Biologics Production - Executive
Biologics Production - Executive
Posted on :
09-04-2025
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1 Vacancy
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Job Description
Job Summary:
The Executive in the Biologics Production Department will play a crucial role in the manufacturing and production of biologic 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 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 crossfunctional 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 scaleup process validation and equipment qualification.
- Support investigations of deviations outofspecification (OOS) results and nonconformances 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 costsaving measures.
- Stay updated on industry trends regulatory requirements and technological advancements in biologics production and propose and implement relevant improvements.
Qualifications and Skills:
- Bachelors or Masters 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 scaleup and technology transfer in biologics manufacturing.
- Strong analytical and problemsolving 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 crossfunctional teams.
- Proficiency in using manufacturing systems (MES) and other productionrelated software.
- Flexibility to work in shifts including weekends and holidays as required in a biologics production environment.
Employment Type
Full Time
Key Skills
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