Scientist job Islip New York
Scientist job Islip New York
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Scientist Job



Employer Name: Pharma company SpiderID: 8831950
Location: Islip, New York Date Posted: 7/25/2019
Wage: USD 80 - 100 k pa Category: Science/Research
Job Code:
Number Of Openings: 1

Job Description:
Operate as the subject matter expert (SME) on pre-formulation and formulation or process development or technology transfer or analytical sciences as applied to development, characterization, process analytical technologies (PAT) and incorporation of active pharmaceutical ingredients (APIs), excipients, packaging material and devices to develop finished products. Products may range from internal product development projects, products that are commercialized, products that are in-licensed from external entity or products that are co-developed with a development partner.
-- Conduct API, excipient, packaging or device characterization; excipient compatibility and forced degradation studies. Recommend stage appropriate acceptance criteria for vendor and regulatory specifications. Utilize relevant theoretical modeling and statistical tools, as required.
-- Develop robust lab-scale, pilot-scale and commercial-scale manufacturing process based on Quality by Design (QbD) principles using design of experiments (DOE). Recommend stage appropriate acceptance criteria. Utilize PAT where feasible. Utilize relevant statistical tools, as required.
-- Review and analyze relevant stability data from lab-scale, pilot-scale and commercial-scale, R&D and GMP stability studies by utilizing industry standard modeling and analysis tools including regression analysis for shelf-life prediction. Develop and implement strategies to control related substances, where applicable.


Job Requirements:
Operate as the subject matter expert (SME) on analytical methods for various internal and external projects. Independently develop, assess and/or verify and validate analytical test methods for APIs, excipients, packaging components, devices and drug products using industry standard methodologies including QbD principles for analytical methods; US FDA or EU guidanceā€™s and requirements; United States Pharmacopoeia (USP) guidelines; International Council for Harmonization (ICH) guidelines. Techniques may include standard tools like HPLC, UPLC, UV, GC, LC-MS, Viscometer, Karl-Fisher, IR, Particle size analyses, XRPD, DVS, Rheometer etc. to more specialized techniques such as LS-MS/MS, NMR, SS-NMR, Synchrotron etc.
-- Act as single-point technical contact for contract research organizations (CROs) and/or contract development and manufacturing organizations (CDMOs). Collaborate with project management (PM) function to lead execution of activities against approved plan.
-- Provide relevant subject matter expertise in collaboration with external partners in the form of participation in technical strategy discussions; consultation on technical studies; hands-on characterization and/or third-party interface (e.g., CROs, CDMOs etc.)


Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required: 3
Education Required: Masters
Overnight Travel: None
Vacation Time: 2 weeks / year


Company Profile:
Recruiting Firm

Contact Information:
Contact Name: Mandar K Company Type: Recruiter
Company: Talent Trackers
City: Atlanta
State: Georgia
Zip:

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