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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.
Job Responsibility:
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
Requirements:
Doctorate degree OR Master's degree and 3 years of drug product manufacturing or operations experience OR Bachelor's degree and 5 years of drug product manufacturing or operations experience OR Associate's 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
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
Nice to have:
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 we offer:
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