Job Description

Position SummaryThe position will work in the Strategic External Development (SED) department within GSK R&D. SED is an externally focused CMC organization accountable to deliver CMC activities through GSK\xe2\x80\x99s network of trusted external partners whilst remaining closely connected with GSK\xe2\x80\x99s internal technical teams.The Senior/Lead Scientist, Quality Control is responsible for the day-to-day oversight of analytical testing at contract laboratories and contract manufacturing facilities for testing of various clinical phase GSK assets spanning modalities such as large molecules including ADCs, small molecules and oligonucleotides. The individual will interact with internal multidisciplinary teams and the third-party testing laboratories to ensure successful delivery schedules of analytical test reports or certificates. This includes assisting with QC checks and preparation of regulatory filings (INDs and NDAs).ResponsibilitiesAssist in drug substance and drug product analytical testing at contract laboratories.Assist in stability activities including data review and trend evaluation and writing of timely stability reports.Review QC raw data and assist in batch release.Monitor contract laboratory activities to ensure compliance and timeliness of certificates of approval and reports.Summarize and report laboratory performance metrics.Assemble data packages in support of specification and method changes.Assist in the preparation of the analytical sections of regulatory filings (Supplements and Annual Reports).Provide analytical support for manufacturing investigations as required.Maintain current knowledge of all relevant USP/NF and EP requirements and FDA/EU guidance.Other duties as assigned.Candidates with additional experience will alsoRepresent QC in cross-functional teams with internal and external customers.Review and approve various quality documents (internal and external).Contribute to the investigation and resolution in analytical test failures (OOS and atypical results).Participate in vendor and internal audits as needed.Contribute to company quality systems.Job RequirementsBSc/MSc in a relevant scientific area.4 to
6+ years\xe2\x80\x99 experience in the pharmaceutical/biopharm manufacturing industry. The final grade/job title offered will be commensurate with the candidate\xe2\x80\x99s experience.Knowledge of analytical testing concepts and current cGMPs including laboratory controls and good documentation practicesThe role holder will have experience in the analysis of one or both of oligonucleotide therapeutics and/or antibody drug conjugates, however candidates with experience in the QC testing of recombinant protein therapeutics will also be considered.Proven ability to work with cross-functional teams comprised of internal and/or external contact facilities.Experience building relationships and working with CDMOs.Working knowledge ICH quality guidance, EU and FDA drug manufacturing regulations.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.Ability to travel internationally 10%.This is a hybrid role with a minimum expectation of 2 to 3 days working at a GSK office.To learn more about Singapore GSK and our people, please click on this link:#Li-GSKWhy GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 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\xe2\x80\x99s 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 \xe2\x80\x93 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.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.

GlaxoSmithKline