Serving as the CSC project and team leader for assigned compounds.
Driving global teams to define and manage change, challenge the status quo, and implement solutions.
Providing mentorship and guidance to team members.
Leading the monthly Clinical Supply & Operations Planning (cS&OP) cycle for each compound.
Developing and maintaining an integrated demand and supply plan from API to clinical kits.
Handling partner concerns and resolution of critical risks and issues with minimal supervision.
Representing CSC on Chemistry, Manufacturing and Controls (CMC) and Clinical teams (CT), ensuring alignment with product strategy.
Communicating and implementing strategy and development plans with high autonomy and accountability.
Building strong collaborations with Therapeutic Areas (TAs), Global Development (GD), and Therapeutics Development & Supply (TDS).
Acting as Single Point of Contact (SPOC) for TAs and GD as needed, supporting due diligence, partnerships, and early access programs.
Ensuring uninterrupted clinical supply through effective planning, budgeting, and coordination.
Influencing trial design and operational aspects to optimize cost efficiency and customer experience.
Managing compound activities to meet key CSC/CMC/CT deliverables, including long-range demand forecasting, formulation selection, and comparator sourcing.
Participating in Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) health authority inspections.
Contributing to functional strategy development and process improvements (quality, cost, time, asset utilization).

Requirements

A minimum of a Bachelor's degree is required.
8+ years of relevant experience is required.
Strong knowledge of GCP/GMP regulations and clinical trial operations is required.
Ability to manage complex projects with accelerated timelines is required.
Problem Solving/Decision Making - Creates a culture that empowers others in the analysis of strategic issues; independently identifies and manages the impact across the business with no supervision required.
Project Management - Leads multi-dimensional projects across the business; manages the inter-relationships among projects to drive optimal outcomes, processes, and people.
CMC Drug Product Development - Demonstrates in-depth knowledge of end-to-end (E2E) CSC activities and the broader development process/organization to support the G&O development with impact on departmental strategy.
E2E CSC Accountability - Accountable for portfolio projects across CMC and clinical teams'; manages internal and external partners; understands and helps shape strategic objectives and translates them into day-to-day execution.
Matrix Team Leadership – Leads the CSC sub- team applying innovative approaches and out of the box thinking; provides coaching to help develop the team members.
Quality – Ensures project activities which is safe, effective and otherwise aligned with global health authority expectations.
Communication - Develops forums, systems, and processes that result in information sharing internally and externally; confidently presents controversial and/or complex information to all levels of the organization.
Critical Thinking - Understands and shapes strategic objectives of the TDS organization and implements these strategies in daily activities;; helps others understand and apply organizational objectives.
Cross-Functional Coordination - Viewed as a trusted partner across the business and with internal/external therapeutic area experts; anticipates relationship needs, proactively builds alliances, and leverages partnerships strategically.

Benefits

medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
consolidated retirement plan (pension)
savings plan (401(k))
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

GCPGMPproject managementclinical trial operationsdemand forecastingformulation selectioncomparator sourcingchange managementsupply chain planningdrug product development

Soft Skills

problem solvingdecision makingmatrix team leadershipcommunicationcritical thinkingcross-functional coordinationmentorshipcollaborationinfluencingautonomy

Certifications

Bachelor's degree