Chemist - Analytical Services - Pharma Raw Materials SOP's FDA exp

Position Title: Chemist - Analytical Services

Reports to: Director of Analytical Services

Location: Largo, FL

Department: Analytical Services

• You will perform routine analytical testing of pharmaceutical raw materials and finished products.
• You will assist in developing and validating analytical methods for active pharmaceutical drug substances and drug products.
• You will provide analytical input in support of product development to the formulation group.
• You will write and update SOPs, validation protocols, reports, test procedures, and specifications.
• You will maintain laboratory notebooks and lab instruments in compliance with internal SOPs and current IJSP, FDA guidance.
• You will communicate results in written and oral presentations.

Duties and Responsibilities:

• Ability to validate analytical methods for drug substance and drug products as per approved protocols.
• Execute analytical test procedures for the analysis of raw materials and finished products.
• Write and review analytical method validation protocols, reports, and technical documents.
• Write and update Analytical SOPs.
• Provide analytical support for new product development and participate in technical discussions with the formulation group, CRO and CMO.
• Capable of self-scheduling of work assignments.
• Assures right-first-time execution of methods and SOPs.
• Lead all analytical method transfer activities.
• Provide support for ordering and maintaining inventory of laboratory material and equipment.
• Participate in inter-department task teams.
• Perform all other duties as assigned, or as business needs require.

Education and Experience:

• BS Degree in chemistry, biology, or other related scientific discipline required.
• 3 to 5+ years of experience in the pharmaceutical industry and has extensive knowledge of chromatographic techniques.
• Experience with pharmaceutical laboratory equipment such as HPLCI I-JV, GCI Dissolution, IR, etc. is required.
• Experience in executing USP and EP test methodology is required.
• Ability to work effectively under pressure to meet deadlines.
• Demonstrate critical thinking ability with experience in conducting and writing laboratory investigations.
• Proficiency in word, excel, and pdf documents is a plus. Excellent attention to details
• Excellent verbal and written communication skills
• Good knowledge of FDA guidelines, ICH, and related guidelines
• Basic understanding of pharmaceutical drug development.
• Ability to manage timelines and priorities.
• Ability to establish and maintain good working relationships.

Travel as part of your job duties, travel between buildings is required on a routine basis. If applicable, you will be compensated at the current IRS mileage reimbursement rate.

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