Lead Scientist, AS&T

Emergent Biosolutions • Canton, MA

3d • $150,000 - $176,000

About The Position

The Lead Scientist, AS&T supporting QC Method Lifecycle Development will be responsible for providing leadership, management, and oversight to QC method development, transfer, qualification, verification and validation activities, QC Equipment Qualification and Administration, review method performance and data trending, manage QC reference standards and controls, and lead relevant QC Projects and Investigations. The manager will provide SME support at the Canton site and maintain test methods and instruments in a compliant state.

Requirements

• Must have at least 10 years of relevant experience or MS with a minimum of 8 years of relevant experience.
• Must possess skills and knowledge of general immunological, bioanalytical and chemical test methods such as ELISA, qPCR, IEF, Viral and Cell-based assays, SDS-PAGE, Western Blot, DNA sequencing, microbiological methods, Sterility testing, Endotoxin testing, HPLC with multiple modes of detection, CE, and UV and IR spectroscopy.
• At least 5 years prior Management experience required.
• Advanced knowledge of USP/EP, cGMPs, 21CFR part 11, and data integrity.
• Experience in executing phase appropriate method qualifications and validations.
• Experience in assay method validation, equipment validation, and analytical investigation for biotherapeutic and vaccine products.
• Ability to apply statistical analysis to QC monitoring and trending

Responsibilities

• Oversees and manages the QC activities involved development, transfer, qualification, verification, and validation of test methods. These include working with internal and external clients to draft/review/approve protocols and reports, and to create timelines and schedule resources and activities.
• Provides technical expertise for method development/optimization, verification, qualification and validation. This includes analyzing and interpreting data, investigating analytical problems and work with clients to develop approaches to rectify those problems as needed.
• Ensures QC equipment compliance to USP<1058> and 21CFR211 part 11. Performs site Administrator role for QC equipment and LIMS.
• Interact with contract, corporate, and governmental agency representatives and auditors. Regularly present to and interact with senior management to set and modify goals, budget and operations related to the functional area.
• Preparation and oversight of methods, protocols, trend reports and summaries for cGMP testing as required.Create and update schedules and presentations as needed; participate in departmental senior staff meetings and decisions.
• Review current laboratory practice to identify alternative strategies or cost saving measures for laboratory improvement.
• Provides scientific review and approval of protocols, reports, study design and standard operating procedures.
• Performs managerial duties, as assigned, in support of QC operations such as resource management and failure investigation review.
• Investigate, troubleshoot, and resolve test method and QC equipment deviations and CAPAs. Provide SME support as needed

Benefits

• Eligibility for additional incentive compensation, including merit increases, annual bonus, and/or long-term incentives in the form of stock options.
• Comprehensive benefits package

What This Job Offers

• Job Type: Full-time
• Career Level: Senior