Director, Head of Operations, MAPS DS
Company: Affinivax Inc.
Posted on: June 19, 2022
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 Head of Operations has functional responsibility for the
Manufacturing department and leads a matrixed cross functional
Operations Leadership Team (OLT) to produce MAPS DS under cGMP
conditions in a Lean Manufacturing environment within the
Cambridge, MA site. Operations Leadership Team (OLT) members
include Manufacturing, MSAT, QA, QC, Engineering, Facilities, EHS,
and Supply Chain, as well as adhoc team members including but not
limited to Business Operations, Finance, OE, IT. The Head of
Operations is directly responsible for: safe, high quality,
compliant, efficient product delivery, financial execution and
creating a culture where employees are fully engaged with high job
satisfaction. Additionally, the role is accountable for COGs,
supporting business growth and delivering proactive performance
improvements for the production asset via the OLT. The scope of the
role includes accountability for a multi-million-dollar annual
The MAPS DS facility is currently in start-up phase. During startup
phase, the Head of Operations is a key stakeholder accountable for
readiness for GMP manufacturing in the area. The incumbent
participates within the start-up project team to contribute GMP
Lean Operations expertise and devise creative solutions with the
start up project team to ensure the Engineering run starts on time
and subsequent manufacturing is successful.
The ideal candidate will have proven experience leading in a
world-class biopharma manufacturing organization.
You will have the opportunity to---
- Establish a team and lead to engage, retain, and develop
- Single point of accountability with authority to execute
activities and manage resources necessary for production plan
achievement. Lead the production area, managing safety, quality,
compliance and efficient, product delivery, batch release, and
financial execution. Empowered to reach across functional
- Participate in strategy decisions as a part of the Global
Manufacturing and Supply Leadership Team (GM&S LT). As a member
of the team, lead cross-functionally to implement a plan to achieve
vision and strategy.
- As leader of the Manufacturing function:
- Oversee, train and mentor the manufacturing leadership
- Create a high-performance team that emphasizes strengths-based
execution, accountability, open communication, people development
and continuous improvement. Focus on organizational sustainability
by cultivating career growth for all employees. Additionally,
identify and develop successors and top talent.
- Ensure that the manufacturing area is in a continuous state of
readiness for production and GMP audits.
- As Head of Operations:
- Must be able to lead through indirect/dotted line reporting
structure, with the ability to use influence to ensure the success
of the business and positive stakeholder outcomes.
- Partnering to deliver a safe and compliant operation.
- Driving continuous improvement activities, strategy development
and delivery, as well as supporting organizational development and
- Partnering with Quality Assurance to develop, modify,
implement, and operate quality systems aligning with corporate,
cGMP and regulatory standards.
- Be responsible for attracting and retaining skilled talent;
training and encouraging a team-centric environment that improves
- Be capable of motivating others, creating a positive work
climate where inter-departmental collaboration, coaching and
performance feedback are continuous and compulsory.
- Be capable of clearly assigning objectives, setting, measuring,
and monitoring progress, marshaling resources, and handling
- Driving implementation of lifecycle management activities to
maintain supply to patients.
- Monitor performance against production goals; identify and
- Ensure that communications are cohesive and clearly represent
an internally aligned cross-functional position including, but not
limited to, QA, MSAT, QC, Manufacturing, and other key stakeholders
as applicable, including senior management for critical
- The ability to anticipate operational issues and proactively
recommend mitigations/ solutions.
- Performing other duties as assigned.
Who you are and what you bring to the team---
- Bachelor's Degree in Science/Engineering Related field,
Master's degree preferred.
- 12-15+ years' experience in the pharmaceutical / biotechnology
industry required with 8 years in operations / manufacturing
environment preferred. Strong understanding of GMP.
- 5+ years of leadership experience at a senior or departmental
level leading multi-level organizational structures.
- Additional experience in functional areas outside of
manufacturing is a plus: MSAT, QC, QA, Engineering, etc.
- Direct experience in API/Drug Substance Operations
(Manufacturing/ support functions) a must.
- Experience hosting regulatory audits and developing audit
- Demonstrated experience in Lean Manufacturing environment.
Prior experience in a dedicated Operational Excellence or
Continuous Improvement role is a plus.
- Demonstrated project leadership skills and the ability to
develop effective working relationships with internal and external
partners and cross-functional working teams.
- Must have ability to make impactful decisions.
- Fosters a culture that embraces errors as a source of
innovation and transforms lessons learned into future proactive
- Acts as a change leader by visibly demonstrating public
commitment to change, and aligning and helping others embrace
- Communicates business strategy, measures, and tactical plans
effectively to all stakeholders and helps them make sense of
complexity and uncertainty
- Experienced at establishing clear directions, leading others,
and bringing out their best. Must be able to operate
cross-functionally for the overall success of the facility and the
- Communicates regularly with peers/team members about corporate
strategy to drive awareness and build capability
- Strong interpersonal and communication skills, both verbal and
written, with all levels of an organization
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.
Keywords: Affinivax Inc., Cambridge , Director, Head of Operations, MAPS DS, Accounting, Auditing , Cambridge, Massachusetts
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