Lead Biopharm Manufacturing Associate
Site Name: USA - Maryland - Rockville
Posted Date: Apr 3 2019
As Lead Biopham Manufacturing Associate you will be perform 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 biopharm manufacturing tasks as well as supporting more in-depth, long term projects, Operation of Bioprocess Equipment under strict adherence to and enforce cGMP, OSHA and polices and regulations, or others as required.
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.
• Trains new and less experienced team members.
• Conduct relevant process, cGMP and safety training
• Effectively troubleshoot production equipment and processing problems of varying scope
• Actively participates in the creation and revision of Batch Records, Work Instructions, Standard
• Operating Procedures and other GMP documents.
• Maintains a high level of mechanical and technical aptitude and training.
• 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.
• Provide information to the supervisor on performance of the team.
• Coach, facilitate, solve work problems and participate in the work of the team.
• Communicate assignments, milestones and deadlines to the team and individuals based on supervisor's
• Observe training needs and relay training needs and requests to supervisor and the team.
• Identify and relay request for resources and supplies to supervisor and procures as necessary.
• Lead the production team as required in the absence of supervisor.
• Lead resolution of technical and process problems, initiate change control for equipment/process
• Lead closure of process deviations, investigations, corrective/preventive actions, and maintenance work
• Lead new production projects, develop commissioning plans and author commissioning documents
• Member/Lead of project teams for technical transfer or new product scale-up
• Work on problems of advanced scope, potentially cross-functional, where analysis of situation or data
• requires a review of identifiable and unknown factors
• Identify, develop and implement process improvements, equipment improvements/upgrades
• Monitor and audit work processes to ensure compliance and completion of targets
• Will work with some hazardous materials under the appropriate safety procedures
• Order, receive, stage and track materials
• In conjunction with Supervisor, ensure completion of daily operations
• Maintain cGMP training proficiency to ensure compliance
We are looking for professionals with these required skills to achieve our goals:
3-5 years directly related manufacturing experience in the pharmaceutical or biotechnology industry, with the demonstration of a high level of performance
Understanding of the basic FDA cGMP regulations
BS/BA or Associates Degree in biological sciences, chemical sciences, engineering or equivalent technical discipline. Degree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience.
Ability to work a shift that covers a 24/7 operation
If you have the following characteristics, it would be a plus:
® Demonstrated ability to work effectively in a team, lead teams and implement project plans on time and on budget, s Strong verbal and written skills.
® Must be able to follow detailed processing instructions as well as accurately documenting all necessary
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.
Budgeting and cost-consciousness
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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