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Job DescriptionCompany Profile:
Takeda's Singapore biologics manufacturing facility focuses on manufacturing potentially life-saving medicines for patients suffering from rare blood disorders such as Hemophilia A and B. As part of the company’s Biologics Operating Unit network, the site is Takeda’s only biologics drug substance manufacturing facility in Asia. The facility has two buildings, including manufacturing suites and laboratories, as well as Takeda’s first positive energy building certified by Singapore’s Building and Construction Authority’s Green Mark scheme in 2022.
Job Title: Process Sciences Engineer (Manufacturing Sciences)
Location: Woodlands, Singapore
About the role:
Support/lead troubleshooting of manufacturing operations (Upstream/ Downstream) process/product issuesTechnical subject matter expert (SME) for manufacturing operations to resolve process issues, perform root cause analysis and impact assessment for process investigationsSupport evaluation of technologies, plan and execute process improvementsSupport and execute global manufacturing science initiativesPlan, support and execute site manufacturing science activities such as continuous process verification (CPV) program, technology transfer of new products and process monitoring and trendingHow you will contribute:
Support Site Manufacturing (Upstream/Downstream) Activities Through:
Planning and executing activities required for process investigation such as performing process impact assessment, participating and performing root cause analysis. Work with cross functional teams for process issues investigationAnalyzing process trends, monitoring process performance as part of the CPV program. Escalate and perform investigation in event of any out of trend or process issuesLeading process investigations to identify root cause and implement action plans to correct or prevent re-occurrencePlanning and executing process improvements and robustness projectsLeading/supporting cycle development for process parameters where applicableDrafting process training slides and providing process training to cross functional teamsRaising change controls as change owners for process changesPerforming impact assessments for relevant change controlsProviding technical /process parameters for creation and revision of master batch records. Review master batch records.Lead/Support Technology Transfer for New Technologies/Product Introduction Through:
Leading/Supporting the evaluation of new manufacturing technologies and/or equipment for process improvement or process capabilities buildPlanning and executing technical transfer activities according to project timelines. Raise change controls where applicable to support the technical transferMonitoring process performance and trending through the site CPV program. Proactively investigate where required to ensure process robustness.Performing risk assessment, drafting required technical transfer and process control strategy documents and updating lifecycle documentsAuthoring study and process validation protocols and reports where neededOthers:
Support audits, regulatory submissions and responsesSupport and execute global manufacturing sciences initiatives according to project timelinesResponsibility to adhere to any applicable EHS requirements.Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.Any other duties as assigned by supervisor.What you bring to Takeda:
Education and Experience Requirements
Bachelor’s Degree in Biochemistry, Chemistry, Chemical Engineering, Biotechnology, Biochemical Engineering with minimum 3 - 4 years of relevant experience or Master’s Degree with 2 years of relevant work experience or a fresh PhD in the relevant technical area.Hands-on experience with cell culture/ upstream processes and/or downstream processes in a manufacturing or development environment.Has knowledge of cGMPsKey Skills and Competencies
Strong technical knowledge and proficiency in process understanding and application in biopharmaceutical processesStrong analytical skills including demonstration of systematic evaluation of potential issues, correlation or cause and effect relationships, root cause analysis methodologyGood communication skillsWillingness to learnTeam worker/ able to work in matrix environmentIndependent worker/ Self starterMore 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.
LocationsSGP - Singapore - WoodlandsWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time