Technical Manager, NPI Drug Product North America
- Research Triangle Park, NC
Site Name: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence, USA - North Carolina - Research Triangle Park
Posted Date: Mar 1 2021
Are you looking for an opportunity to apply your scientific knowledge to develop robust processes for New product Introduction (NPI) of small molecule oral solid drug products at Contract Manufacturing Organizations; ensure Risk Assessments and product control strategy provide product robustness at launch and is maintained throughout the life cycle through application of continued process verification; work with and influence external (Contract Manufacturing Organizations) supply base to deliver the strategy and meet the demands of the Pharma Supply Chain to provide quality product to the patient? If so, our Technical Manager- NPI Drug Product opportunity may be the right position for you to explore.
Due to our growing pipeline of assets with sourcing from external supply base, there is a need to enhance Technical capability in NPI small molecule drug products (Oral solids) in External Supply Pharma Technical in North America. The Technical Manager is responsible and accountable for the provision of technical support to all manufacturing and packaging related processes within External Supply Pharma. 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 ES. For an NPI, Technical manager collaborates with MPD (Medicine and Product Delivery) team in R&D. Minimal travel is required.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- Technical process support for the introduction of New small molecule oral solid Drug 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 mid-late phase portfolio projects and provide Pharma Supply Chain Technical input into design selection and manufacture considerations.
- Provide Pharma Supply Chain Technical input into developing product control strategy, author relevant sections of NDA/MAA, conduct OpTRA with contract manufacturers and ensure implementation of product control strategy on to shop floor/manufacturing operations.
- 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.
- Maintain product robustness through development and post launch through continued process verification plan and periodic product reviews. Support ongoing product supply from ES Pharma by ensuring robust and capable processes are in place and monitored.
- Ensure that any issues related to product technology at pharma contract manufacturing sites are identified, a root cause analysis conducted, and corrective actions implemented to ensure resolution.
- 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 between R&D and PSC.
- Impact assessment and support of the process changes (GSK or Contract Manufacturing Organization driven) related to active materials, excipients, primary and secondary packaging materials including 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.
- Develop and implement a process of risk analysis / assessment for technical compliance of new and existing products and facilities.
- Technical project support including deviations and change controls related to all manufacturing/packaging related projects at Contract Manufacturing Organizations.
- Apply 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
- 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
- Technical Manager NPI Drug Product may travel to contract manufacturing organization site to support manufacture, validation, packaging, deviations, investigations and change controls as appropriate.
Why you? Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's Degree in appropriate subject (Pharmacy, Life Sciences, Chemistry, Engineering).
- Experience in small molecule NPI oral solid drug product processing, scale up and technology transfer, technical risk assessments, control strategy development, CMC regulatory documentation process validation, product lifecycle management, continued process verification and periodic product reviews.
- 10 years of Production/Technical Operational support covering multiple Dose-Forms and Technologies.
- Experience with the following business processes but not limited to: New Product Introduction; Issue Resolution (RCA, TRA); Multiple Dose Form Experience; Validation; Product Transfer; Regulatory dossier update; Deviation management; and Due Diligence
If you have the following characteristics, it would be a plus:
- Knowledge of regulatory requirements for small molecule drug product manufacture, including principles of quality by design.
- Excellent interpersonal, influencing, relationship building and networking skills.
- Experience in one or more of the following is a plus: Quality Systems (QMS) NDA/MAA preparation and PAI support; Operational Excellence; Change Control; Product Release; and Performance Management
Our values and expectationsare 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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