Process Biotechnologist (Fill-Finish, Vaccine)

Location: Singapore
Budget: Up to $7,000

Overview:
The successful candidate will act as the user representative and area owner during the technical transfer of processes and products from R&D and CMC to GMP clinical manufacturing, focusing on fill-finish processes for various modalities and platforms.

Key Responsibilities:

• Represent the user area during the technical transfer of new products and processes, ensuring compliance with GMP standards.
• Execute and oversee manufacturing activities involving fill-finish equipment, including troubleshooting and maintenance.
• Provide input and author technical documentation such as SOPs, batch records, and facility assessments.
• Collaborate with cross-functional teams to coordinate project activities and meet timelines.
• Support qualification and validation efforts for process and equipment.
• Act as an SME during regulatory audits, presenting expertise on fill-finish operations.
• Record data accurately following ALCOA principles and uphold Good Documentation Practices (GDP).

Requirements:

• Bachelor's degree in Bio/Chemical Engineering, Life Sciences, Biology, Chemistry, or related field.
• 3 to 6 years of relevant experience in biologics or vaccine manufacturing.
• In-depth understanding of cGMP practices for fill-finish operations.
• Strong problem-solving skills, attention to detail, and team collaboration.
• Experience with plant start-up or commissioning in a biotech environment is a plus.

Interested candidates please apply online or send your latest CV to

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