Downstream Manufacturing Manager
1 week ago
JOINN Biologics is seeking a highly skilled Downstream Manufacturing Manager to oversee the day-to-day operations of our downstream manufacturing processes. As a key member of our team, you will be responsible for ensuring the delivery of customer commitments while maintaining the highest standards of quality and compliance.
Key Responsibilities:- Management and execution of downstream operations, including solution preparation, purification, viral inactivation, filtration, and formulation and filling operations.
- Training and development of downstream team members in downstream operations.
- Planning and coordination of daily, weekly, and monthly downstream execution activities.
- Ensuring batch records, standard operating procedures, and Current Good Manufacturing Practice (cGMP) regulations are rigorously followed.
- Active troubleshooting and assessment of current process efficiencies to minimize risks and promote continuous improvement.
- Planning and management of raw materials and consumables for production campaigns.
- Reporting and documentation of non-conformities and participation in investigations and creation and implementation of corrective/preventive actions.
- Minimum of 5 years of experience in downstream process manufacturing with 2 years of supervisory experience.
- Expertise in downstream unit operations.
- Strong hands-on experience with Chromatography and filtration systems.
- Exposure to handling of recombinant proteins and biotherapeutics projects in cGMP area.
- Sound knowledge and awareness of GMP controls, Quality systems, and regulatory aspects.
- Strong technical writing skills.
- Proven problem-solving skills and quick decision-making abilities.
- Exceptional communication skills.
JOINN Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
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