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MiMedx · 2 months ago

CMC Project Manager

Marietta, GA

Full-time

Hybrid

Senior Level, Lead/Staff

10+ years exp

Mimedx Group Inc. is dedicated to helping humans heal through regenerative biologics. They are seeking a CMC Project Manager to lead the planning and execution of projects related to tissue product development and medical device integration, ensuring compliance with regulatory standards and quality requirements.

BiotechnologyHealth CareMarketingMedicalMedical DeviceWellness

Comp. & Benefits

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

Qualification

CGMP KnowledgeRegulatory ComplianceProject ManagementStatistical AnalysisRoot Cause AnalysisTechnical WritingMulti-taskingMS Office ProficiencyPMP CertificationCollaborationCommunication SkillsOrganizational SkillsTime ManagementAttention to DetailFlexibility

Required

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

Demonstrated effectiveness in project management disciplines

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