Baxter
Hiring Research Associate III M Pharm, M Sc for Research and Development
Description
This
Research Associate III position will support stability activities of Medication
Delivery Team in the following day to day technical and operational
activities: stability planning for new
product development (NPD) and to sustain current product line (SPO), directing
R&D and commercial stability studies executed in Baxter facilities and at
Contract Research Organizations,
providing technical rationale for expiration dating and label storage
statement recommendations, preparing regulatory submissions, responding to
regulatory communications, and ensuring compliance related deliverables are
completed on schedule and per plan.
Specifically, this position is expected to:
Develop
stability study designs for new product development and sustaining product projects.
Contribute
to technical feasibility analysis of complex research and design concepts.
Evaluate
results relative to product requirements, definitions and/or program goals.
Independently
plan and execute a series of stability study designs and/or technical tasks
that may not be well-defined, have multiple variables, and require advanced
techniques within negotiated deadlines.
Play
a lead role in the evaluation, selection and adaptation of various techniques/
strategies, which accomplish business objectives such as quality and
cycle-time.
May
provide training and supervision to junior members within the discipline.
Routinely provide advice and assistance to team members regarding unique
problems.
Devise
new approaches to complex problems through adaptations and modifications of
standard technical principles. Incorporate new methods and technologies for
improving existing or new products/processes.
Maintain
current knowledge of relevant QSRs and other regulatory requirements, such as
the stability related ICH guidelines, for R&D (product development, design
and safety) to ensure compliance in all research, data collection and reporting
activities.
Displays
a solid understanding of theories/practices utilized by other disciplines
outside the primary area of expertise.
In
addition to having an in-depth knowledge and understanding of cGxP and related
regulations and guidance, is able to provide expert advice and/or is an active
participant in the generation, review, adoption and interpretation of such
regulations.
Develop
budgets and activity schedules of limited scope.
Maintain
focus on meeting both external and internal customer expectations.
Qualifications
Masters
degree in relevant scientific discipline (chemistry, pharmaceutical sciences –
M Pharm, M Sc) with 5-7 years experience or Masters degree with 3-5 years
experience or Ph D with 0-3 years experience.
Possess
relevant laboratory/technical, writing, and computer skills specific to
stability study design and development.
LIMs experience is a plus.
Utilize
a logical, methodical approach in independently solving problems, developing
solutions, and making recommendations.
Ability
to organize, assess and communicate complex information that engages the
audience.
Ability
to make decisions when provided with limited information and to make routine
decisions independently.
Ability
to articulate customer needs and incorporate into work product.
Contribute
to efforts beyond own scope of responsibilities to ensure project milestones
are met.
Ability
to design experiments and draw meaningful conclusions from lab data.
Experience
in working in global cross-functional teams and project management is a plus.
Ability
to adapt to changes and to work in a team environment.
Ability
to effectively mentor junior level associates.
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