Job Description
The BCR Sciences, Associate Director will lead a team responsible for the execution of critical reagent characterization and certification activities in accordance with quality system requirements and interim milestone dates per cross-functional integrated work plans. This role will have oversight of an assigned grouping of critical reagents spanning product families and modalities, with focus on technical/scientific rigor of critical reagent evaluations, sustainable knowledge management and standardization of approaches for similar reagents to improve reagent robustness and supply reliability. Key responsibilities include team management, metric tracking, and prioritization support to deliver on the reagent-specific integrated qualification work plan, performance monitoring, and reagent stability activities. This role will coach the team to proactively identify and mitigate critical reagent supply and/or performance risks through execution excellence and thoroughness of analysis during routine activities, maintenance of best practices within critical reagent protocols, and strategic project support.
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 coach and develop a high performing team with the technical competencies in analytical platforms and data analysis. Critical thinking and planning/organizational skills to guide the team and productively collaborate 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 BCR Sciences team leader for an assigned reagent collection, this role is accountable for the compliant and timely execution of activities supporting the reagent characterization and certification processes as well as management of associated risks:
- Data collection, technical analysis, reporting, and certificate of analysis for new reagent lot qualifications, existing lot re-evaluations, and protocol-driven reagent studies in accordance with QMS and protocol requirements.
- Monitor progress and support team to complete 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.
- Maintain critical reagent protocol content, including incorporation of standard best practices. 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.
- 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.
- Develop and maintain agency-approved comparability protocols, as required.
- Develop and install comprehensive product-specific and platform critical reagent knowledge management plans and cross-train team.
- 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 Required Education and Experience:
- Bachelor of Science (BS) degree 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 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.
Preferred Experience and Skills:
- Prior experience supporting critical reagent lifecycle activities.
- Prior people management experience or direct experience in leadership role for matrixed project team.
- 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.