biotechnology, leading development and execution of cross functional,
complex technical projects?
This is a contract role based in Dub Laoghaire, Dublin.
If you have the relevant experience, please forward your CV to **Apply
on the website** for review or call * **Apply
on the website** to discuss in confidence.
TECH TRANSFER LEAD - INTERMEDIATE - BIOTECH NPIS - 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 into
Ireland&# *;s leading aseptic manufacturing
plant.
This dedicated technical expert is accountable for leading the
management of cross functional activities required to successfully and
efficiently receive a portfolio of complex drug product manufacturing
processes.
The position will be accountable for success of the transfer project
from project initiation to the transfer, through regulatory
approval.
The position will execute processes on site, per the required
technology, characterization, and drug product specific knowledge that
will be transferred to the facility.
The lead should ensure that specifications are based on quality, cost
and time and will be defined for each product and facility.
This position provides leadership and expertise for operational,
scientific and engineering technology, including interface with
quality and regulatory policies.
The position will report to the Executive Director of Process
Development.
Moderate international travel might be required during the course of
the project.
Providing leadership to cross functional technology transfer team
which encompasses but is not limited to process/technology and
facility readiness including capital project implementation
Act as the responsible point contact from site for the transfer
project for drug product teams and Global Operations Teams
Management of timeline to meet the required product quality and
process performance
Responsible to deliver against organizational goals and project
milestones
Accountable for developing recommendations on potential paths forward
and the clear communication of those recommendations and their
rationale to project governance including risks of those paths and the
risks of alternate pathways
Accountable for devising mitigation strategies for risks of final
project pathway chosen
Escalate issues, recommendations, and/or unresolved decisions in a
professional and timely manner to the appropriate governance
Ensures that all appropriate groups are represented for decisions that
need to be made
Holds others responsible or answerable for their actions, for
exemplary job performance, and achieving business results
Full understanding of CMC Excellence business process related to
technology transfer
Partners with business process owners and Global Networks for business
processes related to technology transfer
Actively communicates across functions and sites and is a strong
collaborator with all the functional groups at the receiving site,
sending site and corporate functions.
REQUIREMENTS
Doctorate degree, Masters degree or Bachelor s degree & directly
related experience AND Managerial experience directly managing people
and/or leadership experience leading teams, projects, programs or
directing the allocation of resources.
Experience in biotechnology, leading development and execution of
cross functional, complex technical projects
Experience with molecule commercialization through commercial
licensure
Knowledge of development of commercial processes and process
characterization
Strong technical skills related to scale up
Thorough knowledge of GMP biotechnology manufacturing
Solid understanding and knowledge of cGMPs
Awareness and understanding of quality and regulatory industry trends,
policies and guidelines
Proven track record of advancement in an established, high performing
organization
Proven skills in building and maintaining productive relationships
with organizational partners such process development, manufacturing,
quality and regulatory affairs
Ability to lead effectively in an highly matrixed organization
Ability to make tough decisions
Ability to work with ambiguity
Excellent communication and management skills - Excellent project
management skills
Ability to make and drive decisions based on cross functional input
Strong understanding of validation of biopharmaceutical facilities,
equipment and process
Has the breadth of experience across disciplines to understand the
aspects of technology transfer to ask the right questions and
challenge appropriately
Ability to work with and communicate effectively with executive
management
Strong influencing and negotiation skills
PACKAGE
Contract role - Hourly rate € * - €**Apply
on the website** per hour
Minimum * month contract
We need : English (Good)
Type: Permanent
Payment: EUR 45 - 48 Per Hour
Category: Construction
