Natick, MA | Full-time
The Director of Operations will oversee Company operational activities and provide strategic leadership to maximizing the manufacturing process efficiency and to project and meet financial and schedule goals. This role will report directly to the COO and will provide day-to-day leadership and management to the Operations organization that mirrors the values and mission of Pillar and will provide critical insights to the strategy of the company.
Duties and responsibilities
- Implement high level standard operating procedures and policies to ensure day-to-day compliance with regulatory requirements (e.g. ISO13485 standards, environmental health & safety).
- Work with Senior Management to establish company operational objectives and meet operational requirements
- Supervise the activities of the operations team as it grows and direct purchasing, receiving, and inventory monitoring related to manufacturing.
- Establish procedures to maintain equipment performance, develop equipment standard operating procedures for IQ/OQ/PQ, troubleshoot routine equipment issues, and manage company Calibration and PM
- Supervise/Manage laboratory waste removal and proper storage of
- Work with QA and QC to manage relationship with OEM product suppliers and approve
- BS or MS in a scientific discipline, MBA a plus for working with developing teams.
- Operational experience in the manufacture of nucleic-acid based Molecular Diagnostics (RUO/IVD) and/or Companion Diagnostics.
Knowledge, Skills, and Abilities:
- Experience in managing operations in biotechnology startups and/or emerging companies.
- Preference for candidates with hands-on experience working with SAP.
- Strong organizational and multi-tasking skills to work in a dynamic environment with evolving priorities.
- Excellent analytical, organizational, communication, documentation, and negotiation skills. A strong, collaborative team player.
This position is conducted in a standard office environment. The role routinely requires the use of typical office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Must be able to sit at a computer for long periods of time.
COO Direct Reports: