experience in a range of products and their associated manufacturing
sciences, technologies and analytical processes from within parenteral
fill-finish, or oral dosage forms and/or packaging
This is a contract role based in Dublin.
If you have the relevant experience, please forward your CV to **Apply
on the website** for review or call **Apply on the website** **Apply
on the website** to discuss in confidence.
PRODUCT LEAD PROCESS DEVELOPMENT MANAGER - BIOTECH - DUBLIN
JOB DESCRIPTION
Our client is a leading international Biotechnology company with a
state of the art aseptic manufacturing facility in Dun Laoighaire,
South Dublin.
The plant is one of the most dynamic in Ireland and is currently
undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience on Ireland&#**Apply
on the website**;s leading aseptic manufacturing plant.
The Product lead – Process Development will report to the Sr.
Manager Process Development in the Portfolio Management and Delivery
group and will be responsible for leading a cross-functional product
team in a matrix organisation to deliver new technologies and products
to site.
The successful candidate will have at least five years experience
within the pharmaceutical or biotech industry and will have
demonstrated program leadership skills.
Experience in a leadership role in a pharmaceutical or biotech
manufacturing facility that engages with site SMEs and managers, and
global functions
The ability to influence and lead cross functional teams to deliver to
ensure the smooth introduction of new products and the health of
existing products
The ability to work independently and identify risks and mitigation
pathways for new and existing products
A passion for continuous improvement applied to product and program
leadership
Act as the Product Health Steward and own product health for the
products in their brief through product governance and effective
product team leadership
Manage and develop product lifecycle management programs (multiple
products)
Assist in developing long term site product vision and strategy
Serve as main point of contact for global operations leads (GOLs) &
product delivery teams (PDTs)
Ensure that site’s needs are presented and prioritized appropriately
at site and global level
Build and manage the relationship with the product & process knowledge
SMEs at network and site level
Develop site product risks and implements plans to remediate risks
Make critical decisions and provide Process Transfer Technical
Leadership on the cross-functional Tech Transfer/NPI project team and
at Technology Development and Transfer Governance Forums
Engage at site product governance meetings i.e., Product Weekly Review
meeting, Site Ops meeting
Ensure changes to global product roadmap and contract books are fed
back to site through Product governance and prioritized appropriately
Influence key stakeholders on site and above site and protect site
strategy while meeting Network demands
Support new product/market launch
Compliance Related Tasks
Always ensure compliance to cGMP
Ensure safety & compliance standards are maintained to the highest
standards
Ensure financial compliance in line with Business & Financial guidance
Support a culture of personal responsibility within reporting
structure
Transversal working & collaborative style - must be able to work with
and maintain trust at all levels of the organization
Strong understanding of development, technical, manufacturing,
validation, quality and regulatory processes and Product Lifecycle
management
Strong understanding of current GMP regulations and industry practices
& trends
Demonstrated project/programme management skills
Excellent Communication Skills – continually communicating with
peers and to stakeholders both internally and globally.
Strong interpersonal skills
Strong leadership skills, especially with respect to collaboration,
influencing and co-ordination
Customer-focused decision-making skills.
Ability to prioritize complex projects
REQUIREMENTS
Technical Degree and/or Masters’ or equivalent
**Apply on the website** years in biopharma/pharma industry
A working technical knowledge in a range of products and their
associated manufacturing sciences, technologies and analytical
processes from within parenteral fill-finish, or oral dosage forms
and/or packaging
Ability to identify gaps/risks and put appropriate remediation plans
in place
Technical or program leadership experience
A proven track record in the ability to transfer goals and objectives
into measurable plans
Strong process and manufacturing background
PACKAGE
Contract role
Hourly Rate €**Apply on the website** - €**Apply on the website**
per hour
Minimum **Apply on the website** month contract
We need : English (Good)
Type: Permanent
Payment: EUR 55 - 65 Per Hour
Category: Construction
