CMC Project Manager

At MIMEDX, our purpose starts with helping humans heal. We are driven by discovering and developing regenerative biologics utilizing human placental tissue to provide breakthrough therapies addressing the unmet medical needs for patients across multiple areas of healthcare. Possessing a strong portfolio of industry leading advanced wound care & surgical products, we are committed to making a transformative impact on the lives of patients we serve globally. Will you join us on this journey?

We are excited to add CMC Project Manager to our Technology Transfer team! This role will be a hybrid. The position will pay between $93,000 - 133,000k annually based on previous relevant experience and educational credentials.

POSITION SUMMARY:

MIMEDX is looking for a highly motivated and self-driven leader to join our dynamic and diverse Technology Transfer team of engineers and scientists. MIMEDX has a rapidly growing portfolio of healthcare products. To support this growth, the company is expanding the technology transfer team with talented individuals who will help develop and transition these products through the manufacturing and regulatory pipelines to patients. The successful candidate for this position will make an immediate impact on the development of our tissue product and medical device pipelines by integrating with the project team and planning and tracking projects to progress late-stage development and transfer activities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Effectively manage the planning, development, and execution of projects supporting tissue products process development and medical device integration programs.
• Collaborate with cross-functional teams to execute projects for biologic specific manufacturing processes, product characterization, and product testing.
• Ensure that Protocols, methods, and procedures are reviewed and executed per regulatory requirements and business needs.

• Track project timeline elements to ensure that functional deliverables are completed on time and according to relevant quality standards.

• Plan and execute characterization studies during development for commercial supply chain(s) including review and approval of release testing plans. Review quality control plans and provide certification that design requirements meet specifications and are in compliance with cGMPs
• Perform technical analysis of project data, including trending of data, root cause analysis, and predictive statistics.
• Actively contribute to writing key tissue product and medical device development sections of regulatory documents and responses to regulatory authorities
• Promote a culture of collaboration, cooperation, execution excellence, effective communication, and cross-functional problem-solving to enable a high-performing team.
• Maintain productive and professional relationships with partners, collaborators, departments, contractors and customers.
• Author/review technical protocols, reports and deliver presentations utilizing sound scientific reasoning and interpretation of the available data

PROBLEM SOLVING:

• Solutions require analysis and investigation
• Knowledge around the various root cause determination techniques
• Able to understand and implement statistical trending processes
• Assesses issues thoroughly and solves complex problems quickly; removes roadblocks for the team
• Able to define and communicate issue escalations to leadership per defined timing.

DECISION MAKING/SCOPE OF AUTHORITY:

• Achieves planned results by decisions and actions based on professional methods, business principles, and practical experience
• May recommend/make decisions regarding existing or new programs/initiatives that have a significant medium to long-term impact to business operations/outcomes and carry potential consequences if unsuccessful

SPAN OF CONTROL/COMPLEXITY:

• Responsible for execution strategy and vison typically with a short-term operational focus on business results (e.g. 1 year)
• Manage staff/administrative departments/areas
• Manage business operations or technical departments/areas
• Manage business functions/process

EDUCATION/EXPERIENCE:

• Bachelor's Degree in a related science/medical research field and minimum of ten (10) years of relevant work experience within a regulated field; or an appropriate combination of relevant education and experience.
• Minimum of five (5) years of training or experience in the category or categories of tissue, medical device, or pharmaceutical manufacturing.
• Must have a strong working knowledge of good documentation practices, cGMPs, design processes, and process development; monitoring and statistical analysis.
• Must have strong knowledge of CAPA and root cause analysis.
• Knowledge of the following: FDA, AATB, ISO, and other state/federal regulations and standards.

SKILLS/COMPETENCIES:

• Demonstrated effectiveness in project management disciplines (PMP certification preferred)
• Demonstrated aptitude and proficiency in MS Word, MS Excel, MS project, Minitab, and Windows-based operating systems
• Must be able to communicate ideas and information clearly, effectively, and frequently (oral and written) within a team, the company, and with outside consultants.
• Must have strong technical writing skills and strong organization skills with attention to detail.

• Ability to prioritize and respond with a sense of urgency to all inquiries and requests
• Ability to manage time and workload effectively; organized, flexible, and able to multi-task while maintaining a high level of efficiency and attention to detail

WORK ENVIRONMENT/EXPECTED BUSINESS TRAVEL:

The work is typically performed in a normal office environment. Role routinely uses standard office equipment. Additional work will occur in laboratory and controlled environment areas.

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to, or requirements for, this job at any time.