Avid Bioservices Careers

Description

• Manage all Quality Control product release, stability, microbiology, and raw materials testing, as well as method development.   

• Responsible for modernizing the QC laboratory to update and outfit the lab with the latest analytical, build out of new lab space, and implementation of laboratory systems such as LIMS, SDMS and CDS as business priorities are aligned with IT and fiscal capability.
• Key member of the Analytical Development leadership team to define analytical development strategies and technology roadmap. Lead analytical method development & optimization, product characterization and method transfer to Quality Control. Provide supervision for method transfer and oversee QC activities as needed.   
• Review or approve method description and SOPs; address analytical issues in QC in collaboration with quality and client teams.
• Support CMC projects for internal and external clients and may be involved either directly or peripherally with CMC teams.  Support IND/IMPD/BLA batch release and stability sections for client regulatory filings.
• Identify potential new clients for business development and participate in client calls as an SME, as appropriate.
• Write and review Quality documents and ensure that appropriate documents are present in the Quality Control and Assurance SOP’s and other controlled documents.
• Ensure all personnel in the QC Department are appropriately trained and that training is appropriately documented.
• Introduce new technology to enhance workflow and capabilities.
• Manage development and characterization laboratories, troubleshooting of methods, instrumentation, and equipment to ensure timely in-house testing to support client programs. 

• Build and staff a functional organization.  Have a clear understanding of modern protein analytical techniques, microbial and cell culture processes as well as protein recovery operations. Make and review scientific risk assessments of operational discrepancies and reach logical conclusions. 
• Work synergistically with the manufacturing and process sciences functions at Avid and demonstrate the qualities of high integrity and rational decision making. Have a solid background in the ICH guidance documents as well as assay and process validation.
• Be highly persuasive and yet capable of viewing the bigger context of a problem and able to work through issues in a collaborative environment.
• Be highly experienced in handling Global Regulatory authority inspections with a proven track record of successful inspections. 
• Listen carefully to questions that are asked and respond clearly and concisely.  Provide strategic direction during inspections and/or audits to ensure a successful outcome. Responsible for addressing corporate responses to audit or inspection results.
• Manage/direct the selection, training, motivation, development, appraisal and work assignments of QC personnel.
• Other projects may be assigned by executive management. 

• B.S. in Microbiology, Chemistry or related science.
• At least 10 years of quality experience in pharmaceutical and/or biologics industry.
• 4+ years’ experience supervising/managing QC functions in a cGMP environment.
• Knowledge of CGMPs, 21CFR210-211, ISO 14644, Federal Std 209-E.
• Experience in the following: writing and executing IQ, OQ, PQ, Regulatory Compliance, and Inspection. 
• Knowledge of FDA guidelines, USP, EP, EU Annexes, and ICH guidelines. 

• You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
• Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
• You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
• You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.