graduate level qualification in chemistry, chemical engineering or related field. Ideally a Ph.D. qualification in Chemistry, preferably synthetic organic chemistryA 3rd level degree in science or a related fieldA minimum of five (5) years relevant industrial experienceProven record in pharmaceutical technology - pharmaceutical process scale-up, technical transfer and manufacturing/packaging/artwork support/activitiesThe qualified candidate demonstrates characteristics of our BMS Values. Why you should applyYou will help patients in their fight against serious diseases You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees. You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym