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:

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

Requirements:

1. Bachelor’s degree in Bio/Chemical Engineering, Life Sciences, Biology, Chemistry, or related field.
2. 3 to 6 years of relevant experience in biologics or vaccine manufacturing.
3. In-depth understanding of cGMP practices for fill-finish operations.
4. Strong problem-solving skills, attention to detail, and team collaboration.
5. 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 alex.fong@AlwaysHired.com.sg

We regret to inform that only shortlisted candidates will be notified.