Site Head, Sterile Operations

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 Manufacturing Head of Sterile Operations is accountable for driving results in a fast-paced environment by directing operations for Alcami's parenteral site. The Head of Sterile Operations develops site-wide production and resource plans, and manages key performance metrics to manage and meet production goals. As the Manufacturing Sterile Site Head, talent management and succession planning are critical deliverables. This role ensures proper staff training and development to achieve results or proactively manages expectations towards alternative solutions. The Site Head develops and implements key strategic policies and procedures to address complex problems requiring in-depth analysis and independent judgment within broadly defined practices and policies. The Head of Manufacturing engages with business development to provide key support of strategies to grow accounts and business relationships.

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

• Collaborates with executive and site leadership teams to communicate strategic direction and ensure the sterile site's performance meets the expectations of customers (internal and external) and supports the achievement of broader company goals.
• Develops production and resource plans across multiple groups and manages key performance metrics to optimize efficiency and meet production goals in terms of safety, quality, output, and cost. Drives revenue and manages spending.
• Engages with business development to provide key support growth and development of the product portfolio and business relationships including project definition and costing.
• Prepares and delivers presentations for various audiences including the site, external customers, executive leadership team, and industry leaders. Communicates effectively with external customers and internal groups.
• Identifies, recommends, and implements new processes, technologies, and systems to improve and streamline organizational processes and use of resources and materials.
• Develops and implements key strategic policies and procedures to address complex problems and to meet current and forthcoming compliance and operational requirements requiring in-depth analysis and independent judgment within broadly defined practices and policies.
• Drives organizational development and fosters a results-oriented, customer-focused culture of accountability. Promotes a safe working environment in compliance with local and national safety regulations.
• Ensures proper staff training and development to ensure results are acheived or expectations are proactively managed towards alternative solutions.
• 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.
• Other duties as assigned.

• Minimum of 15 years of experience, including 5 years in upper management in a sterile parenteral GMP/FDA regulated pharmaceutical company.
• Must have extensive experience in sterile CMO operations, including technical transfer, qualification, validation, trouble shooting, Regulatory and Customer inspections, process scales-up, and commercial operations.

• Strong business acumen.
• Strong knowledge of FDA, EU, and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry.
• Prior pharmaceutical or CDMO experience in technical functions of development or manufacturing.
• Excellent written and verbal communication and presentation skills required.
• Excellent project management, organization skills and ability to effectively multi-task required.
• Excellent problem solving and critical thinking skills required.
• Results-orientated, determined, and a self-starter; comfortable, willing, and able to make cold calls.
• Ability to work independently in a fast-paced and dynamic environment.
• Ability to build and grow strong customer relationships and ability to influence others.
• Ability to develop and manage a high-performance team focused on quality, accountability and exceeding expectations.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.
• Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
• Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
• Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
• Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
• Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
• Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless of where ideas originate. Flexible and easy to work with.

• Up to 10% travel typically.

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 regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move assisted up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet.