Bioprocess Engineer / Senior Technology Associate
- Rockville, MD
Site Name: USA - Maryland - Rockville
Posted Date: Aug 10 2020
- Determine adequacy of plant to accept new technologies and appropriate actions to implement start of new process operations.
- Responsible for development and preparation of technology transfer/process validation protocols and "hands-on" startup of production processes with operators.
- Responsible for preparation and presentation of technology transfer/process validation reports or documentation.
- Define training program for operators as part of technology transfer and when required train process operators.
- Identify potential process problems, provide technical advice to Production and/or Quality Department to resolve process problems.
- Advise management as to possible opportunities for process improvements.
- Collect and track process trend data and monitor process trends.
- Determine causes of process variances and recommend corrective actions.
- Stay current with developments in the fields of biotechnology and bioprocessing.
- Responsible for learning and understanding process technologies under development within R&D.
- Demonstrate the use of OE tools and philosophies.
- As necessary will be required to carry out laboratory based biopharmaceutical process development/investigational activities.
- Independently design basic lab experiments and interpret data/results with minimal supervision.
- BS/BA in either biological or chemical science or engineering or equivalent technical discipline.
- A minimum of 3 years post-graduate experience in the Biopharmaceutical/ pharmaceutical industry or equivalent.
- Knowledge of current GMP's, ICH Guidelines and FDA and/or European validation practices for biopharmaceutical processes required.
- Preferably has at least 1 year of experience in the development of biopharmaceutical drug substance manufacturing processes.
- Knowledge in biopharmaceutical technologies such as large scale cell culture/microbial technology, biopseparations technologies, or pharmaceutical manufacturing of proteins.
- Basic understanding of analytical technologies related to the above.
- Strong interpersonal and leadership skills.
- Strong verbal and written communication skills.
- Strong Analytical and critical thinking skills.
- Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines.
- Able to prioritize, and decide appropriate courses of actions.
- Effective at implementing decisions.
- Committed team player prepared to work in and embrace a team-based culture.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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/ Agencies
GSK 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 Reporting For the Record site.
Back to top