Job Details

Bionova Scientific LLC

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems.

Because our success depends on our ability to exceed our clients' expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team.

Position Summary

This position will be responsible for all aspects of laboratory controls including the administration of QC specific IT systems. This activity includes administration of master data in the LIMS system, user administration for all lab specific IT systems, design and implementation of LIMS workflows, controlled issuance of documents such as laboratory test records. It also includes general laboratory activities such as administration of releases samples, inventory control and tracking and implementation of lean and IT supported lab processes in QC.

This position will provide a high level of independent judgment and discretion in the timely identification, investigation, and resolution of issues impacting the Quality Control department related to sample management. Taking over the lead in implementing continuous improvement efforts as it relates to Quality Control activities.

Essential Duties and Responsibilities

• Administrate LIMS system, update Master Data for release and stability testing.
• Take over lead in implementation of new workflows in the LIMS improving lab efficiency and compliance.
• Be the lead in suggesting IT solutions to support lean and efficient processes within QC and the interface to other departments.
• Have oversight over sample inventory
• Present sample management processes and IT systems in internal/corporate client audits and health authority inspections.
• Responsible aliquoting and distributing samples for the appropriate QC tests.
• Key point of contact when working with internal and external partners (MFG, QA, external labs and clients)
• QC SME for IT aspects of Data Integrity initiatives
• Lead cross-functional investigations or assessments in support of change controls, CAPA/investigations, or other compliance activities as it relates to QC IT systems or sample management activities. Define appropriate corrective actions as necessary.
• Manage complex projects.

Working Conditions

• This position is required to work in a lab setting.

Qualifications

• Bachelor's Degree from an accredited institution in Chemistry, or Biology (or closely related degree).
• Strong IT background.
• Requires 2-5 years of pharmaceutical or medical device experience.
• Experience with pharmaceutical IT systems (e.g. LIMS, eBR, Enterprise Management Systems (EMS), or Enterprise Resource Planning Systems (ERP))
• Strong independent judgment and decision-making abilities and strong conflict resolution required.
• Knowledge and experience with 21 CFR Part 11 and Annex 11 compliance.
• Participates in Data Integrity and continuous improvement initiatives.
• Participates or experience leading projects with history of achieving results.
• Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little supervision.
• Ability to make independent sound decisions and manage priorities in alignment with department and site drivers.

Compensation Range: The base compensation range for this role is between $85,000 and $100,000. However, the actual compensation may vary depending on your experience and qualifications.

Bionova offers health benefits at a subsidized rate.

Healthcare, Dental, and Vision insurance

Life Insurance and Disability Program: 100% covered by Bionova.

Retirement Plan (401K) Up to 8% of Employer Match

Paid time off up to two weeks

10 days of Holidays and 5 days of Sick Leave.

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.