DS SME Singapore

Drug Substance SME

Scope of Responsibilities

• Engineering design support for mAbs Process which may include
  • Process equipment incl SU Bioreactors chromatography and TFF skids
  • Buffer and Media Prep systems incl. filling stations vessels and transfer lines
  • CIP skids and distribution.
  • Central Dispensing and Logistics for DS activities
  • Support / coordination for DS Process utilities

Key Responsibilities

• Work closely with the Designers ( Exyte & Pharmadule Morimatsu ) to develop the design translating technical requirements into the agreed engineering deliverables.
• Work closely with the site operations team and global support such as GTO (as necessary) to have an aligned position on critical technical areas and communicate with Exyte design team in a single unified manner
• Attend all necessary design discussions provide technical direction on requirements and drive a risk-based design to cost ethos into the design decision-making process for your areas of responsibility
• Coach and support Exyte design team to develop User Requirement Specifications (URSs) that are technically complete (eg. CTQs GMP GEP and SHE requirements) technically correct and appropriate for C&Q execution
• Review and approve all URSs within technical area as Engineering SME Approver (engineering requirements)
• Review and comment on assigned engineering deliverables produced by Exyte & equipment suppliers.
• Attend supplier visits for critical equipment packages (on as required basis)
• Carry out periodic Design Assurance reviews and reporting (306090%) to ensure ongoing technical alignment and identification of value engineering opportunities.
• Provide technical support to SHE risk assessments (HAZOPs SWIFT LOPA studies etc.) and ensure key risks are identified and appropriate mitigations are included in the design.
• Work collaboratively with assigned Work Package Owners to ensure the technically compliant delivery of equipment packages Attend supplier visits for critical/ancillary equipment packages (depending on geography and carbon budget considerations)
• Participate in and make recommendations for the procurement strategy for technical work packages including pre-qualification/contractor selection and technical content/scope of contracts.
• Review and comment of BD Design Deliverables within required review periods ( with support as required from GTO SME)
• Review and approve DQ protocols for critical equipment packages as they become available
• Ensuring SHE considerations sustainability targets relevant SME engagement and applicable standards are incorporated into proposed solutions
• Work collaboratively with assigned Work Package owners and C&Q partners to ensure the technically compliant delivery of equipment packages.

In addition to SME duties start to pick up the responsibilities as mAbs SME for the project as GTO support is curtailed in June down to an ad-hoc level from Q3 onwards