Scientist, Upstream Process Development- Technical Development Drug Substance

Scientist, Upstream Process Development- Technical Development Drug Substance
+ Requisition ID:WD88494
+ Position:Full time
+ Open date:Sep 22, 2016 3:04 PM
+ Functional area:Science and Technology
+ Location:Maryland
+ + Required degrees:Bachelors
+ Experience required:3 years
+ Relocation:Not Indicated
Email a friend
Basic qualifications:? BS with 6+ or MS with 3+ years or PhD with 1+ years of experience
? Degree must be in a scientific discipline
? Hands-on and in-depth understanding of mammalian cell culture and cellular metabolism
? Hands-on experience with on-line and off-line analysis instruments associated with cell culture and viral vector production processes
? Basic experience with common bioanalytical assay execution
? Hands-on expertise in bioreactor system operation including AMBR, and wave and stirred tank bioreactors is essential
? Knowledge of industry trends and advancements is essential as well the ability to lead novel technology implementation
? Ability to plan and execute experiments and analyze resulting data using appropriate software
?Excellent verbal and written communication skills
Preferred qualifications:? Knowledge of equipment and procedures relating to upstream process development for the manufacture of vaccines. This includes a strong understanding of scale-up of bioreactors, multiphase mixing models, and mass transfer
?Additional hands-on experience and understanding of single use bioreactor (SUB) systems at pilot scale is desirable
? Knowledge of technology transfer to manufacturing plants is desirable
? Working knowledge of Quality by Design (QbD) and Design of Experiments (DoE) and statistical software such as Design Expert or JMP would be an advantage
? Good understanding of cGMP and manufacturing, and regulatory requirements for filing and registration of vaccine and/or biologics
? Ability to plan and execute experiments and to analyze and draw conclusions from resulting data
? Excellent verbal and written communication skills; and a demonstrated ability to work as part of a project team
Details:The employee is part of upstream process development team responsible for the development of early and late phase processes for the production of vaccines; performing cell culture development activities for recombinant vaccine antigens or viruses used for clinical and commercial development of vaccine candidate manufacturing processes; providing assistance in the execution of analytical methods in support of purification development for viral vaccines.
Major accountabilities include the followings:
? Performs upstream activities in support of viral vaccine development programs
? Must be able execute experiments independently
? Understanding of scale-up techniques and the ability to contribute to tech transfer to manufacturing will be essential
? Contributes to the transfer, evaluation and optimization of analytical assays used for in-process testing and characterization
? Contributes to regulatory filings and interactions with health authorities to ensure successful registration vaccine candidates
? Works on multiple projects internally, at other sites and at external manufacturers requiring initiative and judgment
? The qualified candidate must be able to effectively partner with diverse team members from various functions, multiple countries and members at various levels in organization
? Must be a self-starter, be able to work with minimal supervision in a matrix environment and effectively manage multiple projects
? Solves complex problems through analytical thinking to identify and understand alternatives using knowledge gained through formal education, experience and sound judgment
?Summarizes results in written reports and oral presentations
?Provides guidance and mentorship to less experienced colleagues and acts as a technical advisor
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.
US - Rockville Video - Rip 492d638641464877ae378b923f808e8c

Don't Be Fooled

The fraudster will send a check to the victim who has accepted a job. The check can be for multiple reasons such as signing bonus, supplies, etc. The victim will be instructed to deposit the check and use the money for any of these reasons and then instructed to send the remaining funds to the fraudster. The check will bounce and the victim is left responsible.

More Jobs

Sr. Scientist Upstream Process Development
Rockville, MD ABL, Inc
Scientist - Downstream Process Development
Annapolis, MD GlaxoSmithKline
Scientist, Drug Substance, Expression Technology
Annapolis, MD GlaxoSmithKline
Scientist II, Biochem/Cell/Media Development
Frederick, MD Thermo Fisher Scientific Inc.
Upstream Process Scientist
Baltimore, MD Lab Support, a division of On Assignment