Senior Scientist, Manufacturing (Biopharmaceutical, Remote)

Job summary

The role involves supporting the manufacturing process of biopharmaceuticals, ensuring compliance with GMP standards, and facilitating real-time problem-solving during production. The Senior Scientist will act as a critical link between process understanding and execution on the shop floor.

Qualifications

• Academic degree in Life Sciences or related fields.
• Minimum of 5 years of experience in a manufacturing environment under cGMP, preferably in the pharmaceutical sector.
• Knowledge of upstream and/or downstream processes.
• Experience in writing, reviewing, and approving GMP documentation is preferred.
• Familiarity with single-use technologies and aseptic processing is advantageous.

Responsibilities

• Create and review Master Production Records.
• Provide on-call support during critical production steps.
• Facilitate solutions during production breakdowns.
• Ensure timely closure of deviations and quality documents.
• Maintain compliance procedures and support audits and inspections.
• Capture learnings and implement continuous improvements.

Skills

• Strong organizational and proactive problem-solving skills.
• Ability to coordinate tasks across multiple departments.
• Excellent communication skills for interaction with stakeholders.
• Experience in leading troubleshooting efforts and managing multiple projects simultaneously.

Education

• Master's or Bachelor's Degree in natural or life science related fields.

Tools

• Familiarity with GMP documentation and manufacturing technologies.