■ Maintain CMC manufacturing records and documentation (authoring and reviewing technical reports, protocols, technology transfer documents, CMC sections in regulatory filings, TRDs)
■ Supporting technology transfer and process development to cGMP manufacturing, site transfers of commercial manufacturing processes as required
■ Providing ongoing technical support for change control, deviation investigations and CAPA management as required during development and commercial manufacturing of products
■ Ensure transfer of knowledge within the global production network: data evaluation and sharing between sites; exchange of process optimization opportunities and regular
■ Provide process and product expertise and solutions in global trouble shootings
■ Execute activities in support of global life cycle initiatives
■ Act as local key contact partner for Manufacturing Science and Technology (MSAT) Biotech organization
WHO YOU ARE
■ University Degree (Preferably in pharmacy)
■ 8 + years relevant experience in Chemical, Biomedical, Industrial Engineering etc. plus Production and / or Engineering experience in the Pharmaceutical industry
■ 3-5 years of working experience with cGMP, international guidelines and regulations with knowledge of systems and standard documentation required in the pharmaceutical industry.
■ Experience in support of launch, tech transfer, and / or sustaining cGMP commercial drug product manufacturing process operations in biopharmaceuticals
■ Experience / technical knowledge with drug product manufacturing required (ie formulation, aseptic filling, lyophilization)
■ Knowledge of process validation requirements
■ Knowledge of cGMP regulatory guidelines
■ Good technical writing skills
■ Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions
■ Fluent in Japanese and English
■ Able to lead teams and promote team approach, to motivate, and to resolve conflict
■ Strong ability to plan and prioritize complex activities
■ Strong analytical skills to identify risks and prepare balanced decisions
■ Ability to troubleshoot and make quick, knowledge and experience guided decisions
・ Building partnerships and working collaboratively with others to meet shared objectives.
・ Making sense of complex, high quantity, and sometimes contradictory information to effectively solve problems.
・ Planning and prioritizing work to meet commitments aligned with organizational goals.
HOW TO APPLY
Please apply for the position through our recruiting website with Japanese resume, Japanese working experience and English CV.
Please find other working conditions at our career site, by coping and pasting the following URL on your internet browser.
Expected recruitment date: ASAP
Department: Prescription drugs Work location: Shiga
Job area: Job grade of production position: VS1.2 ~ 1.3
Employee classification: Full-time employee Working hours: 08: 15-16: 45