Senior Manager Manufacturing Production Process Owners
Initial Therapeutics, Inc.
Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Manager, Manufacturing Programs Production Process Owners What you will do Lets do this. Lets change the world! In this vital role you will be a people leader and cross-functional integrator responsible for end-to-end process governance and execution support within Drug Product Supply operations at the Thousand Oaks campus. This role ensures the site maintains a strong operating system for manufacturing readiness, technical governance, issue resolution, and continuous improvement across multiple unit operations and enabling processes, with accountability for driving alignment across key site forums, priorities, and decision-making bodies. Key Responsibilities Leadership & Team Management Lead, coach, mentor, and develop the manufacturing process owners within the manufacturing organization. Foster a culture of collaboration, continuous improvement, accountability, and high performance across the team. Provide guidance, performance feedback, and support for career development plans for direct reports. Set clear priorities, define role clarity, and establish coverage plans so the PPO team can flex across site needs, emerging issues, and evolving operational demands. Manufacturing Operations Management Ensure strong collaboration and coordination between Manufacturing and key partners such as Quality, Facilities and Engineering, Automation, Supply Chain, Maintenance, and other site functions. Provide governance and execution support to ensure smooth, compliant, and reliable manufacturing operations. Manage and improve manufacturing processes to increase productivity, reduce waste, and maintain product quality and compliance. Strengthen process discipline, documentation quality, and operational readiness across site processes. Serve as an escalation point for complex execution topics, ensuring issues are evaluated, decisions are made with the right stakeholders, and actions are closed with discipline. Quality, Compliance & Regulatory Oversight Ensure manufacturing activities are performed in compliance with cGMP and all applicable regulatory requirements and internal quality standards. Support inspection and audit readiness by ensuring appropriate documentation, escalation pathways, and governance transparency. Support site teams that own compliance-critical programs, including aseptic compliance and validation-related execution, by helping prioritize resources and drive timely resolution of issues. Ensure disciplined execution and timely closure of quality actions, CAPAs, and effectiveness verification activities in partnership with Quality and subject matter experts. Support and reinforce a strong safety culture and a safe working environment for all employees. Process Optimization & Continuous Improvement Provide oversight and drive process improvement initiatives aimed at increasing efficiency, improving reliability, reducing costs, and enhancing the drug product manufacturing process. Use lean manufacturing and other continuous improvement tools to identify opportunities and optimize operations. Analyze operational and quality data to identify trends, solve complex problems, and implement corrective actions. Collaboration & Cross-Functional Communication Partner with site stakeholders to ensure readiness for new processes, new products, and major operational changes. Support risk identification, issue resolution, and execution readiness across impacted functions and unit operations. Facilitate, or ensure strong facilitation of, key site governance forums used to align priorities, remove barriers, and drive execution. Support the site project governance operating model, including plant project prioritization, by driving disciplined intake, prioritization, execution tracking, and escalation when needed. Act as a point of contact for process owners during troubleshooting and resolution of manufacturing-related issues. Technology Integration Stay current on technological advancements and assess opportunities for adoption in the plant. Support introduction and scale-up of new technologies, equipment, and systems that enhance production capabilities and improve operational performance. Partner cross-functionally to ensure technology-related changes are effectively planned, implemented, and sustained What we expect of you We 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 experience OR Masters degree and 6 years of Manufacturing and Operations experience OR Bachelors degree and 8 years of Manufacturing and Operations experience OR Associates degree and 10 years of Manufacturing and Operations experience OR High school diploma / GED and 12 years of Manufacturing and Operations experience In 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 or 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 a related technical discipline. 8+ years of manufacturing, operations, technical operations, or process support experience in biotechnology, biopharmaceutical, pharmaceutical, or other highly regulated manufacturing environments. 6+ years of leadership experience, including direct people leadership and/or leadership of cross-functional teams, programs, or site-level initiatives. 2+ years of experience managing, coaching, or developing direct reports, technical teams, process owners, or matrixed contributors. Experience in Drug Product manufacturing operations, including aseptic processing, filling, inspection, packaging, validation execution, or manufacturing readiness. Strong working knowledge of cGMP operations and quality systems, including deviations, CAPAs, change control, effectiveness verification, audit/inspection readiness, SOPs, batch records, and controlled documentation. Demonstrated ability to lead governance forums, drive cross-functional alignment, prioritize competing site needs, and ensure disciplined follow-through on actions and commitments. Experience troubleshooting complex manufacturing, technical, quality, or operational issues in partnership with Quality, Engineering, Automation, Supply Chain, Maintenance, Facilities, and Technical Operations. Demonstrated ability to analyze operational and quality data, identify trends, drive root cause analysis, and implement sustainable corrective and preventive actions. Experience applying lean manufacturing, operational excellence, value stream mapping, capacity planning, waste reduction, or continuous improvement tools to improve manufacturing performance. Strong technical writing and communication skills, with the ability to translate complex technical and operational topics into clear decisions, actions, and governance updates. Experience supporting implementation or sustainment of manufacturing technologies, automation systems, digital tools, MES/electronic batch records, data visualization platforms, or process monitoring systems. Demonstrated ability to make sound decisions in complex, ambiguous, and highly regulated environments while balancing safety, quality, supply, compliance, and business priorities. Proven ability to build trust, manage conflict effectively, influence without authority, and positively advance the culture of an organization. Strong business acumen, including experience with goal setting, resource planning, budget awareness, inventory control, performance metrics, and manufacturing operating systems. What you can expect of us As 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, well 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 where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. In 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. 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. #J-18808-Ljbffr Initial Therapeutics, Inc.
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