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Job Details

Location
Tokyo
Salary
Competitive Salary
Job Type
Permanent
Ref
BH-169959
Contact
Tom Tan
Contact email
Email Tom
Posted
12 days ago
Responsibilities
  • You, as The Senior Manager, API (Active Pharmaceutical Ingredient) Development, will be responsible for the development, optimization, implementation and management of robust, cost effective, and safe processes for the manufacture of small molecules including Oligonucleotide Active Pharmaceutical Ingredients (APIs).
  • You will be responsible for the technical development, support, development of innovative solutions and commercialization of drug substances using an external and internal network of providers.
  • You will provide technical oversight, expertise and guidance of drug substance related activities.
  • The scope of the role encompasses a wide breadth of lifecycle, ranging from early-stage development, late stage development, process validation, early commercial manufacturing, contribution towards CMC content for regulatory submissions, regulatory approval and product life cycle management.
  • The role will be critical in ensuring we optimize development, reduce risk profiles and ultimately accelerate the development cycle of assets.
  • You will be expected to manage these activities using an outsourcing model and to work within a cross-functional team environment of external service providers and internal team members to help define project scope and plan, and ensure successful delivery with regards to process development, technical troubleshooting, quality, compliance, milestone timelines and project budget.
  • Identify opportunities and activities that can enable the scale up of drug candidates for pre-clinical and clinical studies as well as supporting validation activities when progressing to late stage.
The successful candidate will report directly to the Director, Chemical Development based in the US.

Qualification And Job Requirements
  • PhD in synthetic organic chemistry with 5+ years of experience in pharmaceutical research and development in the biotech or pharma industry, with significant experience in the areas of process development, process characterization, process validation and product life cycle management or BS/MS with 8+ experience is required.
  • Demonstrated history working in a virtual CMC development and commercialization environment working with CMC partnerships with global providers.
  • Excellent written and oral communication skills, including the maintenance of technical data and reports; proactive collaboration a multi-disciplinary business and science team environment is essential.
  • Experience with control strategy development by either process characterization or design space studies using DoE or modelling tools.
  • First-hand experience in Oligonucleotide collaborations with medicinal chemistry, analytical, biology, toxicology, clinical pharmacology, Quality Assurance, Regulatory CMC and CMC development departments.
  • Must be able to determine appropriate resources for resolution of problems, to have strong organizational and planning skills and work independently.
  • Desire to acquire new knowledge in chemistry, pilot and plant operations in different contract research organizations.
  • Experience in preparation of CMC documents in support of global regulatory filings across development stages (e.g. IND to NDA).
  • Strong computer, scientific, and organization skills.
  • Ability to travel ~ 30% both domestically and internationally.
Reg No. R1109268
BeathChapman Pte Ltd
Licence no. 16S8112