Senior Staff, Manufacturing Technical Operations

BioPharma Consulting JAD Group; Boston; On-site; PHP 6,897,000 - 10,031,000; Full time

Job summary

BioPharma Consulting JAD Group seeks a Change Control Project Manager to support cross-functional teams in executing change controls for cell and gene therapy programs. You will track scope, timelines, milestones, and communicate risks to stakeholders across the project lifecycle.

The role requires a strong biotech background, deep GMP/regulatory knowledge (FDA/ICH), and excellent cross-functional collaboration skills to drive timely decisions and changes.

Qualifications

• Bachelor’s degree in engineering, life sciences or related field.
• 8+ years in biopharmaceutical industry.
• 6+ years in project management of biopharmaceutical products.
• Working knowledge of biotechnology, GMPs, and drug development lifecycle.
• Strong cross-functional collaboration and communication skills.

Responsibilities

• Partner with functional area leads and monitor integrated project plans.
• Track milestones, decisions, and drive change completion.
• Communicate status, risks, and mitigation plans to stakeholders.
• Organize team communications: agendas, minutes, tasks, risk analyses.
• Update project status tools and risk registers.
• Develop templates to manage change control activities.
• Perform duties in line with SOPs and GxP requirements.

Skills

PM leadership

GxP knowledge

FDA/ICH regs

MS Office suite

Power BI

Risk management

Cross-functional

Biotech experience

Education

Bachelor’s degree

Tools

Smartsheet

Power BI

Microsoft Project

SharePoint

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