19 days old

Technical Manager - Sterile NPI Drug Product/Aseptic Process (External Supply Pharma and Business Development)

GlaxoSmithKline
Durham, NC 27709
  • Job Code
    211699

Are you seeking an opportunity to leverage your expertise to - apply your scientific knowledge to develop robust processes for sterile NPI drug products and Aseptic process; ensure Risk Assessments and product control strategy provide Sterile 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 yes, our Technical Manager- Sterile NPI Product/ Aseptic process opportunity may be the right position for you to explore.

Location: this position may be located in one of the following locations - (1) RTP, NC; (2) Upper Merion, PA; (3) Upper Providence, PA; (4) Waltham, MA

Job Purpose

External Supply Pharma Technical is a key support function to External Supply Pharma and Business Development (ESBD) which is part of Pharma Supply Chain (PSC) and is responsible for the management of Rx CMOs (contract manufacturing organizations) Globally. (Approximately 80 CMOs Globally).

Due to our growing pipeline of assets with sourcing from external supply base, there is a need to enhance Technical capability in Sterile NPI drug Products/Aseptic processing in External Supply Pharma Technical in North America. 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 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. For an NPI, Technical manager collaborates with MPD team in R&D and in case of Sterile NPI, Technical manager works with Sterile and Biopharmaceutical Manufacturing Science and Technology group in PSC.

Note, this position will require 15-20% travel, mostly domestic. Technical Manager Sterile NPI drug product and Aseptic Process will travel to contract manufacturing organization site to support manufacture, packaging, investigations, deviations, change controls and media fills as appropriate.

Some key responsibilities and deliverables of this role include:

  • Technical process support for the introduction of Sterile New 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 BLA/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.
  • 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 / CMOs.
  • 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.

Why you?

Basic Qualifications:

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

  • Bachelors Degree in appropriate subject (Pharmacy, Life Sciences, Chemistry, Engineering).
  • Experience in small molecule/oligo/biopharma sterile NPI drug product, Aseptic processing, sterilization methods, Isolator and lyophilization technologies, scale up and technology transfer, technical risk assessments, control strategy development, process validation, product lifecycle management, continued process verification and periodic product reviews.
  • At least 5 years in Production/Technical Operational Support covering Parenteral Dose Forms, Aseptic processing and Technologies and a total of 10 years of Production/Technical Operational support covering multiple Dose-Forms and Technologies.
  • 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.

Level of knowledge in the following business processes:

  • New Product Introduction
  • Issue Resolution (RCA, TRA)
  • Validation
  • Technology Transfer
  • Regulatory dossier update
  • Deviation management
  • Due Diligence
  • Working with CMOs

Preferred Qualifications:

Experience in one or more of the following is a plus:

  • BLA/MAA preparation and PAI support
  • Operational Excellence
  • Change Control
  • Product Release
  • Performance Management
  • Quality Systems (QMS)

Why GSK?

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.

*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/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.

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 GSKs compliance to all federal and state US Transparency requirements. For more information, please visit GSKs Transparency Reporting For the Record site.







Posted: 2019-10-23 Expires: 2019-11-21
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Technical Manager - Sterile NPI Drug Product/Aseptic Process (External Supply Pharma and Business Development)

GlaxoSmithKline
Durham, NC 27709

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