Supervisor, Packaging Operations - Pharma

Gilead SciencesLa Verne, CA
5d

About The Position

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Basic Requirements: 6+ years of relevant experience and a BS or BA. 4+ years of relevant experience and a MS. Preferred Requirements: Prior experience in a cGMP related industry is desirable, within Biopharmaceutical or Pharmaceutical industry preferred. Acts as a mentor to junior staff with some task management responsibility Personnel management of a team or shift May lead a special project team within the unit/function. May serve as a team representative on cross functional projects in support of more senior colleagues in the function. This is an advanced position requiring significant expertise/specialization in area of work. Works on complex issues where analysis requires an in-depth assessment, considering many variables, and potential consequences. Demonstrates proficiency in regulatory affairs and applies knowledge to processes. Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed. Exercises judgment within well defined and established procedures and practices to determine appropriate action with minimal supervision. Develops solutions to moderately complex problems and conducts final reviews prior to batch release approval by manager Supervises personnel including organizing and prioritizing daily tasks, performing training and writing performance reviews Plans/schedules packaging line equipment and staffing to meet production requirements. Responsible for line output, performance and quality Time in position does not automatically qualify an employee for promotion. Demonstrates advanced technical knowledge. Demonstrated success in leading projects and applying problem solving skills. Demonstrates the ability to clearly and concisely present/ explain process/product features, performance and deviations to multiple internal audiences. Demonstrates an ability and desire to supervise and support junior staff. Demonstrates an ability to communicate effectively with peers in organization. Demonstrates the ability to think outside of the process and consider the impact decisions will have on other areas. Demonstrates an ability and desire to manage and support junior staff Project Management Management theory Supply chain management training/knowledge Project Mgmt including process improvements such as Six Sigma/Kaizen Begins to pursue training in an area of specialization Human Resource Management Provides hands-on guidance to lower level Packaging Technicians. Has daily contact with Compliance, Inventory Control and Maintenance to ensure equipment and materials are ready and available for use. Investigates and reports variance or deviation from standard procedures to department management. Conducts Technicians’ performance evaluations and one on one meetings Assigns daily job responsibilities. Expedites production scheduling through communication with QA/QC and Inventory Control personnel. Participates in production processes, including cleaning and set-up. Complies with all established SOPs in performance of job; adheres consistently to GMPs. Proficient knowledge of Good Manufacturing Practices (GMPs) Audit and Investigation Skills, Report Writing Skills. Strong verbal, technical writing and interpersonal skills are required. Proficiency in Microsoft Office applications. Must possess a strong knowledge of the FDA and cGMP standards as well as regulatory guidance documents.

Requirements

  • 6+ years of relevant experience and a BS or BA.
  • 4+ years of relevant experience and a MS.
  • Demonstrates advanced technical knowledge.
  • Demonstrated success in leading projects and applying problem solving skills.
  • Demonstrates the ability to clearly and concisely present/ explain process/product features, performance and deviations to multiple internal audiences.
  • Demonstrates an ability and desire to supervise and support junior staff.
  • Demonstrates an ability to communicate effectively with peers in organization.
  • Demonstrates the ability to think outside of the process and consider the impact decisions will have on other areas.
  • Demonstrates an ability and desire to manage and support junior staff
  • Project Management
  • Management theory
  • Supply chain management training/knowledge
  • Project Mgmt including process improvements such as Six Sigma/Kaizen
  • Begins to pursue training in an area of specialization
  • Human Resource Management
  • Proficient knowledge of Good Manufacturing Practices (GMPs)
  • Audit and Investigation Skills, Report Writing Skills.
  • Strong verbal, technical writing and interpersonal skills are required.
  • Proficiency in Microsoft Office applications.
  • Must possess a strong knowledge of the FDA and cGMP standards as well as regulatory guidance documents.

Nice To Haves

  • Prior experience in a cGMP related industry is desirable, within Biopharmaceutical or Pharmaceutical industry preferred.
  • Acts as a mentor to junior staff with some task management responsibility
  • Personnel management of a team or shift
  • May lead a special project team within the unit/function.
  • May serve as a team representative on cross functional projects in support of more senior colleagues in the function.
  • This is an advanced position requiring significant expertise/specialization in area of work.
  • Works on complex issues where analysis requires an in-depth assessment, considering many variables, and potential consequences.
  • Demonstrates proficiency in regulatory affairs and applies knowledge to processes.
  • Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.
  • Exercises judgment within well defined and established procedures and practices to determine appropriate action with minimal supervision.
  • Develops solutions to moderately complex problems and conducts final reviews prior to batch release approval by manager
  • Time in position does not automatically qualify an employee for promotion.

Responsibilities

  • Supervises personnel including organizing and prioritizing daily tasks, performing training and writing performance reviews
  • Plans/schedules packaging line equipment and staffing to meet production requirements.
  • Responsible for line output, performance and quality
  • Provides hands-on guidance to lower level Packaging Technicians.
  • Has daily contact with Compliance, Inventory Control and Maintenance to ensure equipment and materials are ready and available for use.
  • Investigates and reports variance or deviation from standard procedures to department management.
  • Conducts Technicians’ performance evaluations and one on one meetings
  • Assigns daily job responsibilities.
  • Expedites production scheduling through communication with QA/QC and Inventory Control personnel.
  • Participates in production processes, including cleaning and set-up.
  • Complies with all established SOPs in performance of job; adheres consistently to GMPs.

Benefits

  • This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
  • Benefits include company-sponsored medical, dental, vision, and life insurance plans.
  • For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
  • Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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