The Director - Manufacturing at ECM Therapeutics provides manufacturing and laboratory activities oversight, participates in and schedules daily activities associated with manufacturing ECMT products which meet company Quality System standards, standard operating procedures, and regulatory requirements.
Key Responsibilities and Duties:
Provide direct guidance to employees to ensure products and operations meet the company Quality System, cGMPs, and safety standards
Delegate work to employees, track progress and provide constructive feedback throughout projects and tasks
Organize workflow and ensure that employees understand their duties or delegated tasks
Act as functional point person for troubleshooting, coordination with other functional groups, and providing decision points for product and operational concerns
Responsible for laboratory and manufacturing inventory levels, record keeping and planning ahead for manufacturing / laboratory needs
Manufacturing Activities:
Schedule resources to ensure that all daily tasks are completed, actively participate in manufacturing (secondary verification), filling in additional manufacturing responsibility gaps as necessary
Track, improve, and optimize manufacturing processes
Laboratory Activities:
Responsible for lab organization and workflow, troubleshooting equipment
Actively participating in benchtop experiments as necessary (e.g., release testing, stability testing, raw material verification)
Development of new research protocols and writing SOPs
Additional Responsibilities:
Initiate, author, and perform departmental review of quality system records and documentation (i.e. investigations, batch records)
Obtain and maintain required internal company qualifications, including but not limited to: gowning qualification, aseptic qualification
Follow proper cleanroom behavior and aseptic practices while working inside the manufacturing suite and cleanroom environments