Primary RoleWe are seeking an experienced Director/Senior Manager, CMC Quality to provide quality oversight for Chemistry, Manufacturing, and Controls (CMC) and Clinical Supplies activities across Alto's drug substances, drug products, and packaged products, ensuring GMP compliance and inspection readiness as programs move toward registrational and eventually commercial manufacturing. Level will flex based on candidate experience.
What you'll doQuality Oversight- Manages the QA oversight of GMP manufacturing vendors, including involvement and review of method validation documentation, stability protocols and reports, GMP drug substance and drug product specifications, GMP drug substance and drug product master/executed batch records, and GMP drug substance and drug product release.
- Manages the QA oversight of GMP Clinical Supply vendors, including master/executed batch record reviews, and Clinical Supply release.
- Attend vendor meetings with the applicable functional areas and ability to provide quality feedback.
- Provide quality input to CMC Operations for vendor initiated change controls, deviations, and CAPA processes.
- Lead or support GMP audits of manufacturing and testing partners, as well as Clinical Supply/Depot vendors.
- Prepares GMP metric reports and trending analysis for VP of Quality for periodic Management Reviews.
- Maintain ALTO Controlled Documents specific to CMC Quality activities.
- Performs other duties as assigned.
Cross-Functional CMC Support- Partner closely with CMC Operations, Clinical Supplies, Regulatory Affairs, Clinical Operations, and other members of the Quality organization to support compliant program execution.
- Partner with CMC Operations and Clinical Supplies on batch record review, specification setting, stability program oversight, and vendor management.
Systems Build- Provide insight into quality systems and documentation practices appropriately scaled for a company transitioning from clinical-stage to commercial-readiness manufacturing.
LocationPreferred: Mountain View, CA (hybrid). Remote considered for the right candidate.
Salary Range$165-180k (Senior Manager), $215-240k (Director)
*depending on qualifications and experience levelTravel RequiredPeriodic travel to the CDMO/Clinical Packaging sites and home office for company-wide meetings.
QualificationsRequired Skills/Abilities: Required (Director level)- 10+ years of CMC quality experience in biotech/pharma, including direct CMO/CDMO oversight
- Experience supporting late-stage (Phase 3) or commercial-track CMC quality programs
- Strong working knowledge of FDA GMP requirements and change control/deviation/CAPA systems
- Experienced in conducting GMP and Clinical Supply vendor site audits
Required (Senior Manager level) - 6-9 years of CMC quality experience with meaningful CMO oversight exposure
Bonus Skills/Abilities: - Experience with oral solid dose CNS products specifically
- Knowledge with various packaging designs
- Experience preparing for or supporting a pre-approval inspection (PAI)
Supervisory Responsibilities:Education and Experience:- B.S in a scientific discipline (e.g. chemistry, biochemistry, biology, life sciences)
