Senior Scientist II, Neurotoxin and Biologics Product Development
Company: AbbVie
Location: Irvine
Posted on: August 4, 2022
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Job Description:
JOB SUMMARY
Plans, directs, and executes product formulation & process
development activities in support of development of new products
intended for clinical trials and commercialization with focus on
neurotoxin and biologic drug products. Conducts research in the
area of formulation sciences in support of innovative product
development both for new biologic entities and life-cycle
management of marketed products.
The essential components of this position are in-depth
understanding of pharmaceutical formulation principles,
manufacturing process unit operations, global CMC regulatory
requirements as well as strong organizational skills to develop
formulations intended for clinical trials and commercialization.
Specifically,
Provide scientific and technical leadership for product formulation
development projects and in general, Pharmaceutical Sciences.
Applies the principles of quality by design (QbD) and statistical
process design/analysis to formulation and process development.
Demonstrate scientific excellence through scientific reports,
published articles in peer-reviewed journals, society
participation, regulatory filings, and/ or patents.
Represent department at CMC/Project Team meetings and work closely
with other Pharmaceutical Sciences departments, Toxicology,
Regulatory Affairs, Quality, Clinical Development and Marketing to
meet project timelines and objectives.
Apply current CMC regulatory requirements and guidance to support
global registration of new products.
Exhibit leadership skills that result in good performance and
career development of junior staff.
Keeps abreast of current developments in pharmaceutical technology,
leading edge technologies and regulatory affairs to contribute to
the technical base.
Have excellent communication (oral and written) and interpersonal
skills.
KEY DUTIES AND RESPONSIBILITIES
Primary focus: Plans, directs, and executes drug product
formulation & manufacturing process development activities in
support of development of new neurotoxin and biologic products
intended for clinical trials and commercialization. The incumbent
will design and execute formulation studies to optimize solution
conditions, such as pH, concentration, excipients, and other
parameters to sufficiently stabilize biologic molecules for use in
human clinical trials. This individual will propose phase
appropriate formulation strategies and drug product development
plans that align with overall project goals, that range from
supporting pre-clinical / phase 1 studies to developing products
for phase 3 / commercial launch. This incumbent will identify and
develop drug product manufacturing processes which may require bulk
biological drug substance freeze/thaw, liquid mixing, sterile
filtration, container filling, visual inspection, as well as
transportation / cold chain management. The incumbent will
technology transfer drug product manufacturing process to domestic
and international sites, including the identification, design, and
execution of at-scale process studies, as well as developing and
ensuring adherence to project schedules. The Senior Scientist I
will design and scale-up lyophilization processes for clinical and
commercial production, including cycle optimization, robustness
studies, and technology transfer. The incumbent will utilize ICH
Quality by Design methodologies such as risk assessments, Target
Product Profiles, and Critical Parameters to ensure appropriate
design space, control points, and in-process specifications are
established. The incumbent will author technical documents
including manufacturing records, formulation development &
technology transfer reports, and CMC sections of IND, IMPD, BLA
submissions. The Senior Scientist I, Neurotoxin & Biologics Product
Development will represent functional area at project team meetings
and work closely with cross-functional team members to develop the
overall CMC strategy, identify critical path activities and
timelines, as well as ensure coordinated project execution.
The position requires the individual to work with and in areas
requiring select agents and toxins access (i.e. Biosafety level 2
and biosafety level 3 laboratories). Access to and use of select
agents is regulated by federal policies. Therefore, the candidate
must conduct all work activities in compliance with AbbVie internal
and applicable regulatory requirements. AbbVie internal
requirements include compliance with ethics, environmental health
and safety, financial, human resources, and general business
policies, requirements, and objectives.
Provides scientific and technical leadership on one or more areas
of formulation development and dosage form design. Develops and
maintains a current in-depth knowledge of global CMC regulatory
submission requirements and GLP/GMP requirements. Review internal
and external technical documents, writes technical memos/reports,
patents, and scientific articles.
Represents department at CMC/project team meetings and work closely
with other Pharmaceutical Sciences departments, Toxicology,
Regulatory Affairs, Quality, Clinical Development and Marketing to
meet project timelines and objectives.
Performs supervisory duties including reviewing progress of
assignments against established project timelines, assistance on
daily work direction, problem solving and advice to junior staff to
enhance their work effectiveness in generating data, ensuring good
record keeping of all laboratory data, adherence to lab safety and
general staff development.
Education and Experience
This position requires a Ph.D. level education in pharmaceutical
sciences, biochemical/chemical engineering, biology, chemistry or
other related scientific with 4+ years of applicable experience or
a MS degree in pharmaceutical sciences, biochemical/chemical
engineering, biology, chemistry or other related scientific with
10+ years of applicable experience.
Must be able to operate as a functional area leader and utilize
knowledge of pharmaceutical science literature and experience to
guide decisions in complex situations. Knowledge of fundamental
applications of statistics is preferred.
PDN-ABV2209036
Keywords: AbbVie, Irvine , Senior Scientist II, Neurotoxin and Biologics Product Development, Other , Irvine, California
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