Apply for the post of Analytical Research Scientist I, Sun Pharma
Analytical Research Scientist I
The world’s largest pharmaceuticals market is also the biggest
market for Sun Pharmaceutical. We have been present in the US since 1996,
working with the country’s healthcare system with a focus on generics, branded
generics and over-the-counter (OTC) products. We are valued suppliers to the
largest wholesalers, distributors, warehousing and non-warehousing chain
drugstores and managed care providers. Being a vertically integrated company
with a global presence, we have the flexibility to develop and manufacture
products in the US as well as at other locations across the world. Our US
headquarters is located in Cranbury, New Jersey and we have manufacturing,
distribution and customer service teams at multiple locations across the
country.
IND123
Job Summary:
Search literature. Develop and validate analytical methods.
Design and execute laboratory experiments and interpret analytical data.
Perform analytical testing for new product development using instruments such
as HPLC, GC, LCMS, ICP-MS, Dissolution, Particle Size, and KF titrator.
Prepare SOPs, method of analysis and design development, release and stability
specification.
Must see
Essential Job Functions:
Ø Search literature,
develop, validate and transfer analytical methods for drug substance, drug
product and residual swabs (e.g. related compounds, assay, dissolution,
residual solvents, elemental impurities, etc.
Ø Able to design
experiment and execute and interpret analytical data.
Ø Design method transfer,
verification and validation protocols and author reports.
Ø Perform routine
analytical tests of pharmaceutical raw materials, in-process samples, finished
products, and stability samples using instrumentation such as HPLC,
UPLC, GC, UV/VIS, FTIR, dissolution apparatus, particle size analysis, etc.
Ø Perform characterization
of RLD and prepare report.
Ø Responsible for the
timely execution of lab analysis and related documentation.
Ø Concurrent documentation
of all raw data, record observations in templates/notebooks. Peer review of
analytical data.
Ø Interact with formulations
R&D group, understand and participate in progress of the project.
Ø Identify and
troubleshoot analytical problems with instrumentation, general chemistry, and
computer applications.
Ø Perform laboratory
investigations and write investigation reports using Trackwise software.
Ø Prepare CMC documents
necessary for ANDA/NDA submission.
Ø Mentor laboratory
technicians and junior chemists.\
Ø Adhere to safety, DEA
procedures, and department SOPs.
Ø Prepare and review
documents including method of analysis, specifications, SOPs, protocols
and reports.
Ø Perform other duties as
assigned.
Requirements and Qualifications:
Ø Bachelor of Science in Chemistry with a minimum ten years of experience or a Master of
Science and/or Ph.D in Chemistry with a minimum of eight years of
experience in pharmaceutical analytical laboratory with an active role in the
development and validation of chromatography, spectroscopy and wet chemistry
methods.
Ø Understanding of method
development using quality by design (QbD) approach.
Ø Strong analytical skills
with instruments such as HPLC, UPLC, GC, UV/VIS, FTIR, LCMS, ICP-Ms,
dissolution apparatus, particle size analysis, etc.
Ø Well versed with
Microsoft Office applications.
Ø Understanding of
FDA, ICH, and regulatory guidelines.
Ø Excellent knowledge of
cGMP and/or GLP practices and regulatory guidelines.
Physical Requirements:
Ø The physical demands
described here are representative of those that must be met by an employee to
successfully perform the essential functions of this job.
Ø Must be capable of
bending and lifting, moving and/or carrying up to approximately 50 pounds.
Ø Must have the ability
to wear applicable personal protective equipment utilized at the
site, including but not limited to respirators, safety glasses/goggles,
and safety shoes.
Ø Ability to navigate
office, lab, and/or plant floor working environments, stands, ambulates, and
reaches.
Ø Must have English language
fluency, both written and verbal, with the ability to communicate at all levels
within the organization.
Disclaimer
The preceding job description has been
designed to indicate the general nature and level of work performed by
employees within this classification. It is not designed to contain or be
interpreted as a comprehensive inventory of all duties, responsibilities and
qualifications required of employees as assigned to this job. Nothing herein
shall preclude the employer from changing these duties from time to time and
assigning comparable duties or other duties commensurate with the experience
and background of the incumbent(s).
We provide equal employment opportunities for
all current employees and applicants for employment. This policy means that no
one will be discriminated against because of race, religion, creed, color,
national origin, nationality, citizenship, ancestry, sex, age, marital status,
physical or mental disability, affectional or sexual orientation, military or
veteran status, generic predisposing characteristics or any other basis
prohibited by law.
Notice to Agency and Search Firm
Representatives:
Sun Pharmaceuticals Industries, Inc. (Sun) is
not accepting unsolicited resumes from agencies and/or search firms for this
job posting. Resumes submitted to any Sun employee by a third party agency
and/or search firm without a valid written & signed search agreement, will
become the sole property of Sun. No fee will be paid if a candidate is hired
for this position as a result of an unsolicited agency or search firm referral.
Thank you.
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