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 a Technical Writer with Pharma/Biotech experience to join our team to support our commercial manufacturing facility. The commercial facility is in engineering startup phase which will be followed by scale up, tech transfer and PPQ campaign prior to commercial approval. The role is accountable to prepare document templates and create, review, edit, update GMP documents. The documents are primarily SOPs, Work Instructions, Batch Records, Process Descriptions, Validation Documentation (IQ / OQ / PQ) and Technical Reports. This role will work with SMEs from peer groups in Manufacturing, Supply, Product Development, MSAT, Quality Assurance, Quality Control, Engineering, Validation to facilitate the delivery of robust accurate documents.
You will have the opportunity to...
Who you are and what you bring to the team...
What We Offer:
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.