Job Description

A robust analytical testing network is essential to realize our company's mission and strategic priorities to deliver life-changing products through pipeline acceleration and uninterrupted supply of commercial products. The Associate Director, Large Molecule (LM) Critical Reagents (CR) Operations, is a leadership role accountable for compliant formulation/filling, labeling, storage, and distribution activities across internal and external facilities to realize uninterrupted customer supply of well-performing, qualified reagents and select analytical materials for our company's growing inline large molecule product portfolio.

The LM CR Operations, Associate Director will lead a team responsible for the execution of material make, store, and ship activities in accordance with quality system requirements and dates established within cross-functional integrated work plans. Materials within scope of this role include critical reagent source materials, intermediates, and finished reagent forms as well as certain defined analytical materials or samples that require formal control or execution coordination through Large Molecule Analytical Sciences (LMAS). This role will have oversight of associated equipment/facility areas at the West Point and North Wales campuses and is responsible for maintenance of those areas in accordance with GMP/GLP requirements and operational best practices.

Key responsibilities include team management, prioritization support through standardized tier processes, and utilization of metric monitoring to build and sustain a high performing team culture. Key operational expectations include sustainment of real-time inventory accuracy and data integrity within and across LM CR Operations activities and nodes. This role will coach the team to proactively identify and implement near term opportunities to standardize operations, maximize customer service levels, and improve operational efficiency while utilizing current systems and facility capabilities. Additionally, this role will prepare the team for future ways of working aligned with in-flight capital investments to deliver a modernized LM CR Operational facility. As leader of the Operations team, the LM Critical Reagents Operations Lead will routinely collaborate with leaders across LM CR to deliver shared priorities to reduce critical reagent supply risk for established and launching products.

The ideal candidate for this position will have a strong working knowledge of material distribution compliance requirements and operational practices at the WP and NW sites. Familiarity with GMP area operations and maintenance of GMP equipment/facilities in accordance with QMS requirements is required.

This is a new role to integrate previously separate local teams at NW and WP into a single operating unit with harmonized practices, therefore strong communication and collaboration skills are required for engagement within team and with partners/stakeholders across the organization.

Primary activities include, but are not limited to:

As the LMCR Operations team lead, this role is accountable for the compliant and timely execution of activities supporting the preparation, storage, distribution, and logistics of LM CR qualified and controlled materials:

• Ensure execution of reagent formulation/aliquoting batches and material transfers according to target dates according to 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)

• Participate and execute internal and cross functional strategic planning activities, Project planning activities, project prioritization activates

• Ensure accurate and timely execution of work by teams under appropriate GMP and QMS conditions in accordance with appropriate guidance documents.

• Ensures compliance and safety within the organization.

• Establish and monitor KPIs for department performance both internal and external.

• Develop and standardize best practice approach for business and operations supporting material storage, movement, and inventory system transactions and implement at WP and NW sites

• Coach and develop team members to realize full leadership potential

• Ensure employees are competent and qualified to perform duties.

• Develop and maintain standardized communication paths (appropriate Tier Systems)

• Rapidly escalate and resolve issues through tier process.

• Encourage team culture of transparency, support, and accountability.

• Establish a high performing team culture with cross-trained staff for optimal operation and knowledge management

• Forecast and maintain department budget and headcount allocations

• Participate in hoshin and MPS processes to establish principles and prioritized actions to continuously improve departmental activity's reliability of BCR supply, and/or business process efficiency.

• Foster collaboration and strong network connections across LMAS, QC, external storage partners, and other process/analytical partners and customers.

• 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.

• Sponsor investigations, quality initiatives and implementation of new procedures within the organization.

• Provide insight and guidance to new facility capital project through conceptual development, startup activities, facility and equipment readiness, and process and procedure development and standardization.

Minimum Education and Experience Required:

• Bachelor's 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 in pharmaceutical industry with combined experience in an analytical support function (including development and commercialization), Production environments, 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

• Extensive experience in new facility construction and start up

Preferred Experience and Skills:

• Prior experience supporting critical reagent lifecycle activities, including reagent storage and distribution operational or shipping compliance activities

• Prior experience with new facility start-up activities

• Experience in an accountable role for facility maintenance/leadership

• 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.

• 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.

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:

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

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:R315746