Manager, CMC Quality Control

Glaxosmithkline Collegeville , PA 19426

Posted 2 months ago

We are building a state-of-the-art end to end Biopharm capability which delivers efficient discovery of antibody molecules that are selected and engineered for rapid development so that, together with our therapy area partners, we discover, develop and manufacture novel portfolio of exciting medicines to benefit patients around the world. If you aim to be part of a global cutting edge drug development and discovery organization and are motivated to contribute towards bringing lifesaving drugs to patients, join us!

Click to know more about GSK Biopharm.

#GSKBiopharm_Development

The Manager Quality Control is responsible for 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 includes assisting with QC checks and preparation of regulatory filings (IND, BLA and NDA), and manage projects associated with drug substance and products.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

  • 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.

  • Investigate and resolve analytical test failures (OOS and atypical results)

  • Monitor contract laboratory activities to ensure compliance and timeliness of certificates of approval and reports

  • Review QC raw data and assist in batch release.

  • Assemble data packages in support of specification and method changes associated with GSK products

  • Represent QC in cross-functional teams with internal and external customers

  • Assist in the preparation of the analytical sections of regulatory filings (Supplements, and Annual Reports)

  • Review and approve various quality documents (internal and external) associated with GSK products

  • Provide analytical support for manufacturing investigations as required

  • Participate in vendor and internal audits as needed

  • Contribute to company quality systems

  • Maintain current knowledge of all relevant USP/NF and EP requirements and FDA/EU guidances.

  • Other duties as assigned

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • BS in a scientific area

  • 5+ years' experience in the pharmaceutical/bio-pharm manufacturing industry with at least 1 of those years at the QC manager level

  • Experience with analytical testing concepts and current cGMPs including laboratory controls and good documentation practices

  • Experience building relationships and working with CMOs

  • Ability to travel (includes international), 10%

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts

  • 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

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.

  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

  • Continuously looking for opportunities to learn, build skills and share learning.

  • Sustaining energy and well-being.

  • Building strong relationships and collaboration, honest and open conversations.

  • Budgeting and cost-consciousness.

  • LI-GSK

gskbiopharm_development

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.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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.

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Manager, CMC Quality Control

Glaxosmithkline