on the website**)
* Biopharmaceutical Lab Manager* - Athlone, Ireland (Joining bonus
?**Apply on the website**)
* PPD GMP Laboratory Athlone, Ireland is currently in construction
stage for a large extension that will see us double our footprint and
expand our Cell & Gene therapy testing capabilities in Ireland in the
next three years.
* One of the largest Labs of its kind in Europe, o ur GMP laboratory
based in Athlone, Ireland offers fully integrated solutions for
product development and analytical development, including analytical
testing services in method development, method validation, method
transfer, release and stability studies. Our highly qualified GMP lab
staff work across Biopharm, Cell / Molecular Biology, Small Molecule
and Inhalation laboratory groups.
* We are currently looking for Laboratory Managers to join our Teams!!
* The role of Laboratory Manager is to provide leadership and support
to Group Leaders, Scientists, and Project Managers in laboratory
operations with tasks such as scheduling, resource management,
technical and compliance related issues. They will plan, direct and
implement improvements in systems, processes and procedures to
increase efficiency, productivity and quality in the laboratory.
They will assist the Site management in strategic planning, business
development and expansion initiatives.
* Key responsibilities
* * Manages/directs work responsibilities of group leaders as well as
prioritize projects and resources
* Provides leadership and support to multiple employees in a positive
and encouraging manner to motivate the team with drive, energy and
enthusiasm
* Reviews data for technical quality and compliance to protocols,
methods and SOPs. Reviews and approves laboratory investigation,
deviations, and QA facility and data audits. Leads client and
regulatory audits
* Reviews and approves study protocols, project status reports, final
study reports and other project related technical documentation
* Interacts with clients and business development on requests for
proposals and project definition, Prepares, reviews, and approves bids
and proposals, scope of work and pricing and negotiates with clients
on timelines and pricing
* Prepares and updates revenue projection reports and timesheet
reports for revenue recognition and billing, evaluates resource
utilization reports and project profitability
* Assists upper management in strategic planning, budgeting, new
capabilities development, makes recommendations on process improvement
and fosters a GMP culture
* QUALIFICATIONS:
* * Experience and
QUALIFICATIONS:
* * Educated to a Bachelor&#**Apply on the website**;s Degree level in
a relevant area, ie chemistry, biochemistry.
* **Apply on the website**+ years&#**Apply on the website**;
experience in the Biotech, Pharmaceutical or Analytical Contract
Laboratory industries within Stability, QC or analytical development
departments.
* Experience in Cell and Gene Therapy is an advantage.
* 5+ years&#**Apply on the website**; experience managing teams of
technical staff, including Lab supervisors, team Leaders / Lab
leaders, with proven leadership record and evidence of team
development.
* Demonstrated strategic planning skills.
* Knowledge of budgeting, forecasting and fiscal management.
* Full understanding of cGMP requirements, client SOPs, ICH
guidelines, EP and USP requirements and EMA and FDA guidance&#**Apply
on the website**;s.
* Strong ability to perform root cause analysis and implement
effective CAPA.
* Knowledge and experience of a wide range of techniques, HPLC, UPLC,
Electrophoresis (CE, iCE, SDS-PAGE), ELISA, spectrophotometry with
proven technical troubleshooting and problem-solving abilities.
* Knowledge and experience in Cell based assays, qPCR, ddPCR is an
advantage.
* Experience in drug product development, manufacturing and filing
will be valued.
As well as being rewarded a competitive salary, we have an extensive
benefits package based around the health and well-being of our
employees. We have a flexible working culture , where PPD truly value
a work-life balance. We&#**Apply on the website**;ve grown sustainably
year on year but continue to offer a collaborative environment, with
teams of colleagues eager to share expertise and have fun together.
We are a global organisation but with a local feel.
* Joining Bonus
* Pension scheme
* Annual Leave **Apply on the website** days
* Medical Health care cover
* Life Insurance
* Relocation package can be considered for candidates outside Ireland
* We have a strong will to win - We earn our customer&#**Apply on the
website**;s trust - We are gamechangers - We do the right thing
-We are one PPD -
* If you resonate with our five principles above, and ultimately wish
to accelerate the delivery of safe and effective therapeutics for some
of the world&#**Apply on the website**;s most urgent health needs,
then please submit your application - we&#**Apply on the website**;d
love to hear from you.
#LI-MG1 Position: ?Biopharmaceutical Lab Manager ?Joining bonus ?**Apply
on the website**)
* Biopharmaceutical Lab Manager* - Athlone, Ireland (Joining bonus
?**Apply on the website**)
* PPD GMP Laboratory Athlone, Ireland is currently in construction
stage for a large extension that will see us double our footprint and
expand our Cell & Gene therapy testing capabilities in Ireland in the
next three years.
* One of the largest Labs of its kind in Europe, o ur GMP laboratory
based in Athlone, Ireland offers fully integrated solutions for
product development and analytical development, including analytical
testing services in method development, method validation, method
transfer, release and stability studies. Our highly qualified GMP lab
staff work across Biopharm, Cell / Molecular Biology, Small Molecule
and Inhalation laboratory groups.
* We are currently looking for Laboratory Managers to join our Teams!!
* The role of Laboratory Manager is to provide leadership and support
to Group Leaders, Scientists, and Project Managers in laboratory
operations with tasks such as scheduling, resource management,
technical and compliance related issues. They will plan, direct and
implement improvements in systems, processes and procedures to
increase efficiency, productivity and quality in the laboratory.
They will assist the Site management in strategic planning, business
development and expansion initiatives.
* Key responsibilities
* * Manages/directs work responsibilities of group leaders as well as
prioritize projects and resources
* Provides leadership and support to multiple employees in a positive
and encouraging manner to motivate the team with drive, energy and
enthusiasm
* Reviews data for technical quality and compliance to protocols,
methods and SOPs. Reviews and approves laboratory investigation,
deviations, and QA facility and data audits. Leads client and
regulatory audits
* Reviews and approves study protocols, project status reports, final
study reports and other project related technical documentation
* Interacts with clients and business development on requests for
proposals and project definition, Prepares, reviews, and approves bids
and proposals, scope of work and pricing and negotiates with clients
on timelines and pricing
* Prepares and updates revenue projection reports and timesheet
reports for revenue recognition and billing, evaluates resource
utilization reports and project profitability
* Assists upper management in strategic planning, budgeting, new
capabilities development, makes recommendations on process improvement
and fosters a GMP culture
* QUALIFICATIONS:
* * Experience and
QUALIFICATIONS:
* * Educated to a Bachelor&#**Apply on the website**;s Degree level in
a relevant area, ie chemistry, biochemistry.
* **Apply on the website**+ years&#**Apply on the website**;
experience in the Biotech, Pharmaceutical or Analytical Contract
Laboratory industries within Stability, QC or analytical development
departments.
* Experience in Cell and Gene Therapy is an advantage.
* 5+ years&#**Apply on the website**; experience managing teams of
technical staff, including Lab supervisors, team Leaders / Lab
leaders, with proven leadership record and evidence of team
development.
* Demonstrated strategic planning skills.
* Knowledge of budgeting, forecasting and fiscal management.
* Full understanding of cGMP requirements, client SOPs, ICH
guidelines, EP and USP requirements and EMA and FDA guidance&#**Apply
on the website**;s.
* Strong ability to perform root cause analysis and implement
effective CAPA.
* Knowledge and experience of a wide range of techniques, HPLC, UPLC,
Electrophoresis (CE, iCE, SDS-PAGE), ELISA, spectrophotometry with
proven technical troubleshooting and problem-solving abilities.
* Knowledge and experience in Cell based assays, qPCR, ddPCR is an
advantage.
* Experience in drug product development, manufacturing and filing
will be valued.
As well as being rewarded a competitive salary, we have an extensive
benefits package based around the health and well-being of our
employees. We have a flexible working culture , where PPD truly value
a work-life balance. We&#**Apply on the website**;ve grown sustainably
year on year but continue to offer a collaborative environment, with
teams of colleagues eager to share expertise and have fun together.
We are a global organisation but with a local feel.
* Joining Bonus
* Pension scheme
* Annual Leave **Apply on the website** days
* Medical Health care cover
* Life Insurance
* Relocation package can be considered for candidates outside Ireland
* We have a strong will to win - We earn our customer&#**Apply on the
website**;s trust - We are gamechangers - We do the right thing
-We are one PPD -
* If you resonate with our five principles above, and ultimately wish
to accelerate the delivery of safe and effective therapeutics for some
of the world&#**Apply on the website**;s most urgent health needs,
then please submit your application - we&#**Apply on the website**;d
love to hear from you.
#LI-MG1
We need : English (Good)
Type: Permanent
Payment:
Category: Others
