Provide Quality Assurance oversight for GMP manufacturing, release, and stability activities for veterinary pharmaceutical products. Manage batch disposition and quality events while collaborating with CDMOs and regulatory affairs to ensure compliance with cGMP and VICH guidelines.
Loyal
8 Remote Job Openings at Loyal
Lead the analytical development and quality control strategy for oral solid dosage programs, overseeing method lifecycle management and regulatory submissions. Act as the primary technical point of contact for CDMOs and serve as the final scientific authority for OOS and atypical result investigations.
Provide strategic leadership for analytical development and commercial quality control across the product pipeline. Oversee the full QC lifecycle from early development through commercialization, ensuring regulatory compliance and managing external GMP partners.
The role is responsible for building and maintaining the company's Quality Management System (QMS) and overseeing GxP Computer System Validation (CSV) requirements. It involves managing SOPs, training programs, and ensuring regulatory readiness for FDA-CVM drug submissions.
Lead end-to-end drug substance process development and manufacturing for small molecule APIs from early development through commercialization. Serve as the primary technical interface with CDMO partners and author CMC sections for regulatory submissions.
The COO will own the operational execution of the company's first commercial launch in 2027, managing Finance, People, Engineering, and Commercial functions. They are responsible for scaling the organization from 70 to 150 people using AI-leveraged efficiency and managing the internal operating cadence.
Lead the design, execution, and strategic direction of clinical programs for veterinary longevity drugs. Drive end-to-end clinical strategy from target product profiles to regulatory-facing protocol development and evidence package generation.
The Director will serve as the subject matter expert for FDA CVM regulatory strategy, leading clinical trial operations and agency interactions. They will oversee regulatory submissions, provide guidance on clinical studies, and manage a team to ensure compliance and strategic alignment.
