Overview:
Tasked with overseeing the production of biologics, conducting operations in production facilities to facilitate downstream manufacturing in accordance with current Good Manufacturing Practices (cGMPs).
Responsibilities:
- Prepare instruments, conduct downstream purification processes, and perform clean room tasks adhering to cGMP standards under supervision.
- Execute procedures outlined in GMP documentation, including SOP/MBR, and promptly communicate with the internal team regarding floor activities, escalating issues to supervisors when necessary; Document deviations from SOP/MBR requirements.
- Participate in deviation investigations and the implementation of Corrective and Preventive Actions (CAPAs).
- Maintain cleanliness in the clean room as per cGMP requirements, including equipment surface cleaning, periodic cleaning, and changeover cleaning.
- Assist supply chain and Engineering teams with equipment validation, calibration, and maintenance.
- Utilize support systems such as LIMS as needed during GMP production.
- Perform job-specific tasks in compliance with Regulations, International Standards, and Policies.
- Promote and practice safe work habits, adhering to safety procedures and guidelines.
Requirements:
- High School Diploma/GED or College Degree
- Previous experience in the Pharmaceutical industry preferred
- Prior experience in bulk biologics cGMP manufacturing is advantageous.
- Experience working in a manufacturing environment
- Familiarity with TFF skids, centrifuges, chromatography columns and systems, and/or UF/DF systems preferred.
- Strong communication skills, teamwork abilities, and capacity to foster positive collaborations with internal stakeholders, vendors, and clients to achieve common goals effectively.
- Must demonstrate self-motivation, flexibility, organization, and attention to detail.