Location: Remote - Thousand Oaks, CA

Employment Type: Contingent Worker (Contract, W2)

Contract Length: 12 months (possible extension)

Compensation: $44/$50 per hour (based on experience)

Summary of the Role

Join a big biopharma leader's Contract Development and Manufacturing team to support outsourced synthetic-related activities for clinical and commercial drug substance supply. Play a critical cross-functional role driving external development, sourcing, and oversight for synthetic small molecule drug products. Support all stages from supplier onboarding to continuous improvement, ensuring project deliverables and compliance with cGMP.

Key Responsibilities

• Oversee and support activities at external synthetic/process chemistry sites for deliverables, compliance, timelines, quality, and cost
• Collaborate with ACDM, Process Development, External Quality, Supply Chain, and internal stakeholders in sourcing and scope management
• Coordinate material and sample shipments between external sites
• Manage purchase orders, invoices, and project budgets
• Oversee deviation investigations and handle change management as necessary
• Maintain and update business trackers for operational oversight
• Support and drive continuous improvement initiatives within ACDM
• Ensure execution according to cGMP and ACDM business practices
• Perform other related duties as required

Required Experience & Skills

• 4+ years of manufacturing or operations experience in a relevant industry
• Background in Engineering, Chemistry, or other science-related field
• Familiarity with project management processes
• Knowledge of cGMP and regulatory/CMC requirements in pharmaceuticals
• Strong cross-functional collaboration and communication skills

Preferred Qualifications

• In-depth knowledge of synthetic drug development and manufacturing processes
• Experience interfacing with and managing CRO and CDMO relationships
• Expertise in change management, deviation investigations, and CAPA implementation
• Direct experience with tech transfer and commercialization of synthetic therapeutics
• Prior experience working as part of a matrix or cross-functional team

Top 3 Must Have Skills

1. Chemistry-related industry or environment experience

2. Knowledge of synthetic drug development and manufacture

3. Experience in project management

Day-to-Day Responsibilities

• Provide oversight and support for external process chemistry projects including compliance, timelines, product quality, and cost at selected and subcontracted sites
• Work closely with other teams in the business to handle sourcing, manage documentation, and coordinate shipments
• Administer purchase orders, budget, deviation investigations, and business trackers
• Drive ongoing process improvements and operational excellence efforts

Basic Qualifications

• Bachelor degree
• Associate degree and 4 years of experience
• High school diploma / GED and 6 years of experience

This posting is for Contingent Worker, not an FTE