Hiring company: Takeda
Primary Objectives of this Job
• Act as technical support for manufacturing operations to resolve process issues, perform root cause analysis and impact assessment for process investigations
• Support manufacturing operations (Upstream) by troubleshooting process/product issues
• Lead evaluation of new technologies, plan and execute process improvements
• Plan and execute global manufacturing sciences initiatives
• Lead, plan and execute site manufacturing sciences activities such as continuous process verification (CPV) program, technology transfer of new products and process monitoring and trending
Responsibilities
• Support site manufacturing (upstream) activities through
o Planning and executing activities required for process investigation such as performing process impact assessment, participating and performing root cause analysis. Facilitate stakeholder buy-in from cross functional teams for action plans.
o Analyzing process trends, monitoring process performance as part of the CPV program. Escalate and perform investigation in event of any out of trend or process issues
o Leading process investigations to identify root cause and implement action plans to correct or prevent re-occurrence
o Planning and executing process improvements and robustness projects
o Leading cycle development for process parameters where applicable
o Drafting process training slides and providing process training to cross functional teams
o Raising change controls as change owner for process changes
o Performing impact assessments for relevant change controls
o Providing 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
o Leading/Supporting the evaluation of new manufacturing technologies and/or equipment for process improvement or process capabilities build
o Planning and executing technical transfer activities according to project timelines. Raise change controls where applicable to support the technical transfer
o Monitoring process performance and trending through the site CPV program. Proactively investigate where required to ensure process robustness.
o Performing risk assessment, drafting required technical transfer and process control strategy documents and updating lifecycle documents
o Strategizing and authoring process validation protocols and reports where needed
o Authoring process related sections for regulatory submissions
• Mentor and train junior manufacturing sciences engineers
• Support audits, author regulatory submissions and responses
• Support and execute global manufacturing sciences initiatives according to project timelines
• Responsibility 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.
Education and Experience Requirements
• Bachelor’s Degree in Biochemistry, Chemistry, Chemical Engineering, Biotechnology, Biochemical Engineering with at least 6 years of relevant experience or Master’s Degree with 4 years of relevant work experience or a PhD with at least 2 years of work experience 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 cGMPs
Key Skills and Competencies
• Strong technical knowledge and expertise in process understanding and application in biopharmaceutical processes with ability to coach junior manufacturing sciences engineers
• Strong analytical skills including systematic evaluation of potential issues, correlation or cause and effect relationships and establishment of strategic goals and priorities for assessment
• Strong communication, stake holder management and conflict resolutions skills
• Willingness to learn
• Team worker/ able to work in matrix environment
• Independent worker/ Self starter