Biologics Production
2 months ago
**Job Summary**:
The Executive in the Biologics Production Department will play a crucial role in the manufacturing and production of biologic drugs in Promea. They will be responsible for ensuring the efficient and compliant production of biologics, adhering to quality standards, safety regulations, and production schedules.
**Key Responsibilities**:
- Execute and oversee the manufacturing operations of biologic drugs, including upstream and downstream processes, purification, and formulation.
- Ensure compliance with current Good Manufacturing Practices (cGMP) and standard operating procedures (SOPs) in all production activities.
- Prepare and review production documents, batch records, and production reports, ensuring accuracy, completeness, and compliance with regulatory requirements.
- Collaborate with cross-functional teams, including process development, quality control, and engineering, to optimize production processes and troubleshoot any technical issues.
- Monitor and analyze production data, yield trends, and key performance indicators (KPIs) to identify areas for improvement and implement corrective actions.
- Participate in technology transfer activities, including process scale-up, process validation, and equipment qualification.
- Support investigations of deviations, out-of-specification (OOS) results, and non-conformances, and assist in implementing appropriate corrective and preventive actions (CAPAs).
- Ensure proper documentation and maintenance of equipment, production areas, and production records in accordance with cGMP guidelines.
- Contribute to continuous improvement initiatives, suggesting process enhancements, efficiency improvements, and cost-saving measures.
- Stay updated on industry trends, regulatory requirements, and technological advancements in biologics production, and propose and implement relevant improvements.
**Qualifications and Skills**:
- Bachelor's or Master's degree in Biotechnology, Biochemistry, or a related field.
- Solid understanding of biologics production processes, including cell culture, fermentation, purification, and formulation.
- Familiarity with cGMP guidelines and regulatory requirements specific to biologics manufacturing.
- Experience with bioreactors, chromatography systems, filtration technologies, and other equipment used in biologics production.
- Knowledge of process optimization, scale-up, and technology transfer in biologics manufacturing.
- Strong analytical and problem-solving skills, with attention to detail and the ability to analyze complex data sets.
- Excellent organizational and time management abilities, with the capability to manage multiple priorities and meet production schedules.
- Effective communication and interpersonal skills, with the ability to collaborate and work effectively in cross-functional teams.
- Proficiency in using manufacturing execution systems (MES) and other production-related software.
- Flexibility to work in shifts, including weekends and holidays, as required in a biologics production environment.
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