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Director, MSAT

Company: GlaxoSmithKline
Location: Cambridge
Posted on: January 26, 2023

Job Description:

Site Name: Cambridge Binney StreetPosted Date: Dec 19 2022Our patients deserve bold, ambitious ideasWe make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021.We continue to modernise, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together.Reporting to Site Lead, GIO Binney Street, the Director, Head MSAT will be a member of the GIO Binney Site Leadership Team. Functions within the scope of the role are Manufacturing Science and Technology and Process Validation. The Director, Head MSAT is responsible for establishing the expertise and business processes in the MSAT and Process Validation (PV) organizations to deliver robust and reliable production processes which are designed, validated, and commercialized to ensure continuous supply to patients. The incumbent is accountable for providing technical support of day-to-day GMP operations, setting strategies to maximize yield, capacity, process robustness and reliability as well as fostering a culture of continuous improvement and innovation to ensure the supply of vaccines to patients. The role partners closely with Process Development, Regulatory, EHS, Quality, Manufacturing and Engineering / Facilities groups.Key Responsibilities

  • Build an expert MSAT team and develop a highly engaged organization with robust succession planning.
  • Proactively promote positive Safety Culture and a cGMP compliance mindset.
  • (In association with Process Development), be accountable for the successful process facility fit of MAPS Drug Substance to commercial scale internal facility or other TT to CMO's using robust risk management practices.
  • Provide technical process leadership to manufacturing ensuring systematic process understanding to support successful Phase 3, PPQ and future commercial manufacturing.
  • Partner with Manufacturing to ensure that Manufacturing operations are set up for success through the provision of high-quality batch records, robust processes, and new technology. Anticipate, respond to, and resolve issues that arise during production through use of master data, process & product monitoring, etc.
  • Establish systems and procedures to enable proactive process monitoring and analysis of manufacturing process data. Core stakeholder to establish automation strategy for the site.
  • Develop key performance indicators in conformance with license requirements, cGMPs, regulations, site procedures which will represent a state of compliance during Health Authority inspections. Track and communicate manufacturing process KPIs in real time throughout manufacturing campaigns as a mechanism of driving a culture of continuous improvement.
  • Leverage process expertise and continuous improvement approaches to support process/operational deviations and manufacturing investigations, owning impact assessment, supporting data provision for true root cause identification, and supporting timely close-out of investigations and corrective actions.
  • Develop and draft study plans and protocols as required to support regulatory requirements, deviations response, process changes, raw material qualification etc.
  • Promote innovation with respect to identification, evaluation and implementation of new process technologies, new products, troubleshooting complex issues or improvement to existing commercial products throughout the product lifecycle.
  • Be responsible for Process Performance Qualification (PPQ), Continued (Ongoing) Process Verification (CPV/OPV) and Annual Product Reviews (APRs)/Product Quality Reviews (PQRs/APRs) during lifecycle management.
  • Author Sections of regulatory filings and support the review of CMC part of regulatory submissions and Health Authority requests.
  • Represent MSAT on TDT(CMC) team and provide technical leadership to drive alignment of critical decisions and risk mitigations.
  • Work with global MSAT to identify and implement timely delivery of lifecycle management milestones.
  • Support Procurement/Sourcing by providing technical expertise for 'process fit' evaluations.
  • Be accountable for overall budget and financial performance of the MSAT organization.Why you?Basic Qualifications:
    • A minimum of 15 years of experience in the early, late and commercial phases of biopharmaceutical development and manufacturing.
    • A minimum of 8 years of experience in the manufacture of biologic molecules; vaccine and microbial fermentation production preferred.
    • A minimum of 8 years of leadership experience.
    • Must have prior experience in either design, qualification, start-up or initial licensure of Biologics Manufacturing facilities.
    • Must have prior experience with Tech Transfer facility fit, process comparison gap assessment and mitigations
    • Demonstrated evidence of deep process, equipment, automation, validation, and technical knowledge.
    • Thorough understanding and demonstrated experience with FMEA, risk analysis, process characterization, process validation and market application regulatory strategies for biologic molecules.
    • Knowledge in CMC strategy, ICH guidelines, and regulatory support tasks (IND, BLA, RTQ, and PAI).
    • Extensive knowledge of quality systems, cGMP, regulatory and industry standards at all phases of drug development.
    • Understanding of, and experience with, global regulations pertaining to cGMP manufacturing and analytical requirements for Raw Materials, Critical Starting Materials, Drug Substance and the translation of those regulations into process development, tech transfer facility fit and commercial process design.
    • Experience with statistics in the areas of statistical process control, modeling, and data management.
    • Computer skills (MS Office Suite, JMP or equivalent statistical software, Visio, LIMS, SAP, etc).
    • Proven ability to deliver results successfully, collaborating with multi-cultural and geographically diverse teams.
    • Demonstrated project leadership skills and the ability to develop effective working relationships with internal and external partners, direct/indirect reports, and cross-functional working teams.
    • Strong critical thinking skills and an ability to make impactful decisions.
    • The ability to foster a culture that embraces lessons learned as a source of innovation to transform into future proactive mindset.
    • Someone who acts as a change leader by visibly demonstrating public commitment to change and aligning and helping others embrace change.
    • Experienced at establishing clear directions, leading others, and bringing out their best.
    • Regular communication with peers/team members about corporate strategy to drive awareness and build capability.
    • The ability to communicate clearly and precisely, both orally and in writing, is essential.
    • High motivation, the ability to multi-task, prioritize, has strict attention to detail and takes full ownership for successful execution of tasks.
    • May require up to 10% travel when necessary.Preferred Qualifications:
      • A bachelor's Degree in Science/Engineering Related field, Master's degree preferred.Why GSK?We're all driven by the same powerful purpose, but it's this culture that powers our performance, ensuring we achieve the challenge we've set ourselves of getting ahead together. And it's by prioritising performance, innovation, and trust that we continue to operate responsibly for all our stakeholders and improve the lives of billions, every day.#GSKBinneyStreet#LI-GSKGSK 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 organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.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.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/ AgenciesGSK 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 site.

Keywords: GlaxoSmithKline, Cambridge , Director, MSAT, Executive , Cambridge, Massachusetts

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