Associate Director, Early Stage Analytical DevelopmentJazz Pharmaceuticals • London, England, United Kingdom
Associate Director, Early Stage Analytical Development
Jazz Pharmaceuticals
- London, England, United Kingdom
- London, England, United Kingdom
Über
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 for more information.
Reporting
into
the
Snr Director Analytical Development, this is an opportunity to join the Small Molecule Development team within Jazz Pharmaceuticals. The role will provide scientific and technical leadership
for analytical development
at various stages of drug development
both internal and external through CDMO
with particular emphasis on research and early development (pre-DP0)
including material characterization, analytical method assessment,
forced degradation
development, transfer, validation and tr
oubleshooting of methods. The position will lead analytical activities for research/early development programs
and
late stage
development programs
.
Activities may be performed internally or with external vendors. Other responsibilities will include cross-functional team membership
and/or leadership
, authoring and/or reviewing method validation protocols and reports, technical reports, authoring or reviewing CMC aspects of regulatory dossiers
and participation in department or functional initiatives
.
The role will play a key part in shaping analytical strategies prior to DP0
and during IND enabling
activities
, where speed, pragmatism and phase-appropriate control strategies are critical.
The role will involve significant cross functional collaboration with other functions including Quality, CMC Regulatory, Manufacturing, and New Product & Technology Integration working towards agile new product introduction and ensuring all
methods
are understood, robust, efficient
,
in control
and phase
appropriate
.
The role is both project and operations orientated. It
shall
require
an
ability to drive and deliver multiple projects concurrently.
Essential Functions Lead analytical method development, validation,
transfer
and stability evaluations
, supporting early stage
(pre-DP0 through IND)
,
and
late stage
development
products
both internally and externally by directing CDMO/CRO.
Define fit-for-purpose analytical packages
and specifications
for preclinical and early clinical programs, balancing speed, scientific
understanding
and regulatory expectations
Represent analytical development on cross-functional CMC product development teams
influencing candidate selection, developability assessment and early control strategy decisions
Ensure that all
analytical methods
are in line with all applicable regulations, policies,
guidelines
and procedures
.
Establishes, justifies, and
maintains
shelf life and retest intervals for GLP and GMP materials using ASA
P Prime modeling and/or stability study data.
Vendor management and oversight of workflow, progress and milestones at vendors
including early-stage CDMO selection and analytical scoping
Trouble-shooting
of analytical methods
Clearly and effectively communicate ideas and results, written and verbal, to technical and non-technical audiences
Author and/or review technical reports, test procedures, validation protocols and reports, and relevant sections of regulatory filings
E
nsure a smooth transfer of analytical technologies to contract sites
Keep
current with
developments in analytical methodologies and make recommendations for implementation of new methods/equipment.
Provide technical
assessment
during product acquisition due diligence as
required
Required
Knowledge, Skills, and Abil
ities Strong record of achievement in
analytical
development
Substantial direct
experience
small
molecule
analytical development, preferably in
a pharmaceutical
/biotech industry.
Strong experience in analytical sciences supporting research and early development programs (pre-DP0 to IND), with understanding of how strategies evolve into late-stage and commercial control
Direct experience with phase-appropriate method development, including minimal
viable
methods for early programs and progression to
validated
methods
Demonstrated experience
operating
in ambiguous early development environments, including limited material, evolving processes, and incomplete analytical understanding
Experience contributing to candidate
selection
, developability assessments, or early CMC strategy is highly desirable
Demonstrated technical
proficiency
in
analytical methodologies for
both
drug substance and drug product
Experience in regulatory requirements for pharmaceutical products
Experience in managing contract analytical organizations is highly
preferred.
Demonstrates potential for technical
proficiency
, creativity, collaboration with others, and independent thought. Strong teamwork skills
, including
ability
to lead and drive performance of cross-functional teams
.
Excellent written and verbal communication skills with
ability
to multi-task.
Demonstrated troubleshooting and
problem solving
skills
Demonstrated
track record
of delivering positive
results on a consistent basis.
Proven project management skills for technical programs
Experience in managing and
maintaining
budgets desirable
Required
/Preferred
Educatio
n and Licenses Advanced degree
BS
c
/MSc
in Chemistry, Pharm. Sci., Biochemistry, or related field
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
#LI-SP1 #LI-Remote 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. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here:
.
Sprachkenntnisse
- English
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