Lead Manufacturing Expert

**Company Profile**:
Takeda's Singapore biologics manufacturing facility focuses on manufacturing potentially life-saving medicines for patients suffering from rare blood disorders such as Hemophilia A and B. As part of the company’s Biologics Operating Unit network, the site is Takeda’s only biologics drug substance manufacturing facility in Asia. The facility has two buildings, including manufacturing suites and laboratories, as well as Takeda’s first positive energy building certified by Singapore’s Building and Construction Authority’s Green Mark scheme in 2022.

**Job Title: Lead Manufacturing Expert**
**Location: Woodlands, Singapore**

**About the role**:
The individual will work, independently with regular reporting the line manager, to support and coordinate routine GMP manufacturing life cycle and day to day operational activities associated with the products and process equipment in Takeda Singapore, including but not limited to Suite 1 Manufacturing, Suite 2 Manufacturing and Manufacturing Support areas. In addition, the individual will provide lead key initiatives not limited to continuous improvement, validation and CAPEX activities.

**How you will contribute**:
The individual will support the EHS and cGMP compliance of day to day and tactical manufacturing activities and ensuring production activities are executed successfully. Primary responsibilities include: (70%)
- Work hand-in-hand with the shift teams to ensure adherence to the production plan, resolve issues, as required
- Be considered to have more than one area of manufacturing expertise, for example, Upstream processing/Downstream processing/ Equipment Preparation/ Buffer Preparation and/or knowledge in key systems like EBM/XFP/CIP/SIP knowledge
- Carry out deviations investigations in the GEMS system, including product impact assessments and implement CAPAs
- Be a change control owner in the CCMS system, if applicable
- Maintain recipe configuration management documentation, if applicable
- Carry out material support activities including liaising with MLCM or vendors to address material issues, if applicable
- Develop and implement CAPAs arising from audits
- Informing management of events impacting production schedule - Propose and review document revisions
- Carry out work in a safe manner, notifying management of safety issues and risks

The individual will manage equipment and support facility related projects by: (20%)
- Assist in audit preparation as well as documentation related to audit responses, Adverse event notification review and Annual Product Reviews, as required
- Lead the transfer/implementation of new processes and commissioning & validation activities of new projects
- Lead complex investigations
- Lead continuous improvement
- Lead product change over activities
- Monitor and analyze processing parameters for atypical trends and improvement opportunities
- Act as a department training coordinator as required

Staff Technical Training and Development: (10%)
- Meet and maintain training requirements on time
- Provide technical training for area personnel, as required
- Develop training material, as required
- Train and coach team members, as required
- Develop and maintain personal development plan
- Participate in site or global strategic initiatives, as required
- Provide feedback to peers to help staff development, as required
- Provide annual performance self-assessment on development plan

Others:

- Responsibility to adhere to any applicable EHS requirements.
- Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.
- Any other duties as assigned by supervisor.

**What you bring to Takeda**:
Education and Experience Requirements
- Degree in Chemical Engineering / Bioengineering / Chemical & Biomolecular Engineering / Pharmaceutical Engineering or related and possesses 7 years of relevant experience in the biotechnology or pharmaceutical industry
- Diploma in Applied Chemistry / Biomedical Sciences / Chemical Engineering / Food Science & Technology / Biologics & Process Technology / Chemical & Pharmaceutical Technology/ Food Science & Nutrition / Molecular Biotechnology / Biotechnology / Chemical & Biomolecular Engineering / Pharmacy Science or related and possess years of relevant experience in the biotechnology or pharmaceutical industry
- Nitec in Biotechnology / Chemical Process Technology or related with 12 years of relevant experience in the biotechnology, pharmaceutical industry
- Excellent self-motivated team player with hands-on attitude and excellent communication skills
- Able to work on odd hours as required

Key Skills and Competencies

The individual should have good understanding of cGMP manufacturing aspects and had hands-on manufacturing experience.
- Excellent at technical writing as required for Electronic Batch Management (EBM), Batch Records (MBRs, MFRs) and Standard Operating Procedures (SOPs).
- Possess good communication and