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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

This position leads the group that is the interface between Analytical development and commercial QC. The Sr. Manager will be responsible for managing a group of scientists and subject matter experts responsible for supporting the design of method validation and method transfer protocols, executing protocols, and then transition of methods to the appropriate QC department for routine use. This group is also responsible for training and cross-training of all analysts in QC on existing assays to ensure a robust and flexible QC workforce.

Responsibilities

Lead and manage the QC Interface organization, ensuring effective collaboration between Analytical Development and Commercial QC for successful method transfer and validation.

Provide strategic oversight for the design, execution, and approval of method validation and method transfer protocols, ensuring methods are scientifically sound, fit for purpose, and compliant with regulatory requirements.

Ensure timely and effective transition of validated methods into the appropriate QC departments for routine use.

Own and continuously improve the QC training and cross training program, including accelerated onboarding for new hires and employees moving into new roles; monitor and improve training effectiveness metrics.

Establish and maintain clear, consistent communication between Development and QC validation teams to strengthen scientific collaboration, alignment, and mutual accountability.

Ensure validation activities are completed as planned and associated training needs are identified and addressed.

For new method transfers, lead cross functional scientific discussions to evaluate analytical strategies from multiple perspectives and determine the optimal path forward.

Critically assess the use of compendial (e.g., USP) methods and advocate for Emergent or alternative methods when they are more efficient, robust, equipment appropriate, and fit for purpose.

Evaluate the existing analytical methods and drive method improvement initiatives where opportunities are identified.

Partner with Global LIMS to plan and execute initiatives such as Laboratory Execution Systems (LES), paperless workflows, and other QC system efficiencies.

Enable data transfer to JMP and other analytics tools to support trending, statistical analysis, and identification of assay performance trends and improvement opportunities, working with internal partners and external consultants as needed.

Mentor, develop, and empower Supervisors to make timely, fair, and effective decisions related to staffing, performance, and resource management.

Advocate for change by identifying issues and driving data based solutions rather than simply highlighting problems.

Coach leaders and employees through complex technical, operational, and people management challenges requiring judgment and analysis of multiple factors.

Provide ongoing performance coaching, feedback, and development planning; act as a trusted advisor to the organization to resolve issues and achieve business objectives.

Provide development opportunities to staff through training, development plans, participation in appropriately challenging activities and applying leadership architect concepts.

Work in collaboration with Sr. Director, subordinates, internal customers and other cross functional peers to gain alignment on sound quality decisions.

Support workforce diversity, safety and adherence to company core values.

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

Education, Experience & Skills

PhD in a relevant scientific discipline and industry experience preferred

OR

Master’s degree with extensive experience in analytical method development, validation, and regulated QC environments.

Minimum 12 years of progressive experience in analytical sciences, quality control, method transfer, and/or validation within a regulated environment.

Demonstrated senior leadership experience managing scientific teams, complex programs, and cross functional stakeholders.

Strong scientific judgment, strategic thinking, and ability to influence decisions across multiple organizational levels.

Proven ability to drive change, build high performing teams, and deliver results in a highly regulated, fast paced environment.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .