Senior Supervisor, Aseptic Operations - Lyophilized Product Manufacturing (Night)

Hillsboro, Oregon
United States

Job ID: 3416543431

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The Position

*** Please note this is currently a Night Shift position, Wed through Friday and every other Saturday from 6:00am to 6:30pm ***


Under thedirection of the Filling Production Manager, the Aseptic Operations Supervisorwill be accountable for Aseptic Production Operations of liquid or lyophilizedproducts, including capping, tray-off and Automated Inspection.  Includingoverseeing drug substances thaw/compounding process and small part autoclavingand sterilization.  In addition to managing the responsibilities below,the successful candidate will need to demonstrate the following traits.

  • Able to collaborate with both plantand corporate organizations seamlessly
  • Has the passion and drive to developand maintain a LEAN culture dedicated to providing the best results for ourinternal and external customers
  • Embraces World Class principles andbehaviors
  • Is constantly in search of the mostcreative and innovative solutions to maintaining the highest levels ofproductivity
  • Is able to provide the leadershipnecessary to maintain a high performance culture  
Responsibilities:
  • Ensure work environment meetsGenentech and industry standards
  • Create and maintain a safety culturethat delivers injury and incident free operations
  • Drive achievement of departmentalsafety performance targets and manage operations so that all departmental,functional and site objectives are met
  • Reinforce safety practices/behaviorsthroughout the shift
  • Provide oversight and support toensure safety improvement initiatives are consistently identify and implemented
  • Ensuring that all shift personnelhave applicable safety training requirements assigned and completed
  • Ensure the facility is alwaysregulatory inspection-ready
  • Participate in the development ofquality goals and oversee operations to ensure targets and objectives areachieved
  • Review trend data to ensure qualitycompliance and correct negative trends as required
  • Reinforce quality practicesthroughout the department
  • Provide oversight and support toensure adequate quality improvement initiatives are appropriately identifiedand implemented in a timely manner
  • Maximize production output and laborefficiency while meeting required safety and quality levels
  • Manage operations to ensure thatproduction, productivity, and financial targets and objectives are met
  • Ensure business processes arefollowed and improved to deliver production performance at Class A levels
  • Maximize equipment utilization andOverall Equipment Effectiveness (OEE)
  • Apply operational excellence toolsto define standard work, reduce process variability and steadily delivermeasurable efficiency gains
  • Ensure that Continuous ProcessImprovement teams are supported, trained and facilitated
  • Manage the execution of theproduction schedule and shop order sequencing to optimize use of availablecapacity
  • Maintain data and transactionalsources required to support capacity models to understand real time capacityutilization and capability
  • Comply with all company policies andprocedures related to personnel management
  • Manage and mentor the performanceplanning process for all direct reports to ensure their success Coach anddevelop leads, specialists and technicians via effective development planning
  • Coordinate shift level hiring andstaffing plans
  • Complete all required trainingactivities (i.e., safety, cGMPs, technical skills, processing operations, etc)
  • Ensure lessons learned or bestpractices are shared across the department
  • Leverage knowledge to maximizeorganizational effectiveness
  • Identify and manage the developmentand implementation of novel approaches to solving complex technical problemswhile maintaining required levels of safety, quality (including regulatorycompliance), and production
  • Actively manage shift labor,overtime and spending to within the approved budget on an ongoing basis
  • Review and approve manufacturingdocumentation including batch records and SOPs. Review and support closure ofdiscrepancy records
  • Participate in strategic planning, objectiveself analysis for compliance, safety and quality risks, and analysis ofoperational strengths, weaknesses, opportunities and threats

Who You Are

Requirements/Qualifications:
  • Bachelors degree in a science orengineering discipline or equivalent
  • Demonstrated ability to managepeople and projects. Ability to work with internal teams, partners, suppliersand customers
  • Excellent written/spoken communicationand interpersonal skills
Desired:
  • Possess a minimum of 5 years ofprogressively responsible experience in pharmaceutical manufacturing andspecific experience in parenteral manufacturing
  • Current understanding of FDA and EMAguidelines, cGMP’s for Manufacturing Parenteral Drug Products, includingvalidation requirements
  • Operational Excellence andIndustrial Engineering skills
  • Proficiency with validated changemanagement, discrepancy management, inventory management, and productioncontrol systems
 

Currentlythis position is on D Shift, which is a compressed night shift on the back halfof the week. Work hours for this shift are currently Wed, Thursday, Friday andevery other Saturday night from 18:00 to 06:00.

Theshift is subject to change based on the needs of the business. 


Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.


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