Job Description

The LMAS Critical Reagents Associate Director will provide technical leadership and implementation support for qualification activities, key projects, and strategic initiatives to enable the optimal execution and continuous improvement of activities across the critical reagent life cycle. This role will closely partner with local site and global stakeholders such as analytical testing labs, analytical method owners/developers, statisticians, and regulatory functions to progress work in alignment with functional and product franchise priorities. A key responsibility of this role is to ensure fit-to-purpose technical rigor of reagent evaluations and critical reagent knowledge management through peer coaching. This position will be expected to help drive effective strategies and achieve optimized utilization of analytical assets to control speed of testing, quality standards, and costs for reagent supply and evaluation. Given the scope, this role requires strong understanding of critical reagent QMS and business practices as well as technical expertise in general analytical laboratory operations, equipment, and techniques.

Effective communication and teamwork with internal and external partners is essential to the success of this role. The ideal candidate for this position will have a strong working knowledge of QMS requirements for change control and management of GMP data/documents as applied in a QC laboratory or analytical support function. This role will require strong communication and collaboration skills as well as the technical training or work experience demonstrating capability to drive project completion with the technical competencies in analytical platforms and data analysis. Critical thinking and planning/organizational skills to ensure effective communication with stakeholders (within and beyond Large Molecule Critical Reagents organization) is required. Additionally, the candidate will be responsible for technical problem solving and work prioritization/sequencing choices that protect immediate and long-term reagent quality and product supply. This is a newly defined role that will initially focus on ensuring standardized and scalable processes and capability to support the growing portfolio of critical reagents. This role will also strive to optimize legacy vaccine qualification practices while being aligned with approved capital investments for enhanced operational and digital capabilities. The ideal candidate will bring a positive and resilient mindset to lead the organization through this transformative change.

As a LMAS Critical Reagents Associate Director for Large Molecule Critical Reagents, this role is accountable for the design and execution of project-based and complex activities supporting the critical reagent lifecycle, including new reagent introduction, and existing reagent risk mitigation.

Job Profile:

• Provide leadership and direction for formal critical reagent projects and qualification activities that will include cross-functional support from BCR scientists, testing laboratories, LMAS scientists, CMC Regulatory, as well as AR&D scientists
• This can include the design of new data collection techniques and procedures, leading complex problem-solving initiatives, comprehensive implementation of updated or revised technical analysis & reporting, as well as implementation of new protocol-driven reagent studies in accordance with QMS and protocol requirements (includes design of new recertification, qualification, and stability focused protocols)
• Monitor progress and support completion of above work activities by target dates as per Large Molecule (LM) Critical Reagents S&OP process and aligned cross-functional integrated work plans (issued/approved by the LM Critical Reagent Planning and Controls team and based on collaboratively established, realistic standard lead times for core work activities). Rapidly escalate and resolve issues through tier process. Encourage team culture of transparency, support, and accountability.
• Ensure characterization/qualification testing plans and acceptance criteria are technically sound and aligned with acceptable business risk per the process/analytical combined product control strategy. Apply combined knowledge of theoretical understanding and as-implemented practices (such as physical handling, testing laboratories business practices) to challenge and optimizeexisting procedures and identify continuous improvement options.
• Participate in hoshin and MPS processes to establish principles and prioritized actions to continuously improve critical reagent activities, including opportunities to improve the rigor of reagent characterization, consistency of reagent performance, reliability of BCR supply, and/or business process efficiency.
• Collaboratively develop and maintain standard process to capture and communicate key reagent risks with LMCR LT
• Foster collaboration and strong network connections across LMAS, QC, and other process/analytical partners. Support product decision-making forums (such as APLC Steering Committee, Analytical Working Groups, Technical Product Council) and ensure critical reagent team contributes to and is informed of product strategies.
• Participate in LMAS project portfolio process and enforce good project management practices across team. Prioritize and complete sanctioned project work according to aligned project plans.
• Partner with LM Critical Reagents areas and other stakeholders to support new reagent introduction activities, including establishment and maintenance of new critical reagent processes to meet evolving expectations (for example, product-specific reagent monitoring commitments).

Minimum Education and Experience Required:

• Bachelor of Science (BS) degree level in a science or applied field that establishes technical foundation for analytical work (such as but not limited to chemistry, biochemistry, biology, microbiology, engineering) with seven (7) years combined experience in an analytical support function including development, commercialization, and/or Quality Control roles. OR
• Master of Science (MS) degree level in a science or applied field that establishes technical foundation for analytical work (such as but not limited to chemistry, biochemistry, biology, microbiology, engineering) with five (5) years combined experience in an analytical support function including development, commercialization, and/or Quality Control roles.

Required Experience and Skills:

• Direct or indirect leadership responsibilities demonstrating effective collaboration, listening skills, personnel coaching, and ability to influence decisions across organizational levels
• Familiarity with GMP analytical laboratory operations, analytical test methods, and LIMS
• Direct experience executing GMP change control and supporting GMP deviation management practices, including 8-step investigations
• Able to work independently, with guidance in only the most complex situations.

Preferred Experience and Skills:

• Prior experience supporting critical reagent lifecycle activities
• Lean/six sigma or internal company MPS experience, such as process mapping and value stream mapping, or other demonstrated ability to improve business processes and/or apply currently available digital tools.
• Experience participating in or leading QRA or other risk assessments
• Excellent presentation, oral and written communications skills: ability to simplify complex situations to clear, focused, fit-to-purpose communication with target audience.
• Experience supporting strategy or technical content for regulatory submissions/communications
• Demonstrated willingness to learn new areas, seek-to-understand and continuously improve mindset, and ability to rapidly acquire working competency in adjacent or new areas to drive positive change.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Job Posting End Date:10/06/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R316055