Biological Operations Coordinator

4 days ago


Étreux, Hauts-de-France, United States BioSpace, Inc. Full time
Job Overview

BioSpace, Inc. is a leading company in the biotechnology industry, and we are seeking a skilled Biological Operations Coordinator to join our team. As a key member of our manufacturing department, you will be responsible for ensuring the smooth operation of our biological production facility. This role requires strong organizational skills, attention to detail, and excellent communication abilities.

About the Role

The Biological Operations Coordinator will work closely with maintenance, engineers, and other support personnel to perform functions associated with current Good Manufacturing Practices (cGMP) manufacturing operations. You will use sophisticated programs such as Maximo, Cognos, and SAP to manage project changeovers, schedule work orders, and provide purchasing support for plantwide materials. Additionally, you will support planned interruptions to routine production process schedules and activities, including providing expertise for controlling and justifying no potential product impact.

Key Responsibilities

- Manage project changeovers, including drafting changeover schedules and records, and coordinating activities for successful on-time next project releases.
- Initiate and schedule work orders, both routine frequency maintenance and on-demand requests, to ensure on-time completions or rescheduling and/or justifying extensions as needed.
- Provide purchasing support for plantwide materials, including carts, pumps, benchtop meters, etc.
- Support planned interruptions to routine production process schedules and activities, including providing expertise for controlling and justifying no potential product impact.
- Transfer methods into Production instructions to allow for successful performance of scheduled campaigns.
- Schedule work tasks, with general assistance, to support project and campaign timelines. Draft moderate scope and complexity documents, circulate them to reviewers with general assistance, respond to comments and questions, and manage document review and approval to meet project timelines and provide status reports to management.
- Work with management and senior staff to determine appropriate course of action within defined procedures. Track ongoing problems and gather information for analysis. Analyze data to develop solutions to moderate-level problems.
- Apply knowledge, experience, and technical skills to understand ABC production objectives, provide support to production initiatives, execute procedures efficiently and compliantly, and use standard practices to ensure inter-group consistency.

Qualifications

To be successful in this role, you will need a Bachelor's Degree or equivalent and at least 2-5 years of relevant experience with good writing skills. You must have working knowledge of media/buffer preparation, cell culture, or purification of biological drugs, computer proficiency, and a working knowledge of safety, quality systems, and cGMP. Familiarity with tech transfer processes is also required.

Estimated Salary Range

We offer an estimated salary range of $65,000 - $85,000 per year, depending on your level of experience and qualifications. In addition to a competitive salary, we offer a comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and 401(k) eligibility. This job is eligible to participate in our short-term incentive programs.

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