Job Description

Essential Duties and Responsibilities

NOTE: This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US without visa sponsorship or visa transfer.

• Conduct laboratory activities with limited supervision including for example analyzing raw materials, in-process materials and finished pharmaceutical products for quality, safety, purity, strength and identity using applicable methods or manufacturing drug product, following the cGMP, EH&S and other relevant guidelines of Corporate, FDA and other governing bodies.
• Independently set up and operate lab equipment, prepare reagents, solvents and solutions for analytical and formulation activities. Prepare and maintain accurate records in lab notebooks of all testing performed. Process analytical data on lab equipment such as HPLC/UPLC, enter data in spreadsheets and conduct routine calculations. Support the manufacture of inhalation drug product. Prepare samples for blend uniformity.
• Perform equipment qualification and calibrations as directed.
• Execute approved method transfer protocols.
• Assist in the training of other scientists.
• Perform other tasks as assigned.
• Participate in project activities and support project timelines and proactively contribute to meeting the team objectives. Communicates effectively with team members.
• Establish and maintain effective relationships with team members.
• Conduct lab work in accordance with SOPs & STPs; follow Corporate safety rules and procedures
• Comply with all Corporate guidelines and policies

Qualification Requirements

• Must be eligible to work in the United States without any visa sponsorship or visa transfer requirements. Not open to H1B holders.
• Must be willing to work 2nd shift.
• Must be able to work On-site in Weston, FL. (West of Ft. Lauderdale)
• Must have at least 2-3 years of experience of pharmaceutical industry R&D experience
• Must have strong HPLC and Empower experience.
• BSc in Chemistry, Pharmacy or related fields with 3-6 years of experience
• MSc in Chemistry, Pharmacy or related fields with 2+ years of experience in Pharmaceutical R&D
• Proven ability and/or experience with compendial test methods or pharmaceutical manufacturing equipment.
• Understanding of pharmaceutical equipment and computerized systems for operation and troubleshooting. Specific experience with analytical and/or process equipment used in laboratories such as HPLC, IR/FTIR, UV-Vis AA, powder blender etc.
• Knowledge and understanding of the FDA cGMP requirements as it applies to the Pharmaceutical industry.
• Effective English written and oral communication skills. Ability to write short technical documents such as memos, laboratory investigations, protocols and reports.

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