Sr. Biopharmaceutical Associate

Your Responsibilities:
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

Why You?

Basic qualifications:
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

Preferred qualifications:
- 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.

Why GSK?:

Contact information:
You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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