Research Scientist II - Biologics Drug Product & Device Development

Profile

Specific Responsibilities
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Sciences, Inc. is a research-based biopharmaceutical company founded in 1987.
Together we deliver life-saving therapies to patients in need. With the
commitment and drive you bring to the workplace every day, you will be part of
a team that is changing the world and helping millions of people live
healthier, more fulfilling lives. Our worldwide staff is a close community
where you can see the tangible results of your contributions, where every
individual matters, and everyone has a chance to enhance their skills through
ongoing development. Our scientific focus has resulted in marketed products
that are benefiting hundreds of thousands of people, a pipeline of late-stage
drug candidates, and unmatched patient access programs to ensure medications
are available to those who could otherwise not afford them. By joining **MEMBERS ONLY**SIGN UP NOW***.,
you will further our mission to address unmet medical needs and improve life by
advancing the care of patients with life-threatening diseases.
**MEMBERS ONLY**SIGN UP NOW***. has an
opportunity in the Biologics Drug Product and Device Development
department at our facility in Oceanside, California. We are seeking a motivated,
team-oriented individual with scientific expertise in biologics drug product
formulation development, vial and syringe fill / finish process development, as
well as troubleshooting pre-clinical and clinical drug product manufacturing operations
related to recombinant proteins. Reporting to a Senior Research Scientist, you
will have the opportunity to participate in project teams developing biologic
molecules for both early and late stage clinical development.
Specific
Responsibilities and Skills Required:
We are seeking candidates with a thorough understanding of scientific
approaches to developing biologic protein formulations, including experience
in design and execution of screening studies evaluating effects of pH,
buffers, stabilizers, surfactants, etc. on biochemical and biophysical
stability, for frozen, refrigerated liquid, and lyophilized formulations, for
early and late stage molecules.
The candidate will be
expected to provide scientific leadership to the development of drug product
formulations and/or processes, and demonstrate hands-on technical expertise/leadership
in the laboratory by overseeing or delegating experimental/project
responsibilities. The individual will be responsible for: new formulation evaluations and optimization, defining new formulation
platforms, writing/reviewing development summary reports, and authoring Regulatory
submissions.
The candidate will oversee
or execute the R&D; stability testing of final dosage forms, characterize
degradation pathways and products, conduct compatibility studies
with drug-delivery devices (pre-filled syringes, auto-injecting systems, etc.)
and other container closure systems.
The successful candidate
will be responsible for conducting biochemical and biophysical characterization
of proteins and their degradation products with a focus on evaluating the
stability and comparability of molecules via methods such as HPLC, capillary electrophoresis, particulates
(flow imaging, light obscuration, RMM), as well other physical and spectroscopy
techniques.
As necessary, the
candidate will partner with the Analytical Development group to provide scientific
feedback on the development of stability indicating assays.
May lead the Drug Product
technology transfer from process development to clinical and commercial
manufacturing sites, serve as the technical representative during fill/finish
operations and participate in technical troubleshooting. Assist in technical
review of batch records for lot release and CMO summary reports
An understanding of the approach and
demonstrated experience developing, characterizing, and troubleshooting, a
variety of formulation and drug product manufacturing unit operations, such as
bulk storage freezing / thawing, compounding / mixing, sterile filtration, vial
and syringe filling, lyophilization, as well as manual and automated visual
inspection for early and late stage molecules.
Experience
conduction drug product manufacturing risk assessments to identify critical
process parameters (CPPs), as well as designing and executing process
characterization studies to define CPP targets and ranges for manufacturing
unit operations as part of a Quality by Design approach to process development.
Experience with Regulatory
Filings including authoring relevant sections of INDs/CTDs, as well as response
questions, is desired.
The applicant should be an effective
communicator of ideas and results to team members within cross-functional
roles/departments. **MEMBERS ONLY**SIGN UP NOW***. supports a highly collaborative environment where
willingness and ability to communicate and work effectively with individuals
across project teams is essential.
Candidates should be self-motivated
and organized, familiar with the relevant scientific literature, and enjoy
scientific investigation and thinking, proactively identify issues and develop
solutions. As
necessary, the candidate will also independently champion the evaluation and
development of new technologies.
Essential Duties and Job Functions
Responsible for conducting scientific research for the development of drug candidates or the research support of marketed drugs.
Works in collaboration with more senior scientists or scientific directors to advance the development of state-of-the-art techniques to characterize substances, assays and tools.
Works on moderately complex problems where analysis of situations or data requires evaluation of intangible variables, requiring regular use of ingenuity and creativity.
Advises Research Associates or members of project teams in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.
Makes contributions to scientific literature and conferences through publication and presentation of research results.
Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and strategy.
Knowledge, Experience and Skills
3 years of experience with PhD in a related scientific discipline.

BS or MS degree with extensive industry experience.
As an equal opportunity employer, **MEMBERS ONLY**SIGN UP NOW***. Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without regard to race, color, religion, national origin, gender, age, sexual orientation, disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ****
for assistance.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’
poster.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
**MEMBERS ONLY**SIGN UP NOW***. provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
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