Affinivax Associate Director, Process Validation in Cambridge, Massachusetts
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.
Affinivax is looking for an energetic Associate Director, Process Validation to join the Manufacturing Science and Technology team. We are looking for a candidate with excellent scientific, technical, operations, communication, and project management skills. This individual will work in a fast-paced team environment, collaborating with colleagues across functions in the site and global organizations to secure the commercialization of the next generation Pneumococcal vaccine. We look forward to working with a process validation leader with demonstrated experience in execution of process validation programs from master plans through protocols and authoring reports for a biologics process. The Associate Director, Process Validation will facilitate new commercial product introduction through Process Performance Qualification (PPQ) and associated studies required to support regulatory filing submission and Pre-Approval Inspection (PAI), then maintain a validated state during Continuous Process Validation (CPV) program. The candidate will apply sound judgment and effective decision making to drive the strategic objectives of the program and influence the broader business.
You will have the opportunity to…
Be responsible for establishing and maintaining the procedures, business processes and tools for process validation and process monitoring/analytics.
Develop process validation strategies and process monitoring programs adhering to industry standards (FDA, PDA, ICH and BPOG guidance’s).
Be responsible for translating the critical process parameters and the process control strategy into a focused process validation plan.
Establish, write, maintain Process Validation Master Plan (PVMP) for product manufacturing stages.
Design PV studies to meet the stated intent including development of acceptance criteria.
Author and review PV Protocols.
Support the Operations team to ensure the PVMP activities are executed and maintained as defined in PVMP.
Review data to ensure accuracy and completeness. Effectively trend and chart data for process validation reports.
Process Validation lead during inspections, meetings, and teleconferences regarding process validation topics with Regulatory agencies. Provides related responses to inspections and audit observations.
Identify potential root causes of variation and deviations using a systematic approach. Expertise in use / application of variety of problem-solving tools e.g. Ishikawa, Kepner-Tregoe (KT), five-whys, etc. Resolve complex problems and lead multidisciplinary teams in developing and implementing solutions.
Ensure that all process validation activities are performed in accordance with current regulations and guidance, handling any deviations associated to these activities.
Maintain knowledge on all industry trends for process validation and monitoring.
Coach junior staff and drive to best practices.
Develop a thorough understanding of manufacturing processes and related process equipment.
Other duties as required.
Who you are and what you bring to the team…
8+ years of experience in Manufacturing, Manufacturing Science & Technology, CMC or Quality which includes 4+ years of experience in executing process validation, having led and managed validation projects.
Vaccines and/or Biologics experience required.
Thorough understanding of industry guidance’s (FDA, PDA, ICH and BPOG), knowledge of FDA, EMA and ICH regulations, and understanding of product development life cycle.
Experience working in a cGMP manufacturing environment.
Experience presenting topics during regulatory inspections and leading the preparation of Pre-Approval Inspection (PAI) process validation topics.
Knowledge of statistical methods used for Pharmaceutical Process Analysis.
The ability to manage multiple projects and resources is required. The candidate should have the ability to drive direction and have excellent communication skills to influence company objectives.
Depth of experience writing technical reports/protocols.
Knowledge of intermediate to advanced statistical analyses such as T-tests, F-tests, box-plots, understanding p values, etc. as well as control charting, Nelson’s/Shewart’s rules (or other statistical trending rules), etc., using mainstream statistical software analysis program such as SAS, MiniTab, or JMP
Demonstrated ability to build and maintain productive relationships to foster collaboration and continued process improvement.
Strong leadership and interpersonal skills as well as excellent presentation and scientific/technical writing skills.
Attention to detail, strong organizational skills, and ability to multi-task, problem-solve, and adjust priorities to meet goals in a fast-paced environment.
Experience in leading a team of direct reports and providing guidance and mentorship to junior engineers or scientists.
Experience in leading cross-functional collaborations with other departments (MSAT, Operations, QC, QA, Regulatory, PD) as well as external CDMOs.
What We Offer:
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
401(k) Plan with a 4% match
Generous PTO package
11 paid holidays, plus Holiday Shutdown
Commuter Reimbursement Program
Brand new facility in Kendall Square
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.
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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