Sr Research Scientist-Formulations
Company: System One
Location: East Brunswick
Posted on: January 22, 2023
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Job Description:
Title: Sr. Research Scientist- Formulations Location: East
Brunswick, NJ area Type: Direct Hire Start Date: ASAP
Responsibilities:The R&D Sr. Scientist role is responsible for
performing formulation and process development studies, generating
documents, and scale up processes in support of ANDA or NDA
filings. Work across the development/scale up/technical transfer
projects. Work with subject matter experts, operation, and quality.
Responsible for development/validation/investigation report with
appropriate justifications, conclusion, and recommendations.Plan,
perform and direct development activities for new products. Drive
and monitor operational performance.Coordinate development
activities for each drug product with the respective
departments.Provide technical expertise and guidance for
troubleshooting & problem-solving activities related to process and
product investigations.Perform activities related to the
formulation and process scale-up activities. Identify & select the
appropriate ingredient required for use in new product development
and perform scientific review for specification of raw materials
and coordinate with suppliers as appropriate.Oversee manufacture of
products using production equipment, such as batches for ANDA
submissions, bioequivalence studies, and/or process
scale-up.Provide technical support of ongoing manufacturing for new
and currently produced products at the site.Work proactively with
QA, Manufacturing, and other groups and coordinate/manage
manufacture of registration/bio, validation, and initial commercial
batches.Review and prepare master manufacturing batch records and
process characterization protocols/ cleaning protocol using MACO
calculation.Develop components of the product development report,
process development report, and process parameter justification
reports.Use advanced mathematical tools to develop in accordance
with acceptable QbD.Maintain knowledge pertaining to cGMP documents
and guidance, other regulatory guidance and GMP SOPs and comply
with company standard operating procedures and currently accepted
practices to assure product quality, safety, and efficacy.Support
preparation of CMC documentation for the FDA and other
international regulatory submissions. Assist in getting ready for
pre-approval inspection (PAI). Requirements: B.S. in Pharmaceutical
Science or related discipline plus a minimum of 6 years'
experience.M.S. in Pharmaceutical Science with 4 years of
experience.Ph.D. in Pharmaceutical Science with 2 years of
experience.Background in formulations Indirect supervision,
mentoring, and negotiating skills.Experience having developed and
filled ANDA and NDAKnowledge of Technical techniques to evaluate
formulations, immediate and modified release dosage forms,
technology transfer methodologies, or advanced unit
operations.Knowledge of the overall drug development and
commercialization process from development, launch and through life
cycle managementWorking Excellent managerial skills; including
project management, problem-solving, written and verbal
communications, and organizational abilities.Hands-on formulation
research and development as well as formulation scale-up experience
is desired, knowledge of US FDA registration guidelines.Good team
player and self-starter, innovative and comfortable in a
multi-disciplinary team under defined timelines.
Keywords: System One, East Brunswick , Sr Research Scientist-Formulations, Other , East Brunswick, New Jersey
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