If you are a current Jazz employee please apply via the Internal Career site.
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.
The
Director of
Drug Product Development
is
responsible
for
providing scientific and technical leadership for
Jazz
Pharmaceuticals’
Pharmaceutical D evelopment
programs
at various stages of the development life-cycle including preformulation, formulation and process development, technical transfer and validation.
The
Director of
Drug Product Development
will
oversee
drug product aspects of
development and manufacturing projects
from
pre-formulation and
product
feasibility
through
to
clinical
trial supply
and
technology
transfer/commercialization.
In addition, the
Director of
Drug Product Development
will be expected to provide leadership of cross-functional CMC development teams.
The
Director of
Drug Product Development will have
extensive experience
in
pharmaceutical
product
development,
demonstrated problem solving ability,
module
3
authorship,
development
of
robust
manufacturing
processes
through designed
experiments
and data
analysis,
and
excellent
project
management
,
teamwork
and leadership
skills. Essential
Functions Leads the development of small molecule drug product formulations, appropriate to the phase of pharmaceutical development, with sufficient stability and robustness for clinical and/or commercial manufacturing.
Responsible
for
specifying
product
and
process
requirements, including
manufacturing
equipment
and
methods, performance
criteria, materials, test
protocols, required
analytical
methodology, packaging
(clinical
and
commercial); and
in developing
robust
processes
for
pharmaceutical
production.
Directs
projects
and leads cross-functional teams with
technical
proficiency,
scientific
creativity,
collaboration
with
others to achieve project goals on time and within budget.
Create intellectual property covering Jazz Pharmaceuticals products and ensure freedom to operate in the development of new drug products
Support the identification and selection of suitable drug product development and commercial manufacturing vendors (CMOs).
Direct technical
projects
(internally
and
at
CDMOs)
including
developing
detailed
technical
work
plans
and
managing
performance
of
vendors.
W ork
cooperatively
with, or lead,
internal
and
external
teams as required.
Author
CMC
sections
of
regulatory
dossiers
for
products
at
all
stages to enable acceptance by global regulators.
Supports asset due diligence and new product introduction and integrations
Apply current knowledge of cGMP and industry standards for process design and validation to manage vendors and contract development organizations.
Assist other department team members in
providing guidance / mentoring /
reviewing documents / data in support of product development (e.g. clinical protocols, PK study results).
Enhance and improve ways of working in Drug Product development, utilising knowledge of industry best practice
Required Knowledge, Skills, and Abilities 10 – 15 years
’
experience
in
drug
product development
in
the
pharmaceutical
industry
required.
Direct experience
with
formulation development,
process
development,
technical transfer and/or
process validation.
Demonstrated
technical
proficiency,
engineering,
collaboration
with
others, and
independent
thought.
Strong track record in delivering achievements with meaningful impact in Pharmaceutical Development projects
Demonstrated ability to lead cross-functional CMC Development teams
Demonstrated
troubleshooting
and
problem-solving
skills
including
the
use
of
designed
experiments, statistical
process
control,
Development/authorship
of
CMC
regulatory
filings
for
pharmaceutical
products.
Experience in defending processes, procedures and investigation during Regulatory Agency inspections desirable.
Track record in generating intellectual property development .
Broad
exposure
to
multiple
drug
delivery
technologies
and
knowledge
of
standard
dosage forms
.
Excellent
written
and
verbal
communication
skills, with demonstrated ability to communicate at executive leader level
Current knowledge of quality systems and FDA and EU regulations as they relate to pharmaceutical development and validation.
Proven project management skills for technical programs.
Flexibility to travel on company business when required
Required/Preferred Education and Licenses Master’s
degree,
PhD, or equivalent
combination
of
education
and
work-related
experience
required.
Description of Physical Demands Occasional mobility within office environment. Routinely sitting for extended periods of time.
Constantly operating a computer, printer, telephone and other similar office machinery.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $198,400.00 - $297,600.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here:
https://careers.jazzpharma.com/benefits.html .