- Develop and perform assays that support development, release and stability testing of pharmaceutical drug substance and drug products.
- Documents laboratory work in accordance with GxP expectations, company policy, and legal requirements.
- Review of experiments, stability protocols and other key documentation.
- Contribute to sections of patents or regulatory submissions as well as internal reports.
- Identifies and troubleshoots any problems in the execution of experimental processes; interprets results and communicates them to his/her supervisor.
- Provides scientific input and recommendations to the project team for analytical control strategies and influence decision making.
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- Experience with method development & validation, pharmacopeia compliance and analytical lifecycle management.
- Experience working with several analytical techniques, and laboratory procedures.
- Experience in interpreting and communicate experimental data.
- Knowledge of cGMP requirements
- Experience with analytical support of challenging long acting injectable, parenteral and sterile formulations.
- Experience with analysis of active pharmaceutical ingredients (API) and their process development.
- Awareness with FDA/EU/UK and ICH regulations and guidances related to analytical transfer and validation and release and stability testing.
- Working knowledge and experience in small molecule analytical techniques such as HPLC, UPLC, GC, dissolution, UV/Vis spectrophotometry, KF, MS, and laboratory procedures.
- Good technical writing skills for documentation. Experience in regulatory documentation authoring.
- Ability to collaborate and communicate well with others in and across groups in matrix.
- Thorough operational knowledge of laboratory equipment and laboratory systems (e.g. Waters Empower CDS and Electronic Notebook system).
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Senior Scientist - Collegeville, United States - GlaxoSmithKline
Description
Site Name: USA - Pennsylvania - Upper ProvidencePosted Date: May 8 2024
Are you seeking an opportunity where you can help deliver life changing medicines and devices while you can grow your technical expertise on pharmaceutical analysis and development? If so, this Senior Analytical Scientist role is an exciting prospect to explore. At GSK we aim to positively impact the health of 2.5 billion people over the next 10 years.
As a Senior Scientist in the Analytical Development department, you will design and perform experiments to develop, validate and transfer various analytical methods. You will be involved in all aspects of pharmaceutical development, including engagement with project teams and other stakeholders for projects in different stages of development.
This role will provide YOU the opportunity to contribute to analytical development and to progress YOUR career. Your responsibilities include some of the following:
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
#LI-GSK
Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or 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.
