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Manager Manufacturing

Initial Therapeutics, Inc.

Manager Manufacturing What you will do The Amgen Thousand Oaks, building 20 Drug Product Manufacturing facility directly supports Amgen’s pipeline of clinical and commercial drug product supply to patients across the globe. The Manager Manufacturing Drug Product Inspection role offers the opportunity to collaborate with multiple functions within the Thousand Oaks site (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering, Regulatory Compliance, etc.) on a routine basis in a dynamic environment while developing a deep understanding of the manufacturing operations and planning activities within the facility. The Manager Manufacturing is responsible for developing a team of expert manufacturing associates and visual inspectors within Drug Product operations, while championing a safe and compliant production environment through structured on‑floor presence. In this position, the manager will ensure production areas and procedures remain in compliance with current Good Manufacturing Practices, set and measure team performance/goals, engage in production scheduling decisions, and work cross‑functionally to close nonconformance investigations and introduce new product SKUs. Responsibilities Staff selection, training, oversight, performance, and development. Schedule adherence for tasks including, but not limited to manufacturing, qualification, and maintenance activities. Participating as a role model in Lean culture and continuous improvement programs with responsibility to translate onto the manufacturing floor. Elevating critical and impactful events to senior management and making real time processing decisions. Ensuring standard operating procedures are accurate for performing unit operations, batch record review is completed accurately meeting disposition timelines, and non‑conformances are initiated & closed with right the first time documentation. Using appropriate systems for job duties (SAP, QMTS, and LIMS etc.). Identifying and implementing process and safety improvements. Communicating production floor and project work at different levels of management. Interacting with business partners and internal/external audit teams including regulatory agencies as required. Working with business partners to assist with the scheduling of maintenance tasks, engineering evaluations, and quality investigations. Supporting the introduction of new products and technologies into the facility. Troubleshooting and performing initial assessment of events that have the potential to impact area safety and product quality. Assessing departmental utilization to complete both near‑term schedule and long‑term strategy. Role will predominantly support a graveyard shift. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek will possess these qualifications. Basic Qualifications Doctorate degree OR Masters degree and 3 years of drug product manufacturing or operations experience OR Bachelors degree and 5 years of drug product manufacturing or operations experience OR Associates degree and 10 years of drug product manufacturing or operations experience OR High school diploma / GED and 12 years of drug product manufacturing or operations experience AND In addition to meeting at least one of the above requirements, you must have 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 At least 6 years of manufacturing experience, with 3 years of leadership experience directly within drug product manufacturing that includes inspection of product. Bachelor's or Master's degree in Life Sciences, Engineering, Business, Microbiology, or a related field. Strong understanding of lean concepts and application within a regulated manufacturing environment. Effective at working in fast‑paced environments, specifically in a leadership capacity to facilitate objective decision making. What you can expect of us From our competitive benefits to our collaborative culture, we 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. 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.

Vacancy posted 4 days ago
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