What are the responsibilities and job description for the GMP Project Manager (Tech Transfer/Capital Projects) position at a Medical Devices Technology company located in MA?
Project Manager, Technical Operations (Contract)
RESPONSIBILITIES
Demonstrate strong project management skills, including developing and managing schedules, budgets, risk identification and management, and change management.
Collaborate with internal and external cross-functional teams, such as Engineering, Facilities, Manufacturing, Quality, Regulatory, Supply Chain, and other relevant stakeholders, to define project requirements and ensure alignment.
Exhibit project leadership and make effective decisions throughout each project.
Foster effective teamwork by engaging with EH&S, Facilities, Engineering, Quality, Regulatory, Production, area owners, and other key stakeholders.
Establish and maintain effective communication channels with stakeholders, providing regular updates on project status, risks, and mitigation plans.
Monitor project progress, identify deviations from plans, and implement corrective actions as necessary to ensure on-time and on-budget project delivery.
Interface between budget and reporting tools to support management tracking, reporting, and stage-gate decision-making.
Utilize techniques and methods to present data in a format that promotes effective and evidence-based managerial decision-making.
Participate in regular meetings with the management team to provide updates on project progress, risks, mitigation plans, and decisions.
Collaborate with subject matter experts to develop and implement recovery plans and interventions for off-schedule and unanticipated issues impacting project progress.
Perform other duties and projects as assigned.
QUALIFICATIONS
Minimum of 10 years of project management experience within project-based Life Science or Medical Device / Pharmaceutical companies.
Minimum of 8 years of experience managing capital projects, capable of leading multi-disciplined project teams comprising employees, contractors, and consultants.
Strong project management skills with proven experience in managing medium to large capital projects, particularly those emphasizing cGMP cleanroom manufacturing facilities.
Passionate about the work, detail-oriented, analytical, with excellent problem-solving abilities.
Comfortable working in a fast-paced environment; able to adapt to change quickly and positively, and effectively handle various people and situations.
Excellent verbal and written communication skills.
Strong analytical, organizational, and decision-making skills.
Ability to learn rapidly, attention to detail, excellent computer and writing skills, and high levels of energy and self-motivation.
Capable of working on highly complex problems requiring analysis and rational judgment, leading to specific recommendations.
A team player with experience in working with multiple cross-functional teams and leading discussions.
Excellent listening skills, able to interpret input from diverse subject matter experts, clarify needs, and synthesize comprehensive perspectives.
Willingness to support 100% onsite work throughout various project phases.
Strong understanding of Tech Transfer, Commissioning, Qualification, and Validation processes within the medical device and pharmaceutical environment is a plus.
Strong budget / financial management skills relating to CapEx and OpEx spending and project cash flow forecasting is a plus.
Experience in end-to-end project delivery in a cGMP environment (initiation, planning, design, construction, validation, and closeout process) is a plus.
Detailed knowledge of MS Office, Microsoft Project, Microsoft Teams, or other project management software tools is a plus.
Self-motivated team leader with experience in all phases of Planning, Engineering, Manufacturing, and Quality is a plus.
EDUCATION
Bachelor's degree in Engineering, Life Science, Business, or equivalent experience.
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