Senior Staff, Manufacturing Technical Operations

Biopharma-Consulting-Jad-Group; Boston (MA); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Overtime availability

Job summary

The Change Control Project Manager role at Biopharma-Consulting-Jad-Group coordinates cross-functional teams to manage change controls for cell and gene therapy projects in Boston. You will maintain integrated project plans, track milestones, and drive timely decisions in a GMP environment.

You will communicate status to stakeholders, organize team communications, and develop tools to support change control activities while adhering to SOPs and regulatory requirements (FDA, EU GMP, ICH Q10).

Qualifications

• Bachelor’s degree in engineering, life sciences or related field.
• 8+ years in biopharmaceutical industry.
• 6+ years in project management of biopharmaceutical products.
• Knowledge of GMPs, regulatory requirements and drug development lifecycle.
• Ability to manage multiple tasks in a cross-functional environment.
• Proficiency with MS Office and PM tools (Smartsheet, Power BI).
• Strong written and oral communication, facilitation and presentation skills.

Responsibilities

• Partner with functional area leads to maintain and monitor integrated project plans.
• Track milestones and critical path activities to drive changes to completion.
• Communicate status, risks and mitigation plans to stakeholders.
• Organize team communications, agendas, minutes, tasks, and risk analyses.
• Update project status tools and risk registers.
• Develop and deliver PM templates and tools for the change control team.
• Comply with SOPs and applicable GxP requirements.

Skills

Project management

Cross-functional collaboration

Communication

Analytical thinking

Problem solving

Education

Bachelor's degree in engineering or life sciences

Tools

MS Project

PowerPoint

SharePoint

Word

Excel

Outlook

Smartsheet

Power BI

Job description

The Change Control Project Manager is responsible for supporting the cross-functional project teams executing change controls. The Project Manager will track and report project scope/timeline/milestone status associated with cell and gene therapy T1D team.

RESPONSIBILITIES

• Partner closely with functional area leads, maintain and actively monitor integrated project plans. Identify/communicate interdependencies as well as critical path activities for the project(s)
• Track and monitor key milestones and decision points and work with project team members to drive the completion of changes.
• Effectively communicate with internal team members and key stakeholders on the status, objectives, risks, and mitigation plans associated with change control projects.
• Organize and maintain team communications including meeting agendas, minutes, tasks lists, and risk analyses/mitigation strategies.
• Update and maintain project status tools, such as a project action log and risk register.
• Develop and deliver project management tools and templates to manage change control team activities.
• Consistently perform duties within established SOPs, and in accordance with GxP requirements, where applicable

• Bachelor’s degree in engineering, life sciences or related field.
• A minimum of 8 years of experience in the biopharmaceutical industry.
• A minimum of 6 years of experience in project management of biopharmaceutical product
• Working knowledge of biotechnology, GMPs, and drug development lifecycle.
• Ability to work effectively in cross-functional, matrixed environment, prioritizing and managing multiple tasks simultaneously, integrating cross-functional issues and balancing competing priorities effectively.
• Expertise in Microsoft suite (Project, PowerPoint, SharePoint, Word, Excel, Outlook). Experience with other PM tools a plus (e.g., Smartsheet, Power BI, etc.).
• Excellent oral and written communication skills, including presentation and facilitation skills, to effectively inform key updates & issues across all levels of the organization.
• Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective.
• Strong understanding of regulatory requirements (FDA, 21 CFR Part 211, EU GMP, ICH Q10)
• Understanding of risk assessment.

MUST HAVE:

• Proven history in managing and driving project success within the biotech industry.

• Strong technical background, solid working knowledge of GMPs, understanding of the drug development pathway through commercialization, and willingness to pivot as priorities change.
• Knowledge and/or experience with cell / gene therapy methodologies and a strong understanding of risk management will be an asset.

• 1- year contract with possible extension
• Administrative shift
• Overtime availability