Project Manager Cdmo Jobs in Raleigh, NC (NOW HIRING)

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

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The Manager, Facilities and Maintenance is accountable for driving results in a fast-paced environment by managing and overseeing the programs and personnel related to maintenance of the facility, process equipment, critical utilities, general facility utilities. This includes routine support of day-to-day operations as well as special projects. Special projects include customer centric projects, plant shutdowns, and facility upgrades, renovations, or expansions. The Manager, Facilities and Maintenance administers these programs and projects by assisting in the development of project plans, schedules, and provides oversight of the work during execution. All activities are conducted under the regulatory agency requirements of the pharmaceutical industry and related products that are manufactured at Alcami, such as FDA, DEA, and EU as examples.

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

• Provides leadership and direction to the Maintenance (GMP and Facilities).
• Plans and manages projects including facility/utility capital projects and other capital efforts.
• Ensures GMP compliance (e.g. deviation initiation and review, CAPA assignments, compliance reports, change control generation and review).
• Provides maintenance program oversight (preventative maintenance programs, repairs, spare parts program, pest control program, etc.).
• Reviews and provides oversight to the facilities maintenance work order creation, which includes troubleshooting and guidance.
• Responsible for utilities such as but not limited to HVAC, compressed air, WFI, Clean Steam, nitrogen, chilled water, etc.
• Manages bi-annual shutdowns.
• Owns site security, including maintaining the camera and badge reader systems at the site, maintaining the key control list and working with the Global Security Manager on implementation of security programs and site security plan.
• Maintains and broadcasts key metrics to management.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.
• Directly supervises team of 5-8 direct reports.
• Participates in the hiring process of other employees.
• Makes hiring decisions of other employees.
• Schedules and reviews the work of other employees.
• Accountable for the curriculum assigned and timely completion of training of employees to meet regulatory requirements.
• Coaches, mentors and develops other employees.
• Prepares and delivers performance evaluations of other employees.
• Make recommendations of disciplinary actions of other employees.
• Other duties as assigned.

• Bachelor’s degree (Engineering disciplines) required.
• 6 plus years of regulated (FDA, DEA, NRC, DOE, etc.) applicable experience required; 8 to 10 years preferred.
• Minimum of 3 years supervisory experience required.
• Prior pharmaceutical experience required; CMO or CDMO experience preferred.
• Experience in aseptic operations a plus.

• Expert knowledge of pharmaceutical facility operations and maintenance, and aseptic processing equipment.
• Knowledge of FDA regulated industry requirements, work order/calibration software, managing personnel, and EHS required.
• Excellent written and oral communication, coaching and mentoring skills required.
• Excellent ability to read and interpret engineering design, ability to read and understand equipment specifications and ability of track and trend data analysis required.
• Good negotiating skills required.
• Ability to manage a Maintenance team that works multiple shifts.

• Up to 10% domestic travel.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to frequently talk or hear. The employee is required some of the time to stand, walk, and sit. The employee is required to occasionally use hands to finger, handle, or feel; climb or balance; stoop, knell, crouch or crawl; reach with hands and arms; taste or smell. The employee must regularly lift and/or move up to 10 pounds, occasionally lift and/or move up to 50 pounds. There is no special vision requirement for this job. The employee may occasionally work in wet or humid conditions, near moving mechanical parts, in high precarious places, near fumes, airborne particles or toxic chemicals.