Program Manager II
Maravai LifeSciences
4 hours ago
On-site
San Diego, CA
$84,851 - $96,055 USD yearly
Operations
Program Manager II (CDMO / GMP Services)
Responsibilities:
- Own end-to-end execution of GMP Services programs at TriLink as the single point of contact.
- Interface with Operations, Commercial, Process Development, Quality, Engineering, and other teams to meet customer timelines and deliver milestones.
- Serve as a client’s advocate; actively problem-solve to ensure excellent customer service and on-time delivery.
- Manage and own customer contractual deliverables; lead cross-functional project teams to ensure contractual obligations are met.
- Direct, lead, and motivate multi-disciplinary teams to deliver GMP Services milestones from pre-Clinical through Commercial phases; liaison between customer and internal teams.
- Actively manage 3+ small to medium complexity customer drug development/manufacturing programs.
- Manage contractual obligations and milestones; flag when additional scope requires a new proposal/Change of Scope, or when billing/audit requests arise.
- Facilitate effective internal and customer-facing meetings (agendas, schedules, KPIs, risk/issue management, minutes, action items).
- Maintain accurate project timelines and project management tools; identify/escalate risks and opportunities to keep programs on-track.
- Conduct internal/client meetings to monitor execution against the Statement of Work and resolve open items for milestone delivery.
- Participate in internal operating mechanisms and report out to PgM Leadership on progress, risks/opportunities, customer health, and other metrics as appropriate.
Qualifications:
- Bachelor’s degree in Business, Engineering, Life Sciences, or related field, with 2–4+ years relevant experience in customer-facing project/program management and/or customer-facing technical roles (master’s may require 0–2 years).
- Direct biotechnology/pharmaceutical experience in pre-IND to late-phase clinical drug substance and drug product development.
- Direct experience within a CDMO managing a client’s program portfolio, or relevant experience operating within a CDMO Project Core Team (required).
- Working knowledge of CMC considerations: quality systems, GMP, ICH guidelines, FDA, USP, and related regulatory requirements (required).
- Excellent leadership and interpersonal skills (required).
- Project management experience with direct project management required, or portfolio-level management/participation in project teams; experience using tools such as MS Project, Smartsheet, MS Office, and ERP systems such as NetSuite.
- Ability to build relationships in a matrixed organization.
- Experience with mRNA and plasmids is a plus.
Benefits (as stated):
- RSU grants/employee stock purchase plans; comprehensive medical plans with HSA/FSA options; fertility & family planning assistance; additional optional benefits/insurance (including pet insurance); retirement contributions; holidays & paid time off.
Application instructions:
- Not specified in the provided text.
Responsibilities:
- Own end-to-end execution of GMP Services programs at TriLink as the single point of contact.
- Interface with Operations, Commercial, Process Development, Quality, Engineering, and other teams to meet customer timelines and deliver milestones.
- Serve as a client’s advocate; actively problem-solve to ensure excellent customer service and on-time delivery.
- Manage and own customer contractual deliverables; lead cross-functional project teams to ensure contractual obligations are met.
- Direct, lead, and motivate multi-disciplinary teams to deliver GMP Services milestones from pre-Clinical through Commercial phases; liaison between customer and internal teams.
- Actively manage 3+ small to medium complexity customer drug development/manufacturing programs.
- Manage contractual obligations and milestones; flag when additional scope requires a new proposal/Change of Scope, or when billing/audit requests arise.
- Facilitate effective internal and customer-facing meetings (agendas, schedules, KPIs, risk/issue management, minutes, action items).
- Maintain accurate project timelines and project management tools; identify/escalate risks and opportunities to keep programs on-track.
- Conduct internal/client meetings to monitor execution against the Statement of Work and resolve open items for milestone delivery.
- Participate in internal operating mechanisms and report out to PgM Leadership on progress, risks/opportunities, customer health, and other metrics as appropriate.
Qualifications:
- Bachelor’s degree in Business, Engineering, Life Sciences, or related field, with 2–4+ years relevant experience in customer-facing project/program management and/or customer-facing technical roles (master’s may require 0–2 years).
- Direct biotechnology/pharmaceutical experience in pre-IND to late-phase clinical drug substance and drug product development.
- Direct experience within a CDMO managing a client’s program portfolio, or relevant experience operating within a CDMO Project Core Team (required).
- Working knowledge of CMC considerations: quality systems, GMP, ICH guidelines, FDA, USP, and related regulatory requirements (required).
- Excellent leadership and interpersonal skills (required).
- Project management experience with direct project management required, or portfolio-level management/participation in project teams; experience using tools such as MS Project, Smartsheet, MS Office, and ERP systems such as NetSuite.
- Ability to build relationships in a matrixed organization.
- Experience with mRNA and plasmids is a plus.
Benefits (as stated):
- RSU grants/employee stock purchase plans; comprehensive medical plans with HSA/FSA options; fertility & family planning assistance; additional optional benefits/insurance (including pet insurance); retirement contributions; holidays & paid time off.
Application instructions:
- Not specified in the provided text.