Scientist/Sr. Scientist, Formulation and Process Development

Locations: Cranbury, NJ

Functions: R&D Formulation and process development, tech transfer and process validations

Job description

Novelstar Pharmaceuticals Inc. is hiring a Scientist/Sr. Scientist, Formulation and Process development, to be located in Cranbury, NJ. If you are looking for a great pioneer opportunity to develop your career, be empowered to take charge of your future at Novelstar.

Novelstar Pharmaceuticals Inc. is a Fosun Pharmaceutical (Group) Co., Ltd) company. Our mission is innovations, develop novel pharmaceutical drug products (NDA), deliver high quality generic products (ANDA) and provide service to pharmaceutical industries. Our vision is to be a robust growth innovation leader and partner in global healthcare and enhance people`s lives.

This role will serve as a contributor in formulation and process development of NDA/ANDA products with QbD concept for various pharmaceutical dosage forms, primarily oral solids, semisolids, and liquids, injectable drug delivery systems, experience with nanoparticle is a big plus.  This role will support the product developments in R&D division and Fosun Pharma’s global subsidiaries; responsible for the CMC development of primarily small molecules drug products; co-ordinates with other departments to the company goals for US and global markets.

Key Responsibilities include but are not limited to:

·        Responsible for developing pharmaceutical products leading to successful NDA/ANDA filings and approval in a timely manner through internal or external sources.

·        Serving as primary author of CMC sections related product development, notebooks, specifications, and stability in NDAs, ANDA and other regulatory submissions.

·        Serving as primary author of product development reports, technical report/summaries independently, include but not limited to:

-         Generating accurate, reliable data by following established procedures and practices for product development, records, tabulate, summarize and reporting results.

-         Interpreting and displaying data in a clear and concise manner, thoroughly and accurately documenting all formulation and development work.

-         Preparing technical reports that provide a comprehensive history of product development activities.

-         Ensuring all regulatory documents in compliance with SOPs, FDA Regulations, and cGMP policy where applicable.

·        Supporting pilot plant cGMP qualification and maintenance including developing SOPs and technical documents to support IQ/OQ/PQ process of equipment and documentations. 

·        Designing and hands-on formulation and process development for various drug delivery systems (oral solids, semisolids, liquid, and injectables) based on QbD from project initiation to commercialization by following appropriate GMP regulations and safety requirements.

·        Preparing product manufacturing batch records and protocols for different product development stages, including from R&D prototype to scale up by following related SOPs and procedures, ensuring the detailed record and data keeping.

·        Responsible for coordinating the activities of characterization of APIs, excipients and in process products; analysis of in-process samples or in-process products based on protocols and QbD concept, preparing various formulation samples to support cross-functional programs as needs.

·        Reviewing and analyzing patents on RLD and providing the technical approaches for ANDA product development without interfering with the innovator patents.

·        Knowledge of Good Manufacturing Practices. Understands change controls, deviations and CAPAs (Corrective and preventive action).

• Maintaining formulation development notebook document work.
• Maintaining compliance with cGMP, SOPs and DEA regulations.

·        Interfacing with Key partners include R&D leaders, CMC-Leaders, supply chain platform leaders, and Quality Assurance.

Qualifications and Requirement

·        Master or Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or related discipline, experience in NDA (ex. 505(b) (2))/ANDA pharmaceutical product development from “End to End” is a plus.

·        In-depth theoretical and hands on experience in pharmaceutical technologies and equipment for various dosage forms (oral solids, topicals, semisolids, liquids, softgels and parenteral dosage forms etc.), especially focused on modified release delivery systems and water insoluble APIs.

·        Experience with nanoparticle oral or injectable drug delivery systems is a big plus. 

·        Excellent interpersonal skills demonstrating effectiveness as a team player on multidisciplinary teams resourced in a flexible and global environment is required.

·        Demonstrate ability to be self-motivated with an inherent winning can-do attitude.

·        Excellent communications and presentation skills – written and verbal; fluent in English.

·        Fluent with all Microsoft office computer applications (i.e. Word, Excel, PowerPoint, etc.)

·        Flexible working hours. For Company priority projects, the employee may work after hours and weekend.

Knowledge and Skills

·        Strong problem-solving ability; ability to predict issues and identify solutions.

·        Demonstrated ability for innovative and breaking through.

·        Excellent organizational skills: Proactive, management of multiple tasks of varied complexity simultaneously.

·        Proven technical writing skills and primary author in pharmaceutical product development reports for FDA submissions or scientific publications.

·        Negotiation and strong persuasive abilities, diplomacy, and positive influencing abilities.

Compensation:

Commensurate with experience, medical/dental/vision insurances, disability and life insurance,  holidays, and paid time off and 401k.

DISCLAIMER: The above job description is intended to describe the general nature and level of work being performed by employees assigned to this job. It is not designed to capture or illustrate a comprehensive list of all responsibilities, duties, and skills required of employees assigned to this job.