Manufacturing is a key strength at Biogen Idec. The company's capabilities and capacity for protein manufacturing are world class in quality and scale.
The manufacturing team is responsible for the last leg of a long journey. This journey is difficult, expensive and can take well over a decade. The process begins in research and development and is ultimately transferred to Manufacturing, but Manufacturing is also involved at the development stage to ensure we can produce what we create.
Prior to product approval, our goal is to produce quality material to supply clinical trials. Once a product is approved by regulatory agencies, our job is to generate material to commercially supply patients across the globe.
The Manufacturing Associate performs and documents daily manufacturing operations in a cGMP environment that involves operation of process equipment, execution of validation protocols, creating/revising cGMP documents, and other assignments. The person is highly detail oriented with excellent documentation skills and good troubleshooting abilities. The Manufacturing Associate is skilled in the operation of all unit operations in their area, and (at level IV and above) is typically an area expert on at least one unit operation, and often leads others in the execution of manufacturing processes.
1. Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record, SLR and control system. Coordinates and/or leads process steps as required.
2. Documents/Records and Reviews cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures. Revises and/or creates documents as instructed. Key documentation includes batch records, SLRs, and equipment logbooks.
3. Investigations deviations, develops and implements corrective and preventative actions as required by supervisor.
4. Actively participates in training activities, managing their individual training plan. Trains other associates as required.
5. Executes validation protocols with minimal supervision/direction of others. Location US-NC-Research Triangle Park Job Category Biopharmaceutical Sciences (MFG) Requisition Number 19097BR Qualifications Process Knowledge:
- Possesses strong technical understanding of equipment and procedures, and identifies potential process and equipment improvements. Understands the theory and concepts behind the process, including an understanding of the impact of own area on upstream and downstream activities.
- Knowledgeable on non-routine process occurrences. Recognizes potential process and equipment problems. Understands implications of test/process specifications, operating ranges, alert and action limits.
- Writes new and edits existing SOPs.
- Understands basic biotechnology processing – purpose of major unit operations and microbial control concepts.
- Anticipates potential problems and takes preventive action in consultation with supervisor.
- Recognizes non-routine problems, investigates and suggests potential solutions.
- Makes routine decisions based on experience. Identifies and suggests solutions to common, basic problems.
- Recognizes obvious problems and alerts supervision.
Must be able to work day OR night shift (6am-6pm) rotation (includes every other weekend). Education Minimum Requirements:
- Effectively communicates concepts and ideas, in addition to facts, both with-in the department as well as cross-functionally.
- Strong oral and written and skills. Capable of writing basic reports and summaries.
- Good written communication skills. Clearly communicates process information and process issues with co-workers and supervision, and communicates in a timely manner.
The level of this role will be determined by the overall qualifications of the candidate selected (i.e., Manufacturing Associate II, III, IV or V).
- BA or BS with 0-5 years direct/related experience, or
- AA or AS with 1-7 years direct/related experience, or
- Certificate (i.e., Bioworks) with 3-9 years direct/related experience, or
- High School Diploma with 5-10 years direct/related experience
Biogen Idec - 2 years ago
Biogen Idec (NASDAQ: BIIB) is a global leader in the discovery, development and delivery of innovative therapies to improve the lives of...