Lead Biopharmaceutical Manufacturing Associate

Lead Biopharmaceutical Manufacturing Associate
+ Requisition ID:WD92117
+ Position:Full time
+ Open date:Sep 29, 2016 9:23 PM
+ Functional area:Manufacturing
+ Location:Maryland
+ + Required degrees:Bachelors
+ Experience required:3 years
+ Relocation:No
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Basic qualifications:BS/BA with 3 - 5 years 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 - 5 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:Demonstrated ability to work effectively in a team, lead teams and implement project plans on time and on budget.
Strong verbal and written skills.
Must be able to follow detailed processing instructions as well as accurately documenting all necessary documentation.
Ability to work a shift that covers a 24/7 operation
Ability to lift and carry materials weighing as much as 50lbs.
Details:Why GSK? Because GSK?s Biopharm business vision is to leverage its experience and technical capabilities to launch, supply, and manage Biopharmaceutical products around the world. It will fulfill GSK?s Mission to Do More, Feel Better, and Live Longer by living its values: Integrity: Always doing the right thing; Commitment to the Patient: Making the Patient the #1 Priority; Customer Service: Commit to delivering on promises to internal & external customers; Compliance ? Being accountable for quality and safety.
GSK Biopharm in Rockville MD has an opening for a Lead Biopharm Manufacturing Associate. In this role, you will 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. You will be responsible for completing daily manufacturing tasks as well as supporting more in-depth, long term projects.
Key Responsibilities
Operation of Bioprocess Equipment under strict adherence to and enforce cGMP, OSHA and polices and regulations, or others as required.
Completing daily manufacturing tasks per standard operating procedures and batch document instructions.
Ability to perform the following operations: CIP, SIP, SOP, cGMP, Tangential, Aseptic technique, Centrifugation, Harvest Processing, Filter integrity testing.
Monitors critical process parameters
Draft and revise SOPs and Batch Records as necessary
Documenting all manufacturing activities clearly and accurately.
Trains new and less experienced team members.
Conduct relevant process, cGMP and safety training
Effectively troubleshoot equipment and processing problems
Actively participates in the creation and revision of Batch Records, 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 manor.
Provide information to the supervisor on performance of the team.
Coach, facilitate, solve work problems and participate in the work of the team.
Provide information to the supervisor on performance of the team.
Communicate assignments, milestones and deadlines to the team and individuals based on supervisor?s instructions.
Observe training needs and relay training needs and requests to supervisor.
Relay request for resources and supplies.
Leads the production team as required in the absence of supervisor.
Lead resolution of technical and process problems, initiate change control for equipment/process modifications
Lead closure of process deviations, investigations and corrective actions
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 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
Dispense large and small amounts of raw materials
Perform CIP and SIP of product tanks
Will work with some hazardous materials under the appropriate safety procedures
Receive, stage and track materials
In conjunction with Supervisor, insure completion of daily operations
Maintain at least an 95% cGMP training proficiency to ensure compliance
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.
Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK?s compliance to all federal and state US Transparency requirements. For more information, please visit GSK?s Transparency ReportingFor the Recordsite. af58ac166ec34452958b298885821c5a

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