Lead Scientist, AS&T

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life‑saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.

JOB SUMMARY

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.

ESSENTIAL FUNCTIONS

Oversees and manages the QC activities involved in 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 working with clients to develop approaches to rectify those problems as needed. Ensures QC equipment compliance to USP 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. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws. BS degree with at least 10 years of relevant experience or MS degree 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 U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $150,000 to $176,000. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, and/or long-term incentives in the form of stock options. Additionally, Emergent offers a comprehensive benefits package. Information regarding additional benefits can be found here: (* Eligibility for benefits is governed by the applicable plan documents and policies). #J-18808-Ljbffr Emergent Biosolutions