Director, Head of Operations, MAPS DS

Company: Affinivax Inc.
Location: Cambridge
Posted on: June 19, 2022

Job Description:

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---

The Head of Operations has functional responsibility for the Manufacturing department and leads a matrixed cross functional Operations Leadership Team (OLT) to produce MAPS DS under cGMP conditions in a Lean Manufacturing environment within the Cambridge, MA site. Operations Leadership Team (OLT) members include Manufacturing, MSAT, QA, QC, Engineering, Facilities, EHS, and Supply Chain, as well as adhoc team members including but not limited to Business Operations, Finance, OE, IT. The Head of Operations is directly responsible for: safe, high quality, compliant, efficient product delivery, financial execution and creating a culture where employees are fully engaged with high job satisfaction. Additionally, the role is accountable for COGs, supporting business growth and delivering proactive performance improvements for the production asset via the OLT. The scope of the role includes accountability for a multi-million-dollar annual operating budget.

The MAPS DS facility is currently in start-up phase. During startup phase, the Head of Operations is a key stakeholder accountable for readiness for GMP manufacturing in the area. The incumbent participates within the start-up project team to contribute GMP Lean Operations expertise and devise creative solutions with the start up project team to ensure the Engineering run starts on time and subsequent manufacturing is successful.

The ideal candidate will have proven experience leading in a world-class biopharma manufacturing organization.

You will have the opportunity to---

• Establish a team and lead to engage, retain, and develop colleagues.
• Single point of accountability with authority to execute activities and manage resources necessary for production plan achievement. Lead the production area, managing safety, quality, compliance and efficient, product delivery, batch release, and financial execution. Empowered to reach across functional areas.
• Participate in strategy decisions as a part of the Global Manufacturing and Supply Leadership Team (GM&S LT). As a member of the team, lead cross-functionally to implement a plan to achieve vision and strategy.
• As leader of the Manufacturing function:
  • Oversee, train and mentor the manufacturing leadership team.
  • Create a high-performance team that emphasizes strengths-based execution, accountability, open communication, people development and continuous improvement. Focus on organizational sustainability by cultivating career growth for all employees. Additionally, identify and develop successors and top talent.
  • Ensure that the manufacturing area is in a continuous state of readiness for production and GMP audits.
  • As Head of Operations:
    • Must be able to lead through indirect/dotted line reporting structure, with the ability to use influence to ensure the success of the business and positive stakeholder outcomes.
    • Partnering to deliver a safe and compliant operation.
    • Driving continuous improvement activities, strategy development and delivery, as well as supporting organizational development and cultural leadership.
    • Partnering with Quality Assurance to develop, modify, implement, and operate quality systems aligning with corporate, cGMP and regulatory standards.
    • Be responsible for attracting and retaining skilled talent; training and encouraging a team-centric environment that improves business performance.
    • Be capable of motivating others, creating a positive work climate where inter-departmental collaboration, coaching and performance feedback are continuous and compulsory.
    • Be capable of clearly assigning objectives, setting, measuring, and monitoring progress, marshaling resources, and handling competing priorities.
    • Driving implementation of lifecycle management activities to maintain supply to patients.
    • Monitor performance against production goals; identify and resolve gaps.
    • Ensure that communications are cohesive and clearly represent an internally aligned cross-functional position including, but not limited to, QA, MSAT, QC, Manufacturing, and other key stakeholders as applicable, including senior management for critical topics.
    • The ability to anticipate operational issues and proactively recommend mitigations/ solutions.
    • Performing other duties as assigned.
      Who you are and what you bring to the team---
      
      • Bachelor's Degree in Science/Engineering Related field, Master's degree preferred.
      • 12-15+ years' experience in the pharmaceutical / biotechnology industry required with 8 years in operations / manufacturing environment preferred. Strong understanding of GMP.
      • 5+ years of leadership experience at a senior or departmental level leading multi-level organizational structures.
      • Additional experience in functional areas outside of manufacturing is a plus: MSAT, QC, QA, Engineering, etc.
      • Direct experience in API/Drug Substance Operations (Manufacturing/ support functions) a must.
      • Experience hosting regulatory audits and developing audit presentations
      • Demonstrated experience in Lean Manufacturing environment. Prior experience in a dedicated Operational Excellence or Continuous Improvement role is a plus.
      • Demonstrated project leadership skills and the ability to develop effective working relationships with internal and external partners and cross-functional working teams.
      • Must have ability to make impactful decisions.
      • Fosters a culture that embraces errors as a source of innovation and transforms lessons learned into future proactive mindset.
      • Acts as a change leader by visibly demonstrating public commitment to change, and aligning and helping others embrace change
      • Communicates business strategy, measures, and tactical plans effectively to all stakeholders and helps them make sense of complexity and uncertainty
      • Experienced at establishing clear directions, leading others, and bringing out their best. Must be able to operate cross-functionally for the overall success of the facility and the business.
      • Communicates regularly with peers/team members about corporate strategy to drive awareness and build capability
      • Strong interpersonal and communication skills, both verbal and written, with all levels of an organization
        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.

Keywords: Affinivax Inc., Cambridge , Director, Head of Operations, MAPS DS, Accounting, Auditing , Cambridge, Massachusetts