Director, Technical Operations - #1341511

Piramal Pharma Ltd


Date: 1 week ago
City: Lexington, KY
Contract type: Contractor
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Job Description

Key Responsibilities

  • Successful achievement of revenue related targets and identification of new revenue opportunities
  • All operational aspects of manufacturing, including: productivity, cost, planning, daily business processes, cGMP compliance
  • Key contributor to positive client relationships by ensuring adherence to customer requirements/specifications, open communication, and resolution of any issues
  • Evaluation of potential new clients, vetting of project scope and technical capabilities
  • Ensure successful technological transfer of new products developed from R&D to clinical/commercial manufacturing and commercial site transfers
  • Facilitate alignment of technical services, engineering, maintenance, and production operations to minimize downtime, improve processes, and improve quality
  • Establish demand plan and detailed schedule, articulate key financial milestones for forecast
  • Drive manufacturing technology, automation, and facility strategies
  • Lead, coach, and provide direction to direct reports, as well as indirect reporting relationships
  • Management of the corporate CapEx budget, ensuring capital investments are appropriately executed
  • Management and oversight of multiple departmental budget(s)
  • Collaborate with Project Management team to ensure that technical operations’ resources are effectively deployed and meet client expectations
  • Collaborate with Quality/Validation to support the validation lifecycle of all equipment, utilities, facilities, systems and processes
  • Skip-level oversight of the engineering, maintenance, calibration and operations functions, including: project and process engineering, instrumentation, control systems, automation, and preventative maintenance systems
  • Establish and track the relevant KPIs to improve the efficiency and quality of the entire GMP operation
  • Partner with Business Development, Project Management, R&D, and Quality Leadership teams to ensure compliance within the quality system

Qualifications

Education Requirements:

  • Bachelor's Degree in applicable scientific field, including: Mechanical, Biological, or Chemical Engineering, Operations Management, or Life Sciences

Work Experience

  • Minimum fifteen (15) years working within pharmaceutical manufacturing environment, must include aseptic filling/lyophilisation experience
  • Contract Development & Manufacturing
  • Formal leadership experience, including P&L responsibility, revenue achievement, and talent management activities

Functional Or Technical Skills

  • Expertise in sterile manufacturing
  • In-depth knowledge of Engineering activities, including: developing specifications, facility design, product development, project portfolio management
  • Thorough working knowledge of cGMPs, including: FDA, JP, and EU regulations
  • Proficiency and understanding of cGMP quality systems, including: CA/PA, root-cause analysis, risk assessment and investigation tools and techniques
  • Demonstrated success in leading cross-functional teams and achieving goals
  • Tactful communication skills, both written and verbal
  • Proven track record of forging positive working relationships with other leadership team members and use influence to achieve site goals
  • Understanding of typical CDMO for service contracts and legal agreements
  • Ability to understand cultural differences and modify behaviors to support global customer relationships
  • Understanding of isolator technologies

Job Info

  • Job Identification 5207
  • Job Category Operations
  • Posting Date 05/06/2024, 03:07 AM
  • Job Schedule Full time
  • Locations 1500 BULL LEA ROAD,, Lexington, KY, 40511, US

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