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...

Affinivax has an exciting new opportunity for an experienced Manufacturing Technical Manager who will work closely with Manufacturing senior leadership to achieve department goals, interdepartmental manufacturing readiness, and batch release requirements. The Manufacturing Technical Manager is also responsible for owning and driving manufacturing improvement projects from concept to completion, with a particular focus on creating efficiencies that contribute to safety, quality, cost, on-time delivery, and right first-time performance. The Manufacturing Technical Manager supports by working cross-functionally with internal support departments and occasionally with external manufacturing to drive project completion.

You will have the opportunity to...

• Work independently to drive own and cross functional team performance.
• Develop a strong understanding of the manufacturing process and details of the associated hands-on operating requirements.
• Learn complex concepts and communicate the information in a way that is engaging and understood by users.
• Collaborate closely with SMEs and QA teams to create clear, concise, and technically accurate documentation.
• Perform all tasks associated with Quality Record Management and Initiation and collaboratively resolve issues.
• Own and manage Manufacturing process specific change controls, and CAPA's.
• Author Minor and Major Deviation Investigations.
• In conjunction with various internal and external stakeholders, investigates and coordinates the resolution of deviations through comprehensive use of Root Cause Analysis tools.
• Devises and implements CAPAs to address root cause and ensure effectiveness.
• Collaborate with technical and operational stakeholders, writes and/or revises SOPs, batch records, technical reports, and other operational related documents if required.
• Generate training material and conduct training for manufacturing staff.
• Execute and collaborate with MFG and cross functional SMEs on Human Error Reduction CAPAs/Right First Time Initiatives.
• Drive and own improvement projects that support department KPI's, with a focus on cost, innovation, on-time delivery, and quality. Manage projects from concept to completion; create and manage project plan, work cross- functionally and provide adequate training to impacted areas.
• Generate and Manage Metrics.
• Act as back-up to Manufacturing Management to perform Validation Protocol Review and approval.
• Support the implementation of new processes in close collaboration with Program Managers, Process Transfer/Process Development, Engineering, MSAT, QA and Validation team.
• Identify new technology for new/current assets and assist with identifying user requirements, procurement, and implementation as needed.
• Collaborate with engineering and validation teams to implement and qualify new equipment and controls.
• Represent the interests of the Manufacturing team, serve in multidisciplinary project teams, working closely with other team members in a cooperative fashion to ensure project progression.
• Be actively engage in Inspection Readiness activities and support internal and regulatory audits as needed.
• Adhere to cGMPs is always required during the manufacture and release of APIs. All personnel own the quality of what they deliver and are responsible for notifying management in a timely. manner of serious GMP deficiencies, process deviations, product defects and relevant actions.
• Perform other duties and projects as assigned, according to the changing needs of the business.

Who you are and what you bring to the team...

• A.S. or B.S. in relevant STEM field is preferred but will consider someone with High School Diploma or G.E.D. with relevant work experience in the Biotech /Life Science/ Pharmaceutical industries.
• 5+ Years of Biotech/Life Science/Pharmaceutical Biologics GMP Manufacturing related experience is required of which 2+ years has been in a biologic's leadership role.
• General knowledge of Quality/Regulatory GMP requirements in a biologics Pharma/ Biotech industry.
• The knowledge, understanding, and application of cGMP's as it relates to Commercial operations.
• Excellent written (especially technical writing), presentation and verbal communication skills.
• Superior planning, time management and coordination skills and be able to readily adapt to changes in priorities and project schedules.
• Attention to detail and good investigation, problem-solving skills.
• Prioritize and deliver work in a fast-paced, deadline-driven environment.
• The ability to adapt rapidly to a changing industry and be able to adjust responsibilities, time, and objectives accordingly.
• Strong skills in Microsoft Office, especially in Word, Excel, and PowerPoint.
• Very strong attention to detail.

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.