Senior Manager Manufacturing

Company: Initial Therapeutics, Inc.
Location: Thousand Oaks
Posted on: February 1, 2025

Job Description:

Join Amgen's Mission of Serving PatientsAt Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Senior Manager ManufacturingWhat you will doLet's do this. Let's change the world. In this vital role, you will be responsible for oversight of several areas of the GMP plant for Drug Product at the Thousand Oaks campus.Responsibilities:Leadership & Team Management:

• Lead and mentor the manufacturing process owners within the manufacturing department.
• Foster a culture of collaboration, continuous improvement, and high performance across teams.
• Develop and implement training programs to enhance the capabilities of manufacturing personnel.
• Provide guidance, performance evaluations, and support career development plans for direct reports.Manufacturing Operations Management:
  • Ensure smooth collaboration and coordination between various departments (e.g., Quality, Facilities and Engineering, Automation, Supply Chain, Maintenance) to optimize plant performance.
  • Manage and improve manufacturing processes to increase productivity and reduce waste while maintaining product quality and compliance.Quality, Compliance & Regulatory Oversight:
    • Ensure that manufacturing activities are in compliance with cGMP (current Good Manufacturing Practices), FDA, EMA, and other applicable regulatory standards.
    • Support efforts in preparing for regulatory audits and inspections, ensuring adherence to all required documentation and protocols.
    • Ensure adherence to our safety culture and support a safe working environment for all manufacturing employees.Process Optimization & Continuous Improvement:
      • Lead process improvement initiatives aimed at increasing efficiency, reducing costs, and enhancing the drug product manufacturing process.
      • Utilize lean manufacturing principles, Six Sigma, and other continuous improvement tools to optimize manufacturing operations.
      • Analyze manufacturing data to identify trends, solve complex operational challenges, and implement corrective actions as needed.Collaboration & Cross-Functional Communication:
        • Partner with other departments (e.g., Quality Assurance, Facilities & Engineering, Automation, Supply Chain) to ensure that production requirements are met and new product introductions are smoothly integrated into the manufacturing process.
        • Act as the point of contact for process owners during troubleshooting and resolution of manufacturing-related issues.Technology Integration:
          • Stay up to date with technological advancements in the industry and assess their potential for implementation in the plant.
          • Support the introduction and scale-up of new technologies, equipment, and systems to enhance production capabilities.What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek is a collaborative partner with these qualifications.Basic Qualifications:Doctorate degree and 2 years of Manufacturing and Operations experienceOrMasters degree and 6 years of Manufacturing and Operations experienceOrBachelors degree and 8 years of Manufacturing and Operations experienceOrAssociates degree and 10 years of Manufacturing and Operations experienceOrHigh school diploma / GED and 12 years of Manufacturing and Operations experienceIn addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.Preferred Qualifications:
            • Bachelors Degree in Life Sciences, Physical Sciences, Engineering or Process Manufacturing
            • 8+ years of related lab, manufacturing or healthcare operational experience.
            • 6+ years of leadership experience with 2 or more years as a cross-functional team leader including experience in performance management, technical problem solving, and managing projects (or equivalent/lateral experience).
            • 4+ years experience with a compliant highly regulated organization, cGMP or other, including advancing compliant operations.
            • Technical writing experience
            • Staff and team development.
            • Able to recommend, judge, and make good decisions in complex situations.
            • Able to positively advance the culture of an organization.
            • Managing and coaching conflict effectively.
            • Overall understanding of mechanical, technical and operational systems.
            • Budgeting, goal setting, capacity planning, inventory control, lean principles, value stream mapping.
            • In-depth business understanding of manufacturing or operations in biotechnology / biopharmaceuticals / pharmaceuticals industry.What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
              • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
              • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
              • Stock-based long-term incentives
              • Award-winning time-off plans
              • Flexible work models, including remote and hybrid work arrangements, where possibleApply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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Keywords: Initial Therapeutics, Inc., Los Angeles , Senior Manager Manufacturing, Executive , Thousand Oaks, California