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… Develop a strong understanding of the manufacturing process and details of the associated hands-on operating requirements.
Author and revise cGMP documents in a timely manner, under minimal supervision.
Lead the development of document templates in conjunction with cross functional stakeholders Collaborate closely with SMEs and QA teams to create clear, concise, and technically accurate documentation Problem solve for example facilitate meetings to reach alignment on topics in document where reviewers have different perspectives.
Display proficiency with the Quality Management System to create change orders for new or amended documents and obtain approvals from key project stakeholders.
Prioritize and deliver work in a fast-paced, deadline-driven environment.
Execute and collaborate with Manufacturing on Human Error Reduction CAPAs/Right First Time Initiatives.
Provide support to internal and regulatory audits as needed.
Adapt rapidly to a changing industry and be able to adjust responsibilities, time and objectives accordingly.
Perform other duties and projects as assigned, according to the changing needs of the business including but not limited to owning deviation investigations, change controls and CAPA in the Quality system.
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.
3 Years of Biotech/Life Science/Pharmaceutical Biologics GMP Manufacturing related experience is required.
General knowledge of Quality/Regulatory GMP requirements in a Pharma/ Biotech industry The possession of knowledge, understanding, and application of cGMP’s as it relates to Commercial operations.
Excellent written (especially technical writing) and verbal communication skills.
Prior experience with GMP document (eg Batch Records, WI’s, SOP’s) simplification projects is a plus.
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.
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.
The understanding and awareness of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification, and validation, manufacturing and testing activities.
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.