Start-Up Manager: New Product Drug Manufacturing

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Start-Up Manager: New Product Drug Manufacturing

Noblesville, Indiana

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Full Time

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$ 55 - $ 63 per hour

Noblesville, Indiana

Full Time

$ 55 - $ 63 per hour

July 10, 2024

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Job ID: LS 1382066 AB_1720622406

July 10, 2024

Job ID: LS 1382066 AB_1720622406

Job Summary

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The identified individual will be responsible for supporting and implementing projects related to business strategy in the space of new product drug manufacturing. The Startup Manager will report to the Director of Operations. This role has the responsibility and accountability of implementing New Product projects in support of the client's growth strategy in the leading edge of radiopharmaceutical diagnostic and therapeutic sterile drug products designed for critical-to-life indications. Projects can include technical transfer, drug development, conceptual design, scoping and estimation, integration, etc. The Startup Manager will be responsible for coordinating activities between R&D, engineering, quality assurance, quality control, validation, and manufacturing up to and including commercial product launch.

Essential Functions

  • Support and/or lead large cross-functional projects and project teams through process evaluation, design, and implementation of robust processes
  • Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)
  • Product start-up manager responsible for coordinating product launch activities
  • Identify strategy, develop and execute startup plans
  • Technical and operational oversight for startup teams
  • Work collaboratively with the Project Manager to quickly move projects from scoping to implementation
  • Provide Aseptic Manufacturing expertise and guidance of the evaluation and design of new processes
  • Partner with Quality Leadership to ensure good quality and cGMP practices and their implementation in new product launch
  • Ensure the manufacturing department is prepared to meet commercial demand once the product is launched
  • Provide and maintain forecast estimates for project-related costs, resource hours, and general project task tracking for adherence to project milestone goals
  • Technical evaluation of new products relative to current site processes; process design for new products within existing or new manufacturing equipment

Requirements

  • Bachelor's degree in Chemistry, Engineering, or related field
  • 12 or more years of experience in pharmaceutical manufacturing with at least two years of leadership experience.
  • Experience as product start-up manager responsible for coordinating product launch activities
  • Experience in the optimization of processes, including the establishment of process KPIs
  • Strong project management and organizational skills, including the ability to manage the work of direct and indirect teams as well as provide individual contributions as a member of a larger team
  • Experience with radiation safety programs preferred
  • Subject Matter Expert knowledge of aseptic technique, regulatory requirements, and validation activities needed for manufacturing parenteral products
  • Ability to read PFDs and PIDs
  • Knowledge of current industry practices and technologies
  • Familiar with project management tools and best practices
  • Proven ability in setting priorities and organizing work to meet deadlines
  • Technical understanding of the pharmaceutical development process from concept to launch
  • Proven experience in leading complex multi-discipline project teams in a highly regulated environment
  • Strong oral and written communication skills with a proven ability to communicate effectively in high-pressure environments
  • Ability to react to problems and lead the team to develop solutions while communicating effectively with the executive team
  • Ability to maintain collaboration in a results-driven environment
  • Agile approach and willingness to learn new things - the ability to work "on the fly" in a dynamic setting
  • Advanced skills with Microsoft Office (Excel, PowerPoint, SharePoint, Word), MS Project, and Visio
  • Travel may be required up to 5% of the time
  • Experience managing projects with Smartsheet (preferred but not required)
  • Lean and/or Six Sigma certification preferred

LS 1382066 AB_1720622406

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About Beacon Hill

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

We look forward to working with you.

Beacon Hill. Employing the Future™