The Role
Leads technical and commercial execution of sterile BFS pharmaceutical programs from feasibility and technology transfer through validation, launch, and commercial supply. Serves as the primary client contact, directs cross-functional teams, manages schedules, risks, scope, change orders, regulatory deliverables, budgets, and audits. Mentors project managers, supports PMO governance, and improves project standards, dashboards, and stage-gate processes. The role is on-site in Columbia, South Carolina, with access to manufacturing and laboratory areas.
Summary Generated by Built In
The Senior Project Manager leads the technical and commercial execution of multiple client programs for sterile, unit-dose products manufactured by Blow-Fill-Seal (BFS) aseptic processing — from feasibility and technology transfer through registration batches, process validation, launch, and ongoing commercial supply. This customer- facing role is the primary point of contact for assigned clients and directs cross-functional teams across the site. It is the senior individual-contributor role within the Project Management Office and is positioned as a development role for progression into Project Management leadership: the incumbent is expected to mentor project managers, act as designee for the Director of Project Management, and take an increasing share of portfolio-level and PMO governance responsibility.
Key Responsibilities:- Lead assigned client programs end to end for sterile BFS products — feasibility, quotation support, technology transfer, engineering and registration/exhibit batches, process validation (PPQ), stability, launch, and commercial supply.
- Serve as the primary customer contact and own the relationship at both working and executive level, including project review meetings, business reviews, and joint steering committees.
- Develop and maintain integrated project schedules, critical-path and resource analyses, risk registers, and milestone tracking tools. Report any variance as soon as it is recognized, together with a recovery plan.
- Direct cross-functional teams — Product Development, Analytical Services, Quality, Operations, Engineering, Supply Chain, Regulatory Affairs, and Finance — without direct reporting authority.
- Own project scope and change control: identify out-of-scope work, develop and negotiate change orders, and support quoting, revenue forecasting, and cash-flow phasing with Finance.
- Coordinate regulatory deliverables with Regulatory Affairs in support of ANDA, NDA/505(b)(2), and post-approval submissions, including customer data packages and response timelines.
- Represent Project Management in customer audits, technical visits, and regulatory inspections; coordinate cross-functional responses to customer technical queries and audit observations.
- Mentor and provide day-to-day direction to Project Managers, Associate Project Managers, and Project Coordinators, including review of their project plans and customer-facing deliverables.
- Serve as designee for the Director of Project Management as assigned, including portfolio reporting to site leadership and representation in leadership and governance meetings.
- Advance PMO capability — stage-gate standards, templates, project KPIs and dashboards, and lessons- learned reviews at program close.
- Establish and maintain internal and external meeting agendas and minutes as the controlled record of project decisions.
Qualifications:
Required Skills & Competencies:- Bachelor’s degree in Life Sciences, Chemistry, Engineering, Pharmacy, or a related field.
- Minimum 5-7 years of pharmaceutical, biotech, or CDMO experience, including at least 3 years directly managing projects.
- Sterile/aseptic manufacturing experience is preferred. Blow-Fill-Seal, sterile injectable, ophthalmic, or inhalation unit-dose experience is strongly preferred.
- Demonstrated ownership of at least one product through technology transfer and process validation into commercial supply.
- Direct external customer-facing experience in a contract development and manufacturing environment.
- Working knowledge of cGMP (21 CFR 210/211), FDA, EMA, ICH, and EU GMP Annex 1 requirements.
- PMP certification preferred; Lean Six Sigma a plus.
- Experience mentoring or leading project managers, or demonstrated readiness to progress into a people- leadership role.
- Strong customer relationship management, including the ability to hold a defensible technical positionwith a client while protecting the relationship.
- Excellent written and verbal communication; able to present credibly to both customer and Ritedose executive leadership.
- Financial fluency — project budgets, change orders, capital versus expense, and the revenue impact ofschedule movement.
- Technical judgment in aseptic processing, validation, and analytical/stability requirements sufficient to challenge and defend proposed timelines.
- Proficiency with project scheduling tools (MS Project, Smartsheet, or equivalent) and with electronic QMSand ERP systems.
- Leadership presence and the ability to influence without authority across a matrixed organization.
- Discretion in handling confidential customer information and competing client interests.
- On-site position in Columbia, SC, with regular presence required in manufacturing and laboratory areas.
- Must be able to gown for and enter classified/controlled areas and comply with GMP dress code and site EHS requirements.
Skills Required
- Bachelor's degree in Life Sciences, Chemistry, Engineering, Pharmacy, or a related field
- Minimum 5–7 years of pharmaceutical, biotech, or CDMO experience
- At least 3 years of direct project management experience
- Sterile or aseptic manufacturing experience
- Blow-Fill-Seal, sterile injectable, ophthalmic, or inhalation unit-dose experience
- Ownership of at least one product through technology transfer and process validation into commercial supply
- External customer-facing experience in a contract development and manufacturing environment
- Working knowledge of cGMP, 21 CFR 210/211, FDA, EMA, ICH, and EU GMP Annex 1 requirements
- PMP certification
- Lean Six Sigma experience
- Experience mentoring or leading project managers, or readiness to progress into people leadership
- Strong customer relationship management and ability to defend technical positions while protecting client relationships
- Excellent written and verbal communication and executive presentation skills
- Financial fluency in project budgets, change orders, capital versus expense, and revenue impacts
- Technical judgment in aseptic processing, validation, analytical, and stability requirements
- Proficiency with MS Project, Smartsheet, or equivalent project scheduling tools
- Experience with electronic QMS and ERP systems
- Ability to influence without authority across a matrixed organization
- Ability to handle confidential customer information and competing client interests discreetly
- Ability to work on-site in Columbia, South Carolina
- Ability to gown and enter classified or controlled areas and comply with GMP and EHS requirements
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
The Ritedose Corporation is a leading pharmaceutical contract development and manufacturing organization (CDMO) specializing in sterile Blow-Fill-Seal (BFS) technology for branded and generic medications.
