Provide support to the Focus Factory Leader by serving as a front-line supervisor within the department and directing the team leaders in order to ensure delivery of a quality product, in a timely manner, while maintaining a safe working environment.

The Laboratory Support department consists of four areas:

• Material receiving and handling - receiving supplies from our internal warehouse while ensuring materials are QA released for use

• Dishware Preparation and Sterilization - wash and prep dishware and sterilize via autoclave

• Freezing - prepping materials for filling product, handling final product from the filling line, visual inspection of final product and freezing and storing of product with liquid nitrogen

• Labeling - printing and labeling final product vials

• Hire, train, motivate, coach and develop staff for job mastery and advancement

• Ensure team leaders have all equipment and raw materials prepared and ready for daily use; making sure all raw materials are released prior to use

• Assists with employee development planning and helps employees with fulfillment of development plans

• Assist in production planning and scheduling

o Assign staff activities

o Meet scheduling requirements

o Be the primary conduit for reporting issues arising from the Manufacturing floor

• Review and manage documentation for batch and system records and standard operating procedures

• Conduct regular reviews of standard operating procedures and batch record documentation and identify areas for improvement; ensure documentation is detailed, accurate and completed concurrently with the process

• Inspect USDA approved labels prior to printing and labeling

• Inspect USDA approved labels prior to freezing the final product

• Lead and coach the team towards identifying and implementing process improvements; develop and maintain KPI’s

• Oversee inventory areas, ensure daily cycle counts are being performed correctly

• Ensure inventory transactions are being completed in a timely manner and run appropriate inventory accuracy reports

• Accountable for a safe working environment

o Instills a culture of safety

o Ensures safety standards, procedures and processes are followed by the manufacturing staff and potential deviations are communicated and escalated appropriately

o Takes ownership that improvements are robustly implemented and reviews the need for further actions

o Ensure areas are clean and orderly

o Ensure material handling area is following company policies and procedures

• Identify processes to determine efficiencies and identify root causes for inefficiency and implement changes as needed based on assessments

• Resolves problems that may impact production deadlines

• Provide guidance and help to lead trouble shooting efforts as needed during a deviation in the process

• Ensure open communication is being done by self and staff in order to coordinate production tasks

• Assist other departments as needed

• Assist in getting other departments supplies they require

• Assist with all bench tasks as needed

• Review all Purchase Orders for accuracy

• Ensure equipment and facility validations and calibrations are performed as required

• Shape solutions out of complexity - Is open and curious of others perspectives

• Client focus - Has in mind clients satisfaction

• Collaborate with empathy - Has a positive attitude towards collaboration

• Engage and develop - Clarifies short-term directions

• Drive ambition and accountability - Proactively manages own and others work

• Influence others - Communicates transparently

• Demonstrates continuous leadership ability and quality

• Flexible to complete necessary tasks with last minute changes to the production plan and multi-tasking of priorities

• Demonstrated training abilities

• Excellent communication skills, both verbal and written

• Self-motivated and can work with minimal supervision

• Exercise rapid learning ability

• Strong attention to detail

• Excellent computer skills; familiarity with Microsoft Office and Google Suites

• Organized analytical thinker with high level of energy

• Must be able to work in a team environment

• Ensure compliance of all manufacturing processes in accordance with Regulatory Agencies (USDA, OSHA) as well as Ceva policies, procedures, goals and objectives

• Follow all relevant department policies, procedures, SOPs, and other requirements during project execution

• Strong math skills

• Education - Bachelor's Degree in a scientific field (i.e. chemistry, general biology, cellular biology, microbial biology, etc.) or at least 5 years experience in related field

• Work Experience - 4 to 6 years experience in the biologics industry, 2 or more years of managerial/supervisory experience in the biologic/pharma industry

• Other: Knowledge of Quality Systems; investigations/CAPAs, performing gap assessments

• Able to read, write legibly and communicate in English

• Standing for long periods of time

• Frequent repetitions of bending, twisting, lifting arms above head, wrist and shoulder movements

• Visual inspection

• Dexterity: Frequent fine motor movement

• Lifting 50 lbs

• Daily dressing and operating in clean room required garments and PPE

• Frequent work in -196°C storage tanks for more than one hour

• N/A

This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job. This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job. This job description is not an employment contract. Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.

• VEVRAA Federal Contractor

**Ceva is an equal opportunity employer and all qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, age, genetic information, actual or perceived sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. Ceva encourages men and women, members of all racial and ethnic groups, individuals with disabilities and veterans to apply.

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