Zebulon, North Carolina, USA
19 days ago
Small Molecule Technical Manager
Site Name: USA - North Carolina - Zebulon Posted Date: Apr 8 2024 The Small Molecule Technical Manager is responsible for all technical activities occurring at aligned CMOs (contract manufacturing organizations) managed by External Supply. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Supporting ongoing product supply from CMO network by ensuring robust and capable processes are in place and monitored. Technical oversight and trouble shooting support for ongoing manufacture, packaging and supply of product from third party contractors, linking in the necessary packaging support from MSAT / APS group as required. Technical process support for the introduction of New Products into new or existing Contract Manufacturing Organizations to ensure that they meet GSK requirements, are capable and robust, through close liaison and collaboration with R&D. Support of product transfers from GSK sites to a Contract Manufacturing Organization, between Contract Manufacturing Organizations or from Contract Manufacturing Organizations to GSK sites, resulting from product / dose form source plans and strategic reviews. Owner of repository of knowledge and knowledge transfer associated with new and transferred products. Impact assessment and support of the process changes (GSK or Contract Manufacturing Organization driven) related to active materials, excipients, primary and secondary packaging materials incl. risk assessment. Ensure with Quality Assurance (ESQ) that necessary validation activities are planned, executed and maintained to current standards of Product Lifecycle Management in line with GSK QMS by Contract Manufacturing Organizations through the lifecycle of the product. Ensure that technical compliance gaps in manufacturing and packaging at Contract Manufacturing Organizations are highlighted and plans are developed to close the gaps. Technical project support related to all manufacturing/packaging related projects at Contract Manufacturing Organizations. Applying OE tools and principals in the implementation of technical projects and improvement initiatives. Support Due diligence activities by providing technical review and assessment of potential new products / CMO’s Supporting 20 to 30 technical projects or a smaller number of High value and business critical projects at Contract Manufacturers. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree 10 years Manufacturing experience in pharmaceuticals - solid dose products or liquid creams/ointments Preferred Qualifications: If you have the following characteristics, it would be a plus: Technically competent Experience in managing external 3rd parties Experience solving technical problems and troubleshooting technical issues Experience with technical transfer of products from one site to another #LI-GSK Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why Us? 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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. 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.
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