What are the responsibilities and job description for the Formulation Scientist II FL position at PL Developments?
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.
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.
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