MFG Chemist job HAUPPAUGE New York
MFG Chemist  job HAUPPAUGE New York
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MFG Chemist Job

Employer Name: ScieGen Pharmaceuticals, Inc. SpiderID: 10432295
Location: HAUPPAUGE, New York Date Posted: 4/26/2021
Wage: Category: Medical/Health
Job Code:

Job Description:

MFG Chemist needed to perform the following duties :

Work under the guidance and close direction of our Sr. Scientist-Manufacturing to research and develop all activities relating to the manufacturing of various dosage forms by performing scientific analysis and conducting laboratory tests/experiments as instructed;
Follow guidance of senior chemists/scientists to analyze and execute commercial and validation batches of solid dosages forms by collecting/reviewing scientific data and conducting lab experiments/analysis on such data in a group setting by following established scientific guidelines;
Work under the guidance of senior chemists/scientists in the product development department to execute Bio-batches (ANDA) and validation batches and to develop pharmaceutical dosage forms using scientific techniques will include collecting and quantitatively & qualitatively analyzing scientific data generated from the manufacturing of these bio-batches/validation batches as per guidelines and instructions from experienced team members;
Assist senior chemists/scientists to develop testing procedures in compliance with regulatory requirements by following established regulatory/scientific guidelines and instructions from senior scientists;
Follow established guidelines/plans to ensure effective implementation of quality management system as per cGMP and regulatory requirements at all levels of manufacturing by collecting/researching/analyzing scientific data/reports, recording scientific evidence/results from development/manufacturing activities etc. as directed by senior scientific professionals;
Perform execution of Installation Qualification (IQ),Operational Qualification (OP) and performance Qualification (PQ) of production equipment as per guidelines established by senior team members;
Compile documentation involved in execution of commercial & validation batches & draft documents for regulatory audits, ANDA submissions to US FDA and cGMP documentation with reference to manufacturing department for review and approval by department managers;
Analyze scientific data generated during execution of production activity such as batch manufacturing records and validation protocols and prepare documents for review, corrections and approval by senior team members;
Coordinate with multiple departments and assist senior chemists/scientists in providing them with scientific data/reports & inputs/requirements so that all teams can effectively plan for cost-effective and compliant inventory such as active pharmaceutical ingredients, chemical compounds, excipients etc.;
Approximately 85% of the time will be spent in developing, improving and validating manufacturing methods for active pharmaceutical ingredients and dosage forms while developing testing procedures and performing quality control activities under close supervision and guidance of experienced chemists/scientists in our scientific manufacturing team. Approximately 15% of the work will involve assisting in preparing technical reports/papers, and conferring/interacting with scientists and maintaining ICH guidelines and US FDA regulations.

Bachelor's Degree is required in Chemistry or Organic Chemistry

Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required: Bachelors
Overnight Travel:
Vacation Time:

Contact Information:
Contact Name: ScieGen Pharmaceuticals, Inc. Company Type:
State: New York
Zip: 11788

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