Technical Services Manager (Fixed-Term Contract)応募 後で応募 求人ID R0013614 掲載日 11/01/2019 Location:Singapore, Singapore
- To lead the technical services team with the focus on live attenuated and inactivated viral vaccines.
- To supervise technical service scientists responsible for process technology transfer to CMO sites pertaining to clinical Vaccine Manufacturing.
- Oversee technical aspect of any CMC project transfer to 3rd party contractors.
- To establish, optimize and qualify manufacturing methods for the manufacturing at CMO.
- To supervise in-process testing scientists to ensure timely analytical testing of samples generated in Singapore Laboratory.
- Lead the team for the transfer of analytical assay into Singapore for the various vaccines programmes.
- Oversee team in managing programs conducted by both in-house employees and at 3rd party vendors
- Responsible for new product technology transfer, process qualification and validation activities at 3rd party CMO.
- Responsible for managing contract manufacturing and testing organizations (CMOs and CTOs) to achieve CMC projects deliverables within the specified timeline.
- Responsible for the timely generation of analytical assay results, to support the process development group, to achieve the overall CMC goals.
- Develop and manage strategies for Technical Services infrastructure, resource, project, outsourcing, etc. in conjunction with management team within CMC Singapore.
- Develop, drive, set vision and direction for Technical Services activities.
- Responsible for technical project strategies, planning and execution of deliverables.
- In charge of technology transfer of new development programme, to advance the Company's portfolio pipeline.
- Responsible for recruiting, mentoring and evaluating personnel to ensure effective operations of the technical services group.
- Responsible for supporting investigations originating from deviations of GMP runs during clinical manufacturing runs.
- Responsible for interacting with regulatory affairs colleagues to ensure timely submission of CMC regulatory documentation to the appropriate authorities.
- Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities.
- Conducts performance review and drive goal setting and development planning.
EDUCATION, EXPERIENCE, SKILLS:
- BSc/MSc (with relevant experience) or PhD in life sciences or closely related field
- At least 8 – 10 years of applicable experience
- Biologics technology transfer experience required; experience in vaccines would be an advantage
- Experience/knowledge of cGMP practices as applicable to upstream/downstream virus manufacturing processes, process development and/or technology transfer is desirable
- Knowledge and experience of working in a biologics regulatory environment
- A thorough knowledge of Good Documentation Practices (GDP)
- Demonstrate leadership in managing a high performing team consisting of highly motivated senior scientists and scientists
- Superior communication, strategic,interpersonal and negotiating skills
- Ability to proactively predict issues and solve problems
- Ability to drive decision-making within a multidisciplinary, multi-regional, matrix team
- Diplomacy and positive influencing abilities
- Comply with Takeda safety practices and standard operating procedures
- Exhibit and promote Takeda Core Competencies
- Local and/ or overseas training attachment may be required
- Fixed Term Contract
- May require some international travel, approximately 5 - 20%