The Biochemistry Supervisor will supervise a team of skilled employees and will oversee the testing of raw materials, in-process antigens, and final product by immunological, colorimetric, and analytical assays. The supervisor will ensure products are tested in a manner consistent with Standard Operating Procedures and in compliance with regulations according to 9CFR.

·Supervise QC technicians, distribute work load, and monitor progress of biochemistry related testing

·Evaluate virus and bacteria by immunochemical assays for potency, identity, purity, and quality

·Assay various raw materials, in-process antigens, and final product for basic chemical compositions

·Perform titrations and identity testing of viruses or bacteria using ELISA calculations

·Perform extraneous virus testing by qPCR

·Ensure adherence to all SOP’s and documentation required to perform testing referenced above

·Ensure self and all direct reports are current on training required to perform testing referenced above

·Attend meetings to keep informed of manufacturing priorities and relay information to the department

·Lead/conduct investigations into out of spec results as necessary

·Performs personnel management functions including time sheet approvals, scheduling of vacations, personnel development, and performance evaluations

·Ensure that safety standards are maintained

·Support purchasing of materials for laboratory activities

·Shape solutions out of complexity - Accepts needs for flexibility

·Client focus - Responds appropriately

·Collaborate with empathy - Responds to cooperation requests

·Engage and develop - Values learning for oneself and others

·Drive ambition and accountability - Shows concern for reaching targets

·Influence others - Communicates clearly

·Audit – Ability to perform internal audits as a lead and external audits as part of the audit team

·Technical & Scientific Knowledge - Knowledge of technical and scientific pharmaceutical development, regulatory and manufacturing sciences in multiple fields.

·Processes & Organization Continuous Improvement – Ability to understand Ceva’s products and processes within area of operation and propose tools and resources for improvements and solutions

·Regulation Knowledge – Capacity to understand local and international regulations applied to area of operation.Knowledge of the specific technical standards, guidelines and tools, with the ability to challenge counterparts and adapt solutions

·IT Tools Mastery – Advanced level in use of office software

·QMS - Knowledge of quality system tools and ability to adapt them to the organization to meet quality standards requested by primary global regulations (GLP, GCP, GMP). Ability to present system tools during regulatory inspections

·Education – Bachelor’s degree in Microbiology, Veterinary Science or equivalent

·Work Experience – 5 years in Quality in veterinary biologics industry. Have a working knowledge of 9CFR and APHIS regulations. Must have working knowledge of biochemistry testing methods traditionally used in QC laboratories.

·Ability to perform repetitive motions and stand for extended periods of time

·Must be able to read, write and communicate in English

·Visual inspection

·Position located at the Biomune Lenexa campus in the quality control laboratory

Minimal if required

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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