Formulation Scientist II FL

JOB QUALIFICATIONS:

• Master’s degree in Pharmaceutics, Industrial Pharmacy, Chemistry or related discipline with 2 - 4 years of experience or bachelor’s degree with 4 – 6 years of experience in Drug Product Development of oral liquid dosage form (Solutions, IR Suspensions, ER Suspensions, Powder for Oral Suspension etc.).
• Hands-on experience of pharmaceutical equipment and troubleshooting skills.
• Requires good understanding of cGMP related to pharmaceutical manufacturing.
• Ability in mathematical calculations for formulation compositions, and data analysis and presentation.
• Possess excellent verbal, written, and interpersonal skills.
• Demonstrate skill for problem solving, prioritizing objectives from multiple projects, and meeting the scheduled timelines while maintaining the attention to details.
• Self-motivated with the ability to work under pressure to meet deadlines
• Able to travel as needed

POSITION RESPONSIBILITIES:

• Design and perform experiments to develop robust formulations and manufacturing processes.
• Evaluate characteristics and attributes of raw materials being used.
• Understand the impact of processing parameters on the product quality attributes.
• Optimize existing formula and manufacturing process, if needed.
• Review industry guidance, ICH guidance and compendial requirements as needed.
• Communicate with regulatory team to establish regulatory strategy for each product assigned.
• Coordinate with Analytical Department to complete testing as per priority, collect data upon testing completion and analyze to determine path forward.
• Design sampling and testing plan for experimental scale-up batch to optimize processing parameters.
• Write batch records, protocols, development reports and route electronically for final approval.
• Oversee batches being manufactured in manufacturing facility such as exhibit/submission batches, clinical trial batches and process scale-up studies to ensure successful execution in timely manner.
• Identify appropriate packaging components to ensure product stability. Design stability study.
• Support finalizing specifications for finished products and packaging components.
• Design and initiate stability studies on selected batches of drug products.
• Support qualification, calibration, and maintenance of R&D instruments/equipment, if required.
• Support manufacturing of commercial products, if required.
• Perform other tasks as assigned by the supervisor based on business need.

PHYSICAL REQUIREMENTS:

• Work safely and follow all OSHA regulations and company safety policies and procedures
• Exposure to vitamins, minerals, herbal, and OTC products disagreeable odors, high-noise levels, constantly bending, lifting and standing for long periods. No allergies
• Ability to sit, stand, and walk for extended periods during laboratory work and meetings.
• Manual dexterity to handle laboratory equipment, glassware, and small tools with precision.
• Capacity to lift and carry materials weighing up to [specify weight, e.g., 25 lbs], such as chemical containers or lab supplies.
• Tolerance for extended use of personal protective equipment (PPE), including safety glasses, gloves, and lab coats.
• Visual acuity to read fine print, observe detailed work in formulations, and monitor computer screens.
• Ability to work in temperature-controlled environments such as labs and cleanrooms, which may vary between slightly cool and warm.
• Willingness to handle and potentially transport hazardous chemicals, adhering to all safety protocols.