(CMO) Project Manager

Job description

The Project Manager is responsible for the successful execution of SBL’s drug substance (DS) programs for large-molecule biologics, from project kickoff through product delivery. The Project Manager is accountable for the overall project lifecycle, spanning engineering and clinical-stage activities through Process Performance Qualification (PPQ) and commercial manufacturing. The Project Manager will integrate input from and collaborate with cross-functional teams, including MSAT, Operations, Quality Assurance, Quality Control, Procurement, Sales, Development, and Finance, to execute program requirements and support successful customer delivery. As the primary client-facing project lead, the Project Manager serves as the main point of contact for project-related matters for both internal and external stakeholders. The role is responsible for escalating critical issues to leadership and executive management and facilitating Joint Steering Committee (JSC) and Executive Steering Committee (ESC) meetings, as appropriate. Senior Project Managers are also expected to mentor and provide guidance to junior and newly appointed project team members. Success in this role requires a strong biopharmaceutical operations background, business acumen, excellent client-management skills, and the ability to lead through influence in a complex, cross-functional environment. The Project Manager will align with Songdo Project Management practices and business objectives, working collaboratively across sites as one company. Strong communication and proactive alignment with Songdo Project Management are essential to provide consistent guidance and messaging to clients. Key Responsibilities Lead project scope, schedule, milestone, and critical-path management throughout the program lifecycle. Manage project financial activities, including sales forecast updates, purchase orders, invoicing, and support for financial reporting. Serve as the primary point of contact for assigned customer programs. Coordinate activities across MSAT, Operations, QA, QC, Procurement, Sales, Development, Finance, and other relevant functions. Collaborate with internal and external senior leadership to resolve escalated or critical project issues in a timely manner and maintain client satisfaction. Facilitate JSC and ESC meetings and ensure appropriate escalation of program risks, issues, and decisions. Drive achievement of program goals and milestones by continuously monitoring project performance against established objectives, schedules, and metrics. Identify, assess, and communicate project risks and work with cross-functional teams to develop and execute appropriate mitigation plans. Execute timely escalation when project scope, schedule, quality, financial performance, or customer commitments are at risk. Maintain a strong client-focused mindset by understanding customer needs and collaborating with cross-functional teams to develop effective solutions. Partner closely with Songdo Project Management to ensure consistency in project-management practices and communications with clients. For senior-level positions, mentor and provide guidance to junior and new project team members. EducationBachelor’s or advanced degree in Biology, Biochemistry, Biological Sciences, Bioengineering, Chemical Engineering, or another related scientific or engineering discipline. Required Experience8+ years of professional experience within global pharmaceutical/biopharmaceutical companies or leading CDMOs. Experience with CMC drug development, biologics manufacturing, and global operations, including milestone and critical-path management. Demonstrated project-management experience in complex, cross-functional environments. Experience managing client relationships and communicating with internal and external stakeholders. Preferred ExperiencePrevious experience in Project Management, Sales, Operations, or other client-facing roles. Experience supporting biologics programs through clinical, PPQ, and/or commercial manufacturing stages. Strong project management, business-process management, and process-optimization skills. Strong negotiation skills balanced with a client-centric approach. Excellent written and verbal communication skills. Business proficiency in English required; Korean working proficiency preferred. Excellent leadership, collaboration, stakeholder-management, and influencing skills. Proficiency with project-management tools, such as Microsoft Project, for managing or forecasting timelines, budgets, and resources. Knowledge of GxP requirements, Quality Systems, and applicable FDA and EMA regulations. Relevant project-management training or certification, such as PMP or equivalent is preferred The anticipated salary range for this position in Maryland is $100,650 to $113,420 plus annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Benefits: · 13 paid holidays · Vacation time · 401K match · Medical, dental and vision benefits effective day one of employment