Are you seeking an opportunity to leverage your expertise to - - work with and influence external (Contract Manufacturing Organizations) and internal supply base to deliver the strategy; apply your scientific knowledge to trouble shoot sterile product manufacturing/processing issues; maintain the product robustness throughout the life cycle and meet the demands of the Pharma supply chain to provide quality product to the patient? If yes, our Technical Manager opportunity may be the right position for you to explore.
External Supply Pharma Technical is a key support function to External Supply Pharma and Business Development which is part of Pharma Supply Chain and is responsible for the management of Rx CMO’s (contract manufacturing organizations) Globally. (Approximately 80 CMO’s Globally).
Under the direction of a Technical Director, the Technical Manager is responsible and accountable for the provision of technical support to all manufacturing and packaging related processes (covering all dose forms) within External Supply Pharma and Business Development (ESBD). To achieve this objective, the Technical Manager works with a multi-functional team of Procurement, Quality, Technical, Supply, Project Management, Strategy, Regulatory (incl. GPAR), Finance and Business Development professionals across the Global network in ESBD. Note, this position will require 15-20% travel, mostly domestic.
Some key responsibilities and deliverable of this role include:
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.
Supporting ongoing product supply from ES Pharma by ensuring robust and capable processes are in place and monitored.
Technical-/trouble shooting-support to ES supply teams for ongoing manufacture, packaging and supply of product from third party contractors.
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, (ESQA) that necessary validation activities have been planned and executed to current standards (e.g. Product Lifecycle Management) in line with GSK QMS by Contract Manufacturing Organizations.
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
Develop and implement a process of risk analysis / assessment for technical compliance of new and existing products and facilities.
Agree and enforce all Technical standards related to the manufacture and supply of GSK products by Contract Manufacturers, including new product introduction and validation of facilities, equipment and processes.
Ensure that any issues related to product technology at worldwide pharma contract manufacturing sites are identified, a root cause analysis conducted, and corrective actions implemented to ensure resolution.
In situations of poor Contract performance, primarily on supply delays related to technical process failure; the Technical Manager will be a key focus for rapid problem resolution with the external Contract Manufacturer. The Technical Manager is required to support achieving a rapid and significant improvement in the performance of an external Contractor over which GSK does not have direct managerial control
We are looking for professionals with these required skills to achieve our goals:
Degree in appropriate subject (Pharmacy, Chemistry, Engineering).
10 years plus of Production/Technical Operational support covering multiple Dose-Forms and Technologies with 5 years in Production/Technical Operational Support covering Parenteral Dose Forms, Aseptic processing and Technologies.
Experience in small molecule/oligo/biopharm sterile drug product processing & scale up, technology transfer, process validation, control strategy development, technical risk assessments and product lifecycle management.
Knowledge of regulatory requirements for biopharmaceutical and small molecule/oligo sterile drug product manufacture, including principles of quality by design.
Excellent interpersonal, influencing, relationship building and networking skills.
Knowledge in the following business processes:
Issue Resolution (Troubleshoot, RCA, TRA)
New Product Introduction
Multiple Dose Form Experience
Experience in one or more of the following is a plus:
Regulatory dossier update
Quality Systems (QMS)
Customer complaint and Adverse Event Reporting
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:
Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk.
Managing individual and team performance.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Implementing change initiatives and leading change.
Sustaining energy and well-being, building resilience in teams.
Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
Developing people and building a talent pipeline.
Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
Budgeting and forecasting, commercial and financial acumen.
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GSK is an Equal Opportunity/Affirmative Action Employer. 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.
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