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Senior Scientist

3 months ago

Waltham, Massachusetts, United States GlaxoSmithKline Full time
Site Name: USA - Massachusetts - Waltham, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence
Posted Date: Jul

The Senior Scientist Quality Control is responsible for contribution to the day-to-day oversight of analytical testing at contract laboratories and contract manufacturing facilities for testing of development pharmaceutical products and Active Pharmaceutical Ingredients (API) in support of GSK's small molecule and/or immuno-oncology programs. The individual will interact with internal multidisciplinary teams to ensure successful delivery schedules of analytical test reports or certificates. This position includes assisting with internal Quality processes, QC checks, and preparation of regulatory filings (IND, BLA and NDA), and assist in managing projects associated with drug substance and products.

Specific Accountabilities:
  • Prepare and review various quality documents (internal and external) associated with GSK products
  • Coordinate activities related to company quality systems
  • Assist in the management of drug substance and drug product analytical testing at contract laboratories
  • Assist in the management of stability activities including data review and trend evaluation
  • Review QC raw data and assist in batch release process
  • Assemble data packages in support of specification and method changes associated with GSK products
  • Represent QC in cross-functional internal teams
  • Assist in the preparation of the analytical sections of regulatory filings (Supplements, and Annual Reports) including the verification of data
  • Maintain current knowledge of all relevant USP/NF and EP requirements and FDA/EU guidance
  • Other duties as assigned


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's degree in chemistry, biology, biochemistry, pharmacology, immunology, or closely related field
  • 2 years minimum with preferred 3+ years' experience in the pharmaceutical/bio-pharm manufacturing industry
  • Experience with analytical testing concepts, stability testing and current cGMPs including laboratory controls and good documentation practices


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Experience building relationships and working with internal project teams
  • Ability to manage tasks and work with cross-functional teams comprised of internal and/or external contacts
  • Working knowledge ICH quality guidance, EU and FDA drug manufacturing regulations
  • Demonstrated proficiency with Quality System Records, Deviations, Change Controls and CAPAs
  • Excellent written and oral communication skills
  • Competency in MS Office Products and Adobe Acrobat
  • Independently motivated and detail oriented with good problem-solving ability
  • Ability to work a flexible work schedule to accommodate program priorities and international activities as needed

#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

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