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Manufacture Planning Coordinator

King of Prussia, Pennsylvania
Closing date
Dec 2, 2021

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Pharmaceutical, Supply Chain, Quality Assurance
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Site Name: USA - Pennsylvania - King of Prussia Posted Date: Oct 28 2021 The Manufacture Planning Coordinator is responsible for secondary manufacturing and testing for biopharmaceutical drug product, supporting safety assessment studies and clinical trials for early and late stage assets. The Manufacture Planning Coordinator will facilitate activities between process development, GMP Operations, and sterile filling sites. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Coordinate planning for secondary manufacturing and testing for biopharmaceutical drug product as required supporting safety assessment studies and clinical trials for early and late stage assets. Coordinates activities between process development, GMP Operations, and sterile filling sites. Serves as supporting member to the project team. Executes planning and logistics for secondary manufacture, testing, shipments, storage, and release activities across internal/external sites. And has the ability to track product inventory in material management systems. Align to standard work across all aspects of operational planning (including customer service, order fulfilment and supply chain planning) within the planning team. Manage and support logistical shipping of material for domestic and international activities. Work in alignment with Biopharm Process Sciences, Analytical scientists, and manufacturing sites in oversight and implementation of appropriate technologies. Collect data, analyze results fully and recommend follow-up actions. Support process improvements to the supply chain cycle time. Ensure documentation is sufficient to support consistent production and regulatory filings. Prepares, reviews, and/or approves documents for use in manufacturing and planning. May also prepare campaign summaries and documents for validation and regulatory purposes. Coordinate Secondary Manufacturing operations planning for BPDS clinical supplies for the early and late stage assets in the portfolio. This role will support the process release of Tox, Reference Standard and Clinical material, completion of logistical/documentation aspects of shipping requirements. Support the BioPPD/MPD/Product Teams and the filling schedule of Biopharm operations across multiple filling locations (both domestic and international). Responsible for facilitating the manufacture planning meetings for the assets responsible for managing Accountable for reporting and maintaining metrics Initiate and own aspects of change management for revisions to specifications and filling sites as required. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS in relevant field with 3+ years' experience in manufacturing operations Knowledgeable in cGMP, especially documentation, process, and validation. Knowledgeable about Material Management Systems, Microsoft One Note, and Excel. Experience in continuous improvement projects and/or activities. Ability to develop and present detailed planning and order fulfilment scenarios. Ability to use Lean Sigma and Root Cause Analysis methodologies for process improvement. Ability to assimilate information from different sources to foresee and proactively prevent issues. Knowledgeable about material management techniques and planning processes. Preferred Qualifications: If you have the following characteristics, it would be a plus: Time management and prioritization skills. Attention to detail and ability to work under pressure. Excellent numeracy and communication skills both written and verbal, including basic presentation skills. Excellent organizational and teamwork skills 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 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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