Senior Director, Drug Product - Gene Therapy
Company: Ultragenyx Pharmaceutical
Posted on: January 11, 2021
Senior Director, Drug Product - Gene Therapy Woburn, MA /
Ultragenyx - Gene Therapy - Manufacturing and Plant Operations /
Ultragenyx is a commercial-stage biopharmaceutical company
committed to developing and commercializing novel therapies for the
treatment of rare and ultra-rare genetic diseases. The company has
rapidly built a diverse portfolio of small molecules, biologics,
gene therapies and nucleic acids to target debilitating genetic
diseases for which the unmet medical need is high, the biology for
treatment is clear, and for which there are typically no approved
therapies treating the underlying disease. Ultragenyx Gene Therapy
is headquartered in Cambridge, MA with additional locations in
Woburn, MA. We are looking for exceptional individuals who share
our passion for developing novel therapies to treat rare diseases
and advancing the field of gene therapy. Developing new treatments
for rare genetic diseases is challenging work. It takes courage,
talent, and dedication to look past the easy answers and uncover
new solutions that can make a meaningful impact. At Ultragenyx we
push each other to perform at our very best, because we never lose
sight of our mission - to make a difference in our patients' lives.
Come join our team during this exciting time of growth and
opportunities!-- During the COVID-19 Outbreak we are committed to
our hiring process. The health and safety of our employees and
prospective employees take priority which means at this time our
process will include remote based web-ex video discussions,
interviews & onboarding. Position Summary The Senior Director, Drug
Product role is an exciting, dynamic position intended to set-up
and manage Ultragenyx first internal DP facility, inclusive of drug
product manufacturing, and primary labeling and packaging. The
Senior Director will oversee material supply and the departmental
budget. The individual will be reporting to the Site Head for the
Manufacturing facility. Responsibilities
- Lead drug product manufacturing, engineering, and validation
activities for the DP facility, staff recruitment and
- Ability to work in a small company, fast-paced, environment,
multi-task and contribute to many different functions.Resolve
clinical and commercial manufacturing issues being mindful of
Supply, Quality, and Regulatory through effective management of
deviations and change control development and implementation, CAPA
management and risk assessment.
- Ensure ongoing production of timely, quality drug product by
leading tech transfer, manufacturing, technical support, and
process monitoring/trending activities
- Establish and maintain an understanding of current trends,
emerging process technologies and ensure full awareness of current
and emerging global capabilities for DP production.
- Execute Quality by Design (QbD) principles to define the design
space and develop overall control strategy.
- Develop technical summaries and contribute to regulatory
- Create, review and approve technical documents including batch
records, engineering / development reports, Validation Master Plans
and PPQ reports. Requirements
- BS/MS in Engineering or Life Sciences or equivalent experience
with minimum 12 years working in biotech company with focus on
Development and Manufacturing collaborations
- --Specific experience with DP operations a must.
- Must be organized and have excellent oral and written
- Strong interpersonal skills.
- Attention to detail is essential.
- Must be able to handle confidential information and issues
- Demonstrated proficiency on Microsoft office applications
(Outlook, Word, Excel, Project, PowerPoint)
- Ability to operate independently and seek out guidance and
expertise internally and externally as needed.
- Ability to identify and resolve problems in a timely manner and
independently analyze information skillfully.
- Team oriented, with a good sense of humor, sound judgment,
self-motivation and willingness to take initiative.
- Must be able to make informed risk decision and on occasion
work with limited or rapidly changing data to drive timelines and
decisions. #LI-CZ1 Ultragenyx Pharmaceutical is an equal
opportunity employer & prohibits unlawful discrimination based on
race, color, religion, gender, sexual orientation, gender
identity/expression, national origin/ancestry, age, disability,
marital and veteran status. Reasonable accommodation will be
provided for qualified individuals with disabilities and for
qualified disabled veterans in job application procedures, as
required by applicable law. If you have any difficulty using our
online application system and need an accommodation due to a
disability, you may contact--Talent Acquisition--by calling:--(415)
483-8800--or by--emailing--us firstname.lastname@example.org
. For electronic email and mail inquiries, please include a
description of your requested accommodation, your name and contact
information. Note to External Recruiters: All candidate activity
and open positions are managed strictly through our Human Resources
Department. Our Human Resources Department kindly requests that
recruiters not contact employees/hiring managers directly in an
attempt to solicit business and present candidates. Please note
that failure to comply with this request will be a factor in
determining a professional relationship with our organization.
Submission of unsolicited resumes prior to an agreement set in
place between the Human Resources Department and the recruiting
agency will not create any implied obligation. Inquiries on
developing a recruiting relationship with us, may be directed
Keywords: Ultragenyx Pharmaceutical, Cambridge , Senior Director, Drug Product - Gene Therapy, Executive , Cambridge, Massachusetts
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