Biopharmaceutical Manufacturing Associate II
Site Name: USA - Maryland - Rockville
Posted Date: Apr 9 2019
• As Biopharmaceutical Manufacturing Associate you will be responsible for...
Under the direction of senior personnel, performs production operations including cell culture operations, preparation of media and buffer solutions, centrifugation and filtration operation, etc as well as being involved in both start-up and product changeover activities.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
• Completing daily manufacturing tasks per standard operating procedures and batch document instructions.
• Monitors critical process parameters
• Documenting all manufacturing activities clearly and accurately.
• Ensures all processing equipment and materials necessary are adequate and available to set the team up for success.
• Ensures all production activities are completed in a safe and compliant manor.
• Maintain and prepare high quality documentation.
• Dispense large and small amounts of raw materials
• Perform CIP and SIP of product tanks
• Work with hazardous materials under the appropriate safety procedures
• Performs other functions as necessary or as assigned.
• Maintain at least an 95% cGMP training proficiency to ensure compliance
We are looking for professionals with these required skills to achieve our goals:
BS/BA or Associates Degree with 6 months 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.
v 6 months or greater manufacturing experience in Large Scale Mammalian downstream, with the demonstration of a high level of performance
v Understanding of the basic FDA cGMP regulations
Ø Small Scale Downstream Experience with knowledge on the following:
Ø Viral Inactivation
Ø Viral Filtration
Ø Aseptic Hood Operations
v Knowledage of using MERP
v Strong team player with strong verbal and written communication skills
If you have the following characteristics, it would be a plus:
• Strong verbal and written skills.
• Must be able to follow detailed processing instructions as well as accurately documenting all necessary documentation.
• Ability to work shift that covers a 24/7 operation
• Ability to lift and carry materials weighing as much as 50lbs.
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
• Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being
• Building strong relationships and collaboration, honest and open conversations.
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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