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Director, Quality Control Protein Sciences
THIS JOB HAS EXPIRED
Job DescriptionThis key position is responsible for developing and executing short and long term goals of the QC laboratory efforts in support of IND, BLA and commercial products and milestones. Constructively manages staff to achieve goals and develop capabilities. Participates in teams with intellectual honesty, insight and a supportive manner. Effectively anticipates and communicates issues and takes action as required. Performs all activities in compliance with GMPs, SOPs, corporate policies and the highest ethical standards.
PRIMARY ACCOUNTABILITIES
1. Oversees component and finished product stability program, transfer of validated methods to routine use, and participation of QC staff in support of validation of methods and equipment. Ensures all testing is performed with minimal repeats and in a rigorous manner consistent with the expectations of a commercial product and defined timelines.
2. Directs QC staff and daily operations to include: release and stability testing, in-process testing, QC documentation, equipment maintenance and calibration and QC laboratory design and maintenance.
3. Provides coaching, mentoring, and development of staff
4. Oversees component and finished product stability program, transfer of validated methods to routine use, and participation of QC staff in support of validation of methods and equipment.
5. Establishes and directs QC control programs.
6. Manages GMP material control program to include: QC materials management including labeling and storage, QC materials inventory and use and materials lot control. Oversees component and finished product stability program, transfer of validated methods to routine use, and participation of QC staff in support of validation of methods and equipment.
7. Reviews and approves reports and other documentation for regulatory submissions as assigned.
8. Represents QC in interactions with customers, other PSC organizational units, audits, and regulatory inspections.
9. Assists in troubleshooting assays
10. Monitors laboratory systems and operations to ensure lab operates efficiently and effectively
11. Responsible for other topics as assigned
Requirements
1. Bachelors degree in science; advanced degree preferred and at least 10 years of biopharmaceutical experience with at least 6 years in a leadership role within quality control.
2. Recombinant protein/biologics experience preferred.
3. Must be well organized and able to effectively span the requirements of a small company QC organization.
4. Demonstrated critical analytical and evaluation skills.
5. Communicates effectively in English (written and verbal)
6. Training in quality control methodologies, i.e., control charting, investigations, etc.
7. Experience in commercial operations and regulatory health inspections a plus.
8. Experience in regulated (GMP) quality control operation
| Location: | 1000 Research Parkway Meriden, CT 06450 United States |
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THIS JOB HAS EXPIRED
Protein Sciences
Investors: Pacific Rim PartnersAll Jobs: at Protein Sciences
| Web Site: | www.proteinsciences.com |
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| Headquarters: | 1000 Research Parkway Meriden, CT 06450 United States |
| Industry: | Biotechnology |
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