Product Development Scientist

Kesin Pharma; Town of Florida (NY); On-site; USD 100,000 - 160,000; Full time

Job summary

Kesin Pharma is seeking a Product Development Scientist to lead development and scale-up of new drug products. Responsibilities include prototype development, stability studies, process design, and collaboration with Regulatory, QA, and Manufacturing to ensure FDA-compliant documentation and successful scale-up.

The role requires knowledge of FDA guidelines (QBD, GMP, GLP), experience in drug development, and ability to prepare and review development reports for FDA submission.

Qualifications

• M.S. degree with 2–4 years or B.S. with 4–6 years industrial experience in a scientific discipline.
• Experience in product development of oral liquids or semi-solid dosage forms preferred.
• Knowledge of FDA regulations, ANDA/IND/NDA processes and GMP.
• Ability to write and review development reports.

Responsibilities

• Conduct solubility/compatibility trials.
• Perform reverse engineering/de-formulation.
• Design experiments to prepare prototype formula.
• Conduct stability on lab-scale batches and interpret data.
• Prepare pilot scale batches to determine a suitable process for stability.
• Perform routine equipment calibrations/maintenance.
• Collaborate with Analytical R&D, QA, Regulatory, Clinical, Production and Purchasing for smooth development.
• Verify records meet FDA requirements and SOPs.

Skills

Excellent communication

FDA regulations knowledge

QBD knowledge

Good Manufacturing Practices

Education

M.S. degree with 2–4 years or B.S. with 4–6 years industrial experience

Job description

Job Title: Scientist, Product Development

Department: Product and Process Development (PPD)

Reports To: Management, Product Development

SUMMARY

The Product Development Scientist will assist the Management of Product Development in all aspects of new drug product and process development including but limited to – prototype development, lab stability, document creation, process design and optimization, pilot scale-up, assist the process development group in supervising clinical trial manufacturing material, Registration/exhibit batch manufacturing, and process optimization to full scale commercial batch size. Collaborate with other Scientific Affair Department (including Analytical R&D, Regulatory Affairs, Clinical and Project Management), commercial manufacturing and quality group. The right person will take a leadership role in development and scale up of product in collaboration with the Manufacturing group. He/She must know the FDA requirements for QBD, GMP, GLP, ANDA, IND/NDA applications, SUPAC guidelines. He/She must be able to write and review product development reports.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Conduct solubility / compatibility trials
• Perform reverse engineering / de-formulation
• Design experiments to prepare prototype formula
• Conduct stability on lab scale batches and interpret data to develop sound conclusions
• Prepare pilot scale batches to determine a suitable process which will yield stable product
• Perform routine equipment calibrations / maintenance
• Collaborate with other departments like Analytical R&D, Quality Assurance, Regulatory affairs, Clinical, Production, purchasing etc. to ensure smooth product development
• Assume responsibility in determining channels of exploration or methods of approach, development of recommendations, plans, steps, and techniques to be used for QBD based product development.
• Execute the developed plan with minimal supervision, evaluating and modifying procedures in consultation with management.
• Verifies that records of work performed are in accordance with FDA requirements and sound scientific standards.
• Maintain documents including lab notebooks in compliance with department SOPs.
• Prepares, reviews and approves documents prepared for submission to FDA including formula, manufacturing instructions, filling instructions, product development reports, QOS, stability protocols etc. for existing (old) products such as are generated by self or other departments.
• Assists the Operations team in manufacturing initial exhibition batches of new products to be used in stability and clinical studies.
• Assists the Operations team in trouble‑shooting technical problems affecting currently marketed products.
• Participates in Team Project Management System, departmental seminars, and in meetings with outside consultants as required.

• Keep current with new technology, methods, techniques and drug delivery systems by reading technical journals, attending trainings workshops etc.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, education, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

• M.S. degree with minimum 2-4 years or B.S degree with minimum 4-6 years industrial experience in a scientific discipline (i.e., Pharmacy) is required.
• Experience working in a product development capacity, especially in new and/or generic drug development.
• Experience in product development of oral liquids, semi-solid dosage form development preferred.
• Proven knowledge of QBD, scientific principles, manufacturing equipment, physical pharmacy.
• Knowledge of FDA regulations and requirements, ANDA, IND/NDA processes and Good Manufacturing Practices

CERTIFICATES, LICENSES, REGISTRATIONS

ØNone

LANGUAGE SKILLS

ØExcellent oral and written communication skills are required.

MATHEMATICAL SKILLS

ØSkills to do standard and/or complex pharmaceutical calculations are expected.

REASONING ABILITY

ØShould possess enthusiasm, initiative, and ability to solve technical problems.

WORK ENVIRONMENT

The work environment involves being on site (5 days a week, 40 hours a week) in laboratory using appropriate PPE and gowning procedures. The environment described here is representative of those an employee encounters while performing the essential functions of this job.

PHYSICAL DEMANDS

The physical demands of the job include ability to stand for 6-8 hours a day while performing experiments and ability to lift up to 10-20 pounds weight during manufacturing of pilot batches. Use of appropriate PPE including nose mask for extended periods of time may be required. Conditions described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.