Summary of Primary Responsibilities:

This position is responsible for leading the Facilities department in accordance with current Good Manufacturing Practices (cGMP), ISO requirements, and industry best practices. Reporting to the Director of Engineering, this position provides the results-oriented leadership and creativity required to build a world-class organization and establish robust and efficient systems. The Facilities group is responsible for the Maintenance and Calibration of all physical assets including process equipment, utilities, and site infrastructure as well as managing Capital Projects. As the company's head of Facilities, the incumbent will manage a multi-million-dollar budget and engage in proactive relationships with local, state, and federal authorities.

Responsibilities:

Provide daily leadership and direction to Facilities team ensuring highest levels of equipment and utility uptime and maintenance of company infrastructure.
Develop, maintain, and continuously improve the preventative maintenance and calibration management programs in compliance with regulatory requirements and industry best practices.
Identify and negotiate with outside contractors to perform specialized repairs and maintenance, maintaining strong relationships with all essential vendors.
Develop, implement and monitor budgets; report potential budget issues and take corrective action to stay within budgets.
Design and plan facility upgrades; acts as Project Lead and coordinates all parties to meet construction deadlines and budgetary requirements.
Develop and maintain relationship with building landlord; resolve issues and concerns between the parties.
Demonstrate excellence in care for not only cGMP aspects of the site, but also ensuring that snow removal, landscaping, salting, office appearance, and general facilities are both presentable and maintained to provide a safe working environment.
Develop and maintain solid working relationships with federal, state and local authorities; represents and advocates Anika's positions with these agencies.
In collaboration with Engineering, support the Facilities team with technical and engineering expertise and solutions to provide a high level of service to Production.
Ensure timely completion of assigned CAPAs, Safety CAPAs, NCs, PDs, Change Controls, etc. and any other quality or exception management workflows.
Provide strategy and leadership with regard to CMMS System (BMRAM) administration, including New Assets, PMs, CALs, GWRs, spare parts control, etc.
Perform other work-related duties as assigned.

Job Complexity:

The position manages a high level of complexity and focuses on issues of both tactical and strategic significance. Manages, develops and advises subordinates. Develops and administers budgets, schedules and performance requirements. Frequent interactions with external officials, external vendors, internal project teams and departments.

Supervisory Responsibilities:

Supervise internal professionals within the facilities department, including employees within the maintenance and trades. Responsible for supervision of contractors on site.

Experience, Knowledge, and Skills Required:

Bachelor's degree in engineering or life sciences or equivalent experience
5+ years of experience in pharmaceuticals or medical devices
3+ years in management / supervisor / leadership positions with direct personnel supervision is required for this role.
Minimum of 5 years of cGMP facility design, construction, and/or maintenance and a track record of managing successful capital improvement projects.
Strong leader and manager of teams with the ability to create high performance teams and develop employees to their full potential in a fast-paced environment.
Excellent analytical and problem-solving skills coupled with strong presentation skills. Excellent communication skills, both verbal and written.
High degree of integrity and professionalism with the ability to reach out and establish relationships across a global organization.

Anika Therapeutics

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Senior Manager, Facilities