Sr. Biopharmaceutical Associate
Performs production operations including fermentation or cell culture operations, preparation of media and buffer solutions, chromatographic separation, filtration and concentration operation, etc as well as being involved in both start-up and product changeover activities. Will be responsible for completing daily manufacturing tasks as well as supporting more in-depth, long term projects.
- Completing daily manufacturing tasks per standard operating procedures and batch document instructions.
- Monitors critical process parameters
- Documenting all manufacturing activities clearly and accurately.
- Monitor and audit work processes to ensure compliance and completion of goals.
- Trains new and less experience team members.
- Actively participates in the creation and revision of Batch Records, Standard Operating Procedures and other GMP documents.
- Assist with closure of process deviations, investigations and corrective actions.
- Maintains a high level of mechanical and technical aptitude and training.
- Assist resolution of technical and process problems; Identify, develop and implement process improvements
- Works on problems of advanced scope where analysis of situation or data requires a review of identifiable factors, including process history.
- Identify process issues' collaborate with team and external dept. to address best practices.
- During technical transfer and the start up activities, provide input on design and operation of equipment.
- Ensures all production activities are completed in a safe and compliant manner.
- Leads the production teams as required in the absence of senior staff.
- Maintain at least 85% cGMP training to ensure compliance.
- Perform CIP and SIP or product tanks
- Dispense large and small amounts of raw materials.
- Will work with some hazardous materials under the appropriate safety procedures
- Receive, stage and track materials
- Maintain at least an 95% cGMP training proficiency to ensure compliance
BS/BA or Associates Degree with 2-6 or more of directly related experience. Degree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience.
- 3-6 years prior manufacturing experience in the pharmaceutical or biotechnology industry, with the demonstration of a high level of performance.
- understanding of the basic FDA cGMP regulations
- Strong verbal and written skills. Must be able to follow detailed processing instructions as well as accurately document all necessary paperwork.
- Demonstrated ability to work effectively as a team
- Ability to work a shift that covers a 24/7 operation.
- Downstream experience greatly preferred.
You may apply for this position online by selecting the Apply now button.
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