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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

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Job Description

OBJECTIVES:

  • 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

ACCOUNTABILITIES:

  • 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

TRAVEL REQUIREMENT:

  • May require some international travel, approximately 5 - 20%

Locations

Singapore, Singapore

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

応募 後で応募