Job Description

The Position Function: MSAT Reports to: Head of MSAT Purpose The Site Transfer Lead is responsible for planning and execution of all product tech transfers in and out of the site. They will develop and ensure adherence to established transfer plans, timelines and budgets. Additionally, they are responsible for representing the site at a global level through leadership and participation of Network related tech transfer initiatives. This position resides within the Manufacturing Science and Technology (MSAT) organization, which is accountable for the implementation and maintenance of manufacturing processes and systems enabling the manufacture and release of protein therapeutics. Key Responsibilities

• Identify, plan, and execute product related transfer activities into the manufacturing site.
• Execute facility fit assessments to identify gaps for new manufacturing processes.
• Lead gap closure remediation efforts to identify facility modifications required for new processes.
• Oversee new product introduction requirements including business process logistics, master batch records, recipes, SOPs, risk assessments, and gap analysis.
• Liaise with site and global functions ((ie Regulatory, Development, Supply Chain, and other sites) to ensure activities related to transfer are delivered per stated timelines.
• Lead the Site Transfer Team and serve as a standing member of related Network transfer team(s).
• Author, support, and review regulatory filings as needed.
• Support FDA/Regulatory/internal compliance and licensure inspection activities.
• Collaborate with other departments to address issues and meet deadlines
• Serve as member of the MSAT leadership team, contributing to the development and execution of strategic initiatives

Work Environment:

• This position is eligible for Flexible Work Agreements per current site policies and procedures. Current policies do require that the majority of time be spent working from an onsite office (Tuas).
• As this role requires collaboration with colleagues in multiple time zones (Singapore, Europe, United States), participation in virtual meetings outside of normal business hours is required.

Safety, Health & Environment:

• Comply with all RSTO\xe2\x80\x99s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
• Implement, enforce and take ownership of all RSTO\xe2\x80\x99s Safety, Health & Environmental (SHE) requirements and initiatives within his/her areas of responsibilities.
• Ensure all employees are competent and provided with the necessary tools and equipment to work safely and without health risks.
• Observe all RSTO\xe2\x80\x99s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.

Lean Production System:

• Embody PT Lean Production System (LPS), while fostering and advocating a continuous improvement mindset and culture throughout the organization, by encouraging experimentation and learning.

Qualifications

• B.S or M.S. in Mechanical Engineering, Chemical Engineering or Electrical Engineering or equivalent degree and relevant work experience/training.
• Minimum 10 years of related experience in Pharmaceutical Manufacturing.
• Experience with cell culture and/or purification technical development or process engineering is preferable.
• Proven project management skills and experience, including financial planning.
• Candidate must be able to work well with others as a team member in an informal results-oriented work environment.
• Candidate must have good communication skills (both verbal and written).
• Candidate should have a good understanding of Current Good Manufacturing Practice (cGMP), particularly as they relate to manufacturing process design, qualification, and execution.

Who we are At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we\xe2\x80\x99ve become one of the world\xe2\x80\x99s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. Roche is an Equal Opportunity Employer.