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Affinivax Operational Excellence Leader in Cambridge, Massachusetts

About Affinivax

Affinivax is a Cambridge-based clinical-stage biotechnology company with a novel, next-generation approach to the development of vaccines and immunotherapies targeting infectious and other immune-mediated diseases. This novel and highly efficient vaccine technology – called Multiple Antigen Presenting System (MAPS) – enables the high-affinity binding of protective polysaccharides as well as proteins in a single vaccine, uniquely inducing a broad and protective B-cell and T-cell immune response. Our vision is to take a major step forward in vaccine innovation to prevent and combat a wide range of infectious and other immune-mediated diseases, protecting infants and adults in our communities and making a meaningful impact on global public health. Affinivax is focused on developing vaccines for the most challenging bacterial infections, with a goal of improving upon existing vaccines and providing solutions for where there are no vaccines or prevention strategies available today.

The role…

Within the Business Excellence team, this role will partner with internal customers to identify and drive high-impact improvement efforts in support of site priorities and strategies by fostering the CI culture on the site to deliver sustainable business performance.

This role provides services to internal customers to teach Lean / Six Sigma methodology aligned with the GPS (GSK Production System) Vaccines vision and the Site GPS Masterplan. This includes teaching both basic & advanced OE methods and tools and mentoring customers in the application of OE methods and tools, by focusing the organization on the relentless elimination of non-value-added activities (waste), variation and variability, to result in sustainable and tangible impact and added value on the performance of the site/ function.

This role includes the responsibility for engaging employees at all levels, for building the CI capabilities, for creating ownership and imbedding CI in our DNA, for successfully delivering against the annual GPS Masterplan activities, and for ensuring sustainability of CI.

You will have the opportunity to…

  • Drive the continued deployment of Continuous Improvement (CI) Culture at the site, to include specific actions to address identified improvement opportunities in alignment with the GPS Masterplan and the GPS maturity assessments.

  • Conduct, lead and/or facilitate workshops to uncover CI opportunities (for example, value stream mapping to identify bottlenecks and areas of improvement).

  • Ensure the deployment of the GPS toolkit with a strong focus on Visual Management that will allow the teams to identify variability & wastes in their areas. Design Key Performance Indicators (KPIs) and dashboards, design collection/reporting processes and lead administrative teams in gathering and reporting site KPIs.

  • Utilize Digitalization opportunities to reduce Lean WASTE in the site processes, drive simplification for the customer, and leverage and create electronic visual management tools.

  • Build site/ function CI capabilities at different Lean / Six Sigma expertise levels in line with the GPS Masterplan. Coach, influence, and mentor “Belt” candidates to increase skills and their value to the business.

  • Employ disciplined work processes to manage customer relationships to ensure common understanding of mutual requirements and expectations, regular communication of status of deliverables, and direct evidence of performance against success criteria.

  • Demonstrated familiarity and compliance with cGMP's, EHS procedures and regulations, facility regulatory guidelines, and standard operating procedures.

  • Partner with customers and apply, adapt and develop advanced, expert Lean Six Sigma methods and tools to drive initiatives that will increase utilization, reduce waste, improve profitability, and improve general ways of working.

  • Lead, motivate and facilitate cross-functional teams to commit to, and deliver results.

  • Employ benchmarking techniques, both within and outside GSK, to leverage good practice, share knowledge, and deploy best known methods, as appropriate.

  • Design, plan and facilitate effective, efficient meetings and workshops, and mentor others in meeting planning and facilitation.

    Who you are and what you bring to the team…

  • An understanding of and familiarity with advanced Lean / Six Sigma methodologies as demonstrated by a minimum Green Belt certification

  • A demonstrated performance in using a Lean Production System to drive business performance

  • Proficiency with MS Office applications including Excel, PowerPoint and Word.

  • Proficiency in mathematics and statistics including the ability to understand algebra and geometry; a working knowledge of Statistical Process Control / Quality Engineering preferred.

  • The ability to make oral group presentations and facilitate team discussions to include persuading others, providing information, explaining concepts, adopting Lean / Six Sigma principles or actions, and delivering business cases.

  • An ability to lead complex problem solving / root cause analysis sessions to accurately identify patterns, relationships and formulate logical and objective conclusions adhering to DMAIC methodologies.

  • An ability to manage multiple projects simultaneously to achieve deliverables and adhere to timelines and budgets.

  • An ability to communicate both verbally and in writing with all levels of the organization. The ability to communicate ideas and concepts in a clear, compelling way.

  • An ability to persuade and influence functional area leaders and staff to drive change.

  • Able to interact in multidisciplinary environment including engineering, facility operations, validation, production, and QC\QA. Ability to work across functional disciplines.

  • A sense of urgency, flexibility, and accountability.

  • A committed team player prepared to work in and embrace the Value Stream culture.

  • An ability to follow written procedures and document results in a neat and precise manner.

  • Maintain attention to detail, while completing multiple or repetitive tasks.

  • Demonstration to a serious commitment to accuracy and quality while meeting goals or deadlines.

    What We Offer:

  • Competitive compensation

  • Medical and Dental plans (BCBS), employer-paid at 85%

  • Vision Insurance, employer-paid at 100%

  • Life Insurance, Short- and Long-Term Disability

  • Flexible Spending Accounts/Health Savings Accounts

  • Wellness Benefits

  • 401(k) Plan with a 4% match

  • Tuition Reimbursement

  • Generous PTO package

  • 11 paid holidays, plus Holiday Shutdown

  • Pet Insurance

  • Subsidized Parking

  • Commuter Reimbursement Program

  • Brand new facility in Kendall Square

    Please Note: In accordance with Affinivax’s duty to provide and maintain a safe workplace that is free of known hazards, we have adopted a COVID-19 vaccine policy to protect the health of our employees and their families, our visitors, and the community at large from COVID-19. This policy requires all employees, contractors, and temporary workers, to (1) obtain an approved vaccination and provide proof of vaccination or (2) request an accommodation for a medical or religious exemption. Our policy is based on guidance from the Centers for Disease Control (CDC) and Prevention.

    Affinivax is committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, disability, genetic information, status as a veteran or as a member of the military or status in any group protected by applicable federal or state laws.

    Agencies: All resumes submitted by search firms/employment agencies to any employee at Affinivax via email, the internet, or in any form and/or method will be deemed the sole property of Affinivax, unless such search firms/employment agencies were engaged by Affinivax for this position and a valid agreement with Affinivax is in place. In the event a candidate who was submitted outside of the Affinivax agency engagement process is hired, no fee or payment of any kind will be paid.

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