Sr. Research Chemist
Company: RevBio, Inc.
Location: Lowell
Posted on: May 14, 2022
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Job Description:
Job Description Job Description: The Research Chemist II will be
responsible for planning and executing physical and chemical
characterization across multiple projects. This individual will be
responsible for method development, analysis of results and the
presentation of data to a cross functional team. The Research
Chemist II will actively interface with engineers, surgeons, and
the executive management team to characterize and develop medical
device products. This individual will perform analytical quality
testing for product characterization and product conformance and
may also interface with external collaborators and manage the data
acquired from them. Essential Duties and Responsibilities: Design
and conduct chemical, physical, and material characterization
testing and the development of related test methods; Conduct wet
lab-based testing including, but not limited to, the preparation of
samples for elution and homogeneity testing; Support the
development of various product formulations through the design and
execution of in vitro and in vivo testing; Conduct preliminary
leachable and extractable studies to assess product packaging
solutions; Develop methods for analyzing and optimizing drug
elution and conduct associated tests and studies; Support the
development of design specifications based on hazard and risk
assessments as well as user needs identified through market
research activities such as voice of customer interviews and
surveys; Prepare and support project design reviews and lead
discussions related to technical specifications; Develop
specifications for suppliers and oversee external testing in order
to meet internal development timelines and budgets; Perform testing
and report the resulting data on both raw material components and
final manufactured product using different analytical techniques
and instrumentation; Design studies to develop the most appropriate
analytical tests to ensure compliance to product specifications
documented within the RevBio Quality Management System; Develop
test protocols that are consistent with applicable international
and domestic test standards; Develop, write, and review Standard
Operating Procedures (SOPs); Develop test methods for quality
control documentation; Troubleshoot test methods and equipment as
needed; Calibrate analytical instrumentation on a scheduled basis
at the direction of the Quality Department; Think creatively,
problem solve, develop innovative solutions based on sound
engineering skills and statistical analyses; Perform other tasks as
may be required from time to time. Essential Education, Skills,
Environment Education and Work Experience: Master---s Degree in the
Sciences (Biochemistry or Chemistry); At a minimum 2-5 years of
medical device, pharmaceutical, or biotechnology experience is
required; Wet lab experience is a must with general physical,
thermal, and moisture characterization knowledge; Experience with
XRD, HPLC, NMR, FTIR, SEM, histology is highly preferred;
Experience with drug delivery development, drug release kinetics,
and pharmacokinetics is preferred; A demonstrated attention to
detail; Proficient in verbal and written communication; and A
demonstrated proficiency in understanding and applying design
controls and their development; Specialized Knowledge and Skills:
The ability to work in a multi-disciplinary team environment; The
ability to support project timelines independently or within a
project team; The ability to develop and maintain design control
documentation and project files; The ability to develop and perform
product testing, including, but not limited to, chemical, physical,
and material characterization testing; The internal motivation and
ability to assist driving a project to completion; The ability to
gain support from various resources both within and outside the
company; The ability to communicate effectively the status of a
project (or projects); The ability and willingness to receive
direction for all facets of management as it relates to Compliance
Regulations (i.e., FDA 21 CFR Parts 58 and 820 and ISO 13485); and
The willingness to assist in all necessary areas in order to
achieve overall success. Company Description RevBio, Inc., is a
medical device company engaged in the development and
commercialization of a patented, synthetic, injectable,
self-setting, and osteoconductive bone adhesive biomaterial called
Tetranite--. The company is initially developing this technology
for use in the dental and cranial market. However, the company is
also working to develop adhesive applications for the broader
orthopaedics market and additional applications in the animal
health market.
Keywords: RevBio, Inc., Lowell , Sr. Research Chemist, Other , Lowell, Massachusetts
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