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.
Reporting to VP, Global Manufacturing and Supply, the Senior Director, Head MSAT will be a member of the Global Manufacturing and Supply Leadership Team (GM&S LT). Functions within the scope of the role are Engineering, Validation, Automation and Manufacturing Sciences. The Senior Director, Head MSAT is responsible for technical manufacturing support in accordance with current good manufacturing practices (cGMP) for Affinivax internal manufacturing and CMO production sites. The candidate will provide leadership for MSAT activities to deliver robust and reliable production processes which are designed, validated, and commercialized to ensure continuous supply to patients. The candidate will foster an environment that encourages innovation and continuous improvement, whilst partnering with Process Development, Regulatory, EHS, Quality, Manufacturing and Facilities groups.
You will have the opportunity to...
- Build an expert MSAT team and develop a highly engaged organization.
- (In association with Process Development), be accountable for the successful process facility fit of MAPS Drug Substance to commercial scale internal facility or other TT to CMO's using robust risk management practices.
- Provide technical process leadership to manufacturing ensuring systematic process understanding to support successful Phase 3, PPQ and future commercial manufacturing.
- Partner with Manufacturing to ensure that Manufacturing operations are set up for success through the provision of high-quality batch records, robust processes, and new technology. Anticipate, respond to, and resolve issues that arise during production through use of master data, process & product monitoring, etc.
- Establish systems and procedures to enable proactive process monitoring and analysis of manufacturing process data, establishing key performance indicators in conformance with license requirements, cGMPs, regulations, site procedures and represent a state of compliance during Health Authority inspections. Track and communicate manufacturing process KPIs in real time throughout manufacturing campaigns as a mechanism of driving a culture of continuous improvement.
- Leverage process expertise and Operational Excellence approaches to support process/operational deviations and manufacturing investigations, owning impact assessment, driving root cause identification, and supporting timely close-out of investigations and corrective actions.
- Develop and draft study plans and protocols as required to support regulatory requirements, deviations response, process changes, raw material qualification etc.
- Promote innovation with respect to identification, evaluation and implementation of new process technologies, new products, troubleshooting complex issues or improvement to existing commercial products throughout the product lifecycle.
- Be responsible for Process Performance Qualification (PPQ), Continued (Ongoing) Process Verification (CPV/OPV) and Annual Product Reviews (APRs)/Product Quality Reviews (PQRs/APRs) during lifecycle management.
- Author Sections of regulatory filings and support the review of CMC part of regulatory submissions and Health Authority requests.
- Represent MSAT on CMC team and provide technical leadership to drive alignment of critical decisions and risk mitigations within CMC functions to ensure timely delivery of lifecycle management milestones.
- Be accountable for facility, equipment and computer system validation with the planning and execution of commissioning and validation protocols.
- Be accountable for Automation Technology Part 11 compliance for the GMP areas.
- Support Procurement/Sourcing by providing technical expertise for 'process fit' evaluations.
- Proactively promote positive Safety Culture and a cGMP compliance mindset.
- Be accountable for overall budget and financial performance of the MSAT organization.
Who you are and what you bring to the team...
- A bachelor's Degree in Science/Engineering Related field, Master's degree preferred.
- A minimum of 15 years of experience in the early, late and commercial phases of biopharmaceutical development and manufacturing.
- A minimum of 8 years of experience in the manufacture of biologic molecules; vaccine and microbial fermentation production preferred.
- A minimum of 8 years of leadership experience.
- Prior experience in either design, qualification, start-up or initial licensure of Biologics Manufacturing facilities preferred.
- Demonstrated evidence of deep process, equipment, automation, validation, and technical knowledge.
- Thorough understanding and demonstrated experience with FMEA, risk analysis, process characterization, process validation and market application regulatory strategies for biologic molecules.
- Knowledge in CMC strategy, ICH guidelines, and regulatory support tasks (IND, BLA, RTQ, and PAI).
- Extensive knowledge of quality systems, cGMP, regulatory and industry standards at all phases of drug development.
- Understanding of, and experience with, global regulations pertaining to cGMP manufacturing and analytical requirements for Raw Materials, Critical Components, Drug Substance and Drug Product and the translation of those regulations into process development work products and commercial process design.
- Demonstrated expertise overseeing multiple tech transfer and scale up of biologic molecules including associated regulatory inspections.
- Experience with statistics in the areas of statistical process control, modeling, and data management.
- Computer skills (MS Office Suite, JMP statistical software, Visio, LIMS, SAP, etc).
- Proven ability to deliver results successfully, collaborating with multi-cultural and geographically diverse teams.
- Demonstrated project leadership skills and the ability to develop effective working relationships with internal and external partners, direct/indirect reports, and cross-functional working teams.
- Strong critical thinking skills and an ability to make impactful decisions.
- The ability to foster a culture that embraces lessons learned as a source of innovation to transform into future proactive mindset.
- Someone who acts as a change leader by visibly demonstrating public commitment to change and aligning and helping others embrace change.
- Experienced at establishing clear directions, leading others, and bringing out their best.
- Regular communication with peers/team members about corporate strategy to drive awareness and build capability.
- The ability to communicate clearly and precisely, both orally and in writing, is essential.
- High motivation, the ability to multi-task, prioritize, has strict attention to detail and takes full ownership for successful execution of tasks.
- May require up to 20% travel when necessary.
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
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.