Manager, CMC Operations Program Management

ElevateBio; Waltham (MA); Hybrid; USD 125,000 - 165,000; Full time

Job summary

ElevateBio in Waltham, MA is seeking a Manager, CMC Operations and Program Management to lead cross-functional activities across CMC, process development, analytical development, facilities and engineering, MSAT, manufacturing and supply chain within BaseCamp. The role supports internal portfolios and aligns program milestones with corporate goals in a GMP setting.

The position is hybrid with 2-3 days onsite a week, offering a salary range of $125,000 to $165,000 and opportunities to influence

Qualifications

• MS in a scientific or engineering discipline.
• 3+ years of relevant experience in the CMC environment; cell/gene therapy preferred.
• cGMP program management experience is required.
• Strong understanding of US FDA and EU EMA regulations and ICH guidelines for cell and gene therapy products is preferred.
• Extensive experience leading product/process programs within a GMP setting.
• Program management skills including budgeting, metrics, and cross-functional coordination.
• Strong verbal and written skills; interpersonal, technical, and troubleshooting abilities.
• Excellent planning, organization, and multitasking skills.

Responsibilities

• Lead cross-functional activities between CMC groups and BaseCamp departments.
• Develop, maintain and track CMC project plans with milestones and budgets.
• Facilitate internal and partner meetings to drive cross-functional communication.
• Identify risks and bottlenecks; implement mitigation plans.
• Generate dashboards on milestones, updates and risks.
• Support Joint Leadership Meetings and standardization of processes.

Skills

Strong verbal and written skills

Interpersonal skills

Troubleshooting abilities

Planning and multitasking

Education

MS in a scientific or engineering discipline

Job description

Manager, CMC Operations Program Management

Waltham, MA - Smith

Department: Commercial Operations & Program Management

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.

The Role:

The Manager, CMC Operations and Program Management will lead the cross-functional activities between CMC groups and other departments at ElevateBio BaseCamp including process development, analytical development, facilities and engineering, MSAT, manufacturing and supply chain within the scope of various programs. The Manager will be a part of the BaseCamp CMC and Program Management department and will aid in supporting both internal portfolios at BaseCamp. This position will contribute to ensuring alignment with corporate goals and timelines. The position is hybrid with 2-3 days onsite a week.

Here’s What You’ll Do:

• Build and maintain strong internal relationships with SMEs at Base Camp (PD, MSAT, Manufacturing, AD/QC, QA, Regulatory, Commercial) and external relationships with scientific and program management staff at partner organization to ensure program goals and accountabilities
• Develop, maintain and track CMC project plans (e.g., detailed Gantt, budget, resources, etc.) with SMEs to encompass key program milestones and deliverables in alignment with overall program objectives with experience/familiarity in the following:
• Autologous / allogeneic cell therapy tech transfers
• Facilitate internal CMC team meetings and meetings with BaseCamp partners using meeting management best practices (both what and how) to drive cross-functional communication, timely and effective decision-making, and successful execution of program activities
• Proactively identify risks, gaps, and resource bottlenecks, and work with impacted teams to develop and implement mitigation plans
• Generate dashboards indicating key program milestones, updates, risks and challenges
• Maintain risk registers, decision logs, and change requests
• Help prepare content for Joint Leadership Meetings
• Support the standardization of processes and communication(s) in order to build efficiencies within the department
• Contribute to the management and review of KPIs at BaseCamp
• Hold weekly 1:1s with BaseCamp partner counterparts to ensure program milestones are being met
• Work closely with finance and department leads for invoicing

Requirements:

• S. in a scientific or engineering discipline
• 3 or more years of relevant experience in the CMC environment. Cell/gene therapy preferred.
• cGMP program management experience is required
• Strong understanding of US FDA and EU EMA regulations and ICH guidelines for cell and gene therapy products is preferred
• Extensive experience is leading product/process program within a GMP setting
• Program management skills, including strategic and tactical programs/tasks, tracking and adhering to budgets, reporting program and campaign metrics, and other program management tools
• Strong verbal and written skills are required as well as effective interpersonal, technical, and troubleshooting skills
• Outstanding planning, organization, and multitasking skills

The budgeted range for this position is $125,000 - $165,000. This range is a good faith estimate of the expected salaryrange for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.