Sr. Formulation Scientist at Puretek Corporation – Los Angeles, California

The Sr. Formulation Scientist (Solid and Liquid) performs batching of formulations and adjusts the products to meet specified criteria. Evaluates characteristics and performance of the batch against a specified standard. Monitors pilot and validation batches.

• Performs research studies on functions, characteristics, and applications of raw materials, dyes, fragrances, and colors communicating with the suppliers.
• Research for new ingredients and technology as assigned. Be able to summarize work into an appropriate format.
• Reviews, collates, and updates technical data from suppliers of raw materials used in the formulations.
• Write batch production protocol based on the clients’ formulation or based on reference standard product and then makes R&D batches based on assigned schedule.
• Performs batch color and flavor matching.
• Performs physical parameters and monitors short term lab stability to conform the final formulation.
• Prepares and submits samples for stability and customer approval.
• Tests physical parameters of stability samples against specifications.
• Batch adjustments as needed before making stability batches as well as validation batches.
• Reformulate existing products to improve the process to eliminate rework and to have better products. Provides support to production in process improvement and troubleshooting.
• Monitor all batch production protocols and stop production immediately and notify your direct supervisor if any deviations from the written production protocols are observed.
• Collaborates with team members of other groups/functions (formulators, analytical chemists, and manufacturing technicians) to facilitate the deliveries of drug products/active pharmaceutical ingredients and to solve analytical or production problems.
• Writes protocols, master manufacturing records, and product development report.
• Complies with cGMP & SOP and housekeeping policies.
• Maintains proper documentation of work; enters data, observations, and conclusions into Lab Notebooks accurately.
• Performs data entry, reports, and logs using the computer system.
• Helps oversee batches throughout manufacturing process (feasibility, pilot, validation, problem batches).
• Performs routine maintenance and calibration of laboratory instruments used in R&D (pH meters, refractive index, etc.).
• Maintains supplies necessary for designated areas.
• Assists in verifying labels against formulations and vice versa.
• Present research findings, technical reports, and project updates to senior management and other stakeholders to provide strategic insights and inform decision-making.
• Perform additional responsibilities as needed to support the team and achieve company goals.
• Fill out all quote paperwork properly with final formula, correct SPG, batch size etc.

• Excellent analytical and problem-solving skills, with the ability to interpret complex data.
• Proficiency in process optimization and scale-up from laboratory to production scale.
• Must be able to follow Company SOPs and cGMP guidelines

EDUCATION, EXPERIENCE AND LICENSURE

• B.S. Chemistry/B. S Pharmacy or equivalent education, training, and experience. Two years of R&D experience required.

TECHNICAL SKILLS

• Formulation Development
• Compatibility Testing
• Analytical Techniques
• Must have good visual/organoleptic alertness.
• Wet chemistry.
• Computer literate.

LANGUAGE SKILLS

• Must have excellent written and oral communication skills.

• Apply knowledge of Company policies and cGMPs in the manufacturing area
• Effectively prioritize routine and non-routine assignments
• Exercise judgment to escalate issues to senior management.
• Analyze information and apply logic and multiple scenarios.

Physical Demands and Work Environment The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential job functions.

• Work will be conducted in an FDA (Food and Drug Administration) and DEA (Drug Enforcement Agency) regulated pharmaceutical laboratory environment with risk of exposure to various chemicals and bacterial organisms associated with the manufacture of pharmaceuticals, nutritional supplements and cosmetics.
• Distractions such as noise from telephones, keyboards, talking, paging systems and equipment are common.
• Temperatures are regulated by facilities management and are not within the direct control of the individual.
• Position requires the incumbent to move from the work area to other areas of the company, including other offices, cubicles, warehouse and production areas, conference rooms and other offices in the same building or another building. The incumbent may be required to walk or drive his or her own vehicle to a second location a short distance away.
• Must be able to sit and/or stand for up to eight hours per day, lift and carry up to 20 lbs. with or without assistance, reach above shoulder height, bend, stoop, and crawl to retrieve items from under a desk or floor level cabinet or drawer; push and pull, use a computer keyboard and laboratory equipment throughout the workday while performing essential responsibilities.
• Exposure to standard chemicals used in an office environment is expected and includes but is not limited to toner, glue and liquid paper or whiteout.
• Exposure to chemicals, bacterial organisms and materials used in the manufacturing process of nutritional supplements, cosmetics, and prescription drugs and encountered in a laboratory and manufacturing environment.