Sr. Manager Manufacturing
Manufacturing | Irvine, CA | Full Time
Siegfried Irvine is a full service cGMP, FDA, MHRA and ISO13485 drug, device and combination product contract manufacturer providing developmental, clinical and commercial contract manufacturing services to large and small organizations, headquartered in Irvine, California.
We have an immediate need for a: Sr. Manufacturing Manager
Siegfried Irvine specializes in difficult to manufacture formulations that include solutions, suspensions, emulsions, sterile ointments and gels with the capability to fill an array of container closures. Siegfried Irvine has extensive manufacturing capabilities and maintains state of the art micro and analytical laboratories, and the capability to provide stability services meeting all ICH guidelines. Our commitment to Quality and Patient Safety is enduring and uncompromising.
Scope and Purpose of Position
Responsible for the management of the daily operations (products and people). Ensuring the adherence to all regulatory and safety requirements and fulfilling manufacturing output, quality and time requirements. Develop and maintains a team environment with high levels of participation from all Manufacturing associates.
Meet established department goals and measures, including productivity, labor and scrap Maintain budgetary expenses, commensurate with ongoing business volumes Lead Site Business Excellence initiatives Ensure staffing of manufacturing organization is in place to meet production demand Responsible for scheduling and supervising designated operations Participate in planning manufacturing activities Perform SAP transactions on each batch, including review and labor tracking Ensures that personnel are effectively utilized to meet manufacturing needs and achievement of KPI’s Ensure compliance with regulatory and industry standards, safety rules and applicable company policies and procedures Utilize human resources effectively, train and coach and provide developmental opportunities for personnel to increase cross training and scheduling flexibility Evaluate the performance of personnel; recommend salary and or promotional actions. Take appropriate actions to resolve marginal performance. Maintain a positive working environment that encourages personnel participation, team work and mutual support Coordinate activities with Materials Management, QA and Engineering to ensure manufacturing, productivity and quality standards are met. Responsible to implement safety policies and ensure that personnel are trained in and follow safe work procedures Ensure proper maintenance and work place organization of equipment and work areas Seek input and guidance on complex problems or new activities, with implementation of agreed upon approaches Solve and trouble shoot routine daily operations problems. Make decisions that ensure the quality and integrity of the product that is manufactured and maintained Any and all other duties as assigned by immediate supervisor
Required Knowledge, Skills and Abilities
- Demonstrated leadership skills
- Understanding of lot control relative to medical industry
- Understanding of Good Manufacturing Practices and ISO Standards
- Demonstrated communication and interaction skills
- Computer literate with solid presentation skills, Excel, MRP (SAP)
- Ability to handle multiple tasks, interact with numerous departments
- Ability to train other, apply Lean, 5S applications for efficient operations
- Ability to work independently
Required Education and Experience
- 4-year college degree Engineering or Science preferred
- Equivalent combination of education and work experience accepted
- 5-7 years’ industry experience directly associated with aseptic manufacturing
- 5 or more years’ experience in a supervisory role of a large team environment
Siegfried Irvine offers competitive pay, bonus program, medical, dental, vision, Co. Paid Life, LTD, STD, and Buy Up options. 401K (with match), Employee Share Purchase Program (ESPP). Our time off includes a holiday schedule, vacation accrual and sick time.