Scientist/Sr. Scientist, Formulation and Process Development

3 weeks ago

Cranbury, United States Novelstar Pharmaceuticals Inc. Full time
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.


  • R&D Sr. Scientist

    2 weeks ago

    Cranbury, United States Medix™ Full time

    ResponsibilitiesDevelop and optimize analytical methods for various dosage forms (tablets, capsules, solutions, suspensions) independentlyMethods may include Assay, Impurities, Dissolution, and Residual Solvents analysisProvide analytical support to Formulation Development by conducting experiments (assay, impurity testing, dissolution)Utilize advanced...

  • R&D Sr. Scientist

    12 hours ago

    Cranbury, United States Medix™ Full time

    ResponsibilitiesDevelop and optimize analytical methods for various dosage forms (tablets, capsules, solutions, suspensions) independentlyMethods may include Assay, Impurities, Dissolution, and Residual Solvents analysisProvide analytical support to Formulation Development by conducting experiments (assay, impurity testing, dissolution)Utilize advanced...

  • Sr. Lead Clinical Scientist, Hematology

    1 month ago

    Cranbury, United States Rocket Pharmaceuticals Full time

    Overview Work at ROCKET PHARMA and help cure rare diseases! Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are...

  • Molecular Biologist/Gene Dev Scientist

    1 month ago

    Cranbury, New Jersey, United States Thermo Fisher Scientific Full time

    Job DescriptionPosition: Molecular Biologist/Gene Dev Specialist Scientist II Location: Cranbury, NJCOMPANY INFORMATION As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world...

  • Sr. Lead Clinical Scientist, Cardiovascular

    1 month ago

    Cranbury, United States Rocket Pharmaceuticals Full time

    Overview Work at ROCKET PHARMA and help cure rare diseases! Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are...

  • Principal Scientist of Crystallization R

    1 week ago

    Cranbury, United States Porton Pharma Solutions Ltd. Full time

    SUMMARY of RESPONSIBILITIESJob Title: Principal Scientist of Crystallization R & DPosition Reports to: VP of Cryallization R&DThis position is responsible for leading group or contributing individually to conduct solid form studies, crystallization process development, preformulation, crystallography particle engineering and/or coprocessing according to...

  • Principal Scientist of Crystallization R

    1 week ago

    Cranbury, United States Porton Pharma Solutions Ltd. Full time

    SUMMARY of RESPONSIBILITIESJob Title: Principal Scientist of Crystallization R & DPosition Reports to: VP of Cryallization R&DThis position is responsible for leading group or contributing individually to conduct solid form studies, crystallization process development, preformulation, crystallography particle engineering and/or coprocessing according to...

  • Scientist Ii, Protein Biology

    2 weeks ago

    Cranbury, United States Thermo Fisher Scientific Full time

    As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals...

  • Associate Scientist

    4 weeks ago

    Cranbury, United States Eastridge Full time

    Job DescriptionJob DescriptionEastridge Workforce Solutions is a leading provider of workforce management solutions, committed to connecting skilled professionals with meaningful career opportunities. Eastridge is hiring an Associate Scientist for a global pharmaceutical, biopharmaceutical, and medical device company. New grads with Biology, Chemistry, or...

  • Analytical Research and Development Sr. Scientist or Principal Scientist

    1 month ago

    Cranbury, United States Tulex Pharmaceuticals Inc. Full time

    Company DescriptionContact: fliu@tulexpharm.comTulex Pharmaceuticals is a specialty pharmaceutical company based in Cranbury, NJ. We are dedicated to developing and marketing innovative drug products for needy patients. Founded in 2014, our company has rapidly expanded from a Research and development entity to a fully functional cGMP facility that can...

  • Analytical Research and Development Sr. Scientist or Principal Scientist

    1 month ago

    Cranbury, United States Tulex Pharmaceuticals Inc. Full time

    Company DescriptionContact: fliu@tulexpharm.comTulex Pharmaceuticals is a specialty pharmaceutical company based in Cranbury, NJ. We are dedicated to developing and marketing innovative drug products for needy patients. Founded in 2014, our company has rapidly expanded from a Research and development entity to a fully functional cGMP facility that can...

  • Sr Statistical Programmer

    1 month ago

    Cranbury, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities: Develop, validate, and execute SAS programs for data extraction, transformation, and statistical analysis. Perform complex data manipulations, including merging, sorting, and aggregating large datasets. Generate tables, listings, and figures (TLFs) to summarize and present analytical results. Using SAS, perform SDTM, ADaM, and...

  • Senior Data Scientist

    2 weeks ago

    Cranbury, United States MJH Healthcare Holdings, LLC Full time

    Engage in identification, analysis, and interpretation of trends and patterns in complex data sets, to enhance visibility and accuracy on consumer behavior and to drive successful organizational decision–making. Perform data wrangling and data mining activities on web signup data from various platforms. Perform predictive analysis using various algorithms...

  • Senior Data Scientist

    6 days ago

    Cranbury, United States MJH Healthcare Holdings, LLC Full time

    Engage in identification, analysis, and interpretation of trends and patterns in complex data sets, to enhance visibility and accuracy on consumer behavior and to drive successful organizational decision–making. Perform data wrangling and data mining activities on web signup data from various platforms. Perform predictive analysis using various algorithms...

  • Senior Data Scientist

    2 weeks ago

    Cranbury, New Jersey, United States MJH Healthcare Holdings, LLC Full time

    Engage in identification, analysis, and interpretation of trends and patterns in complex data sets, to enhance visibility and accuracy on consumer behavior and to drive successful organizational decision–making. Perform data wrangling and data mining activities on web signup data from various platforms. Perform predictive analysis using various algorithms...

  • Gmp Chemical Operations Scientist

    3 weeks ago

    Cranbury, United States Porton USA, LLC Full time

    **Job description** Porton Pharma Solutions Ltd. is a leading global provider of comprehensive process R&D and manufacturing services to the pharmaceutical industry. We specialize in offering end-to-end solutions for small molecule APIs, dosage forms, and biologics. With a focus on innovation and customer satisfaction, we are committed to delivering...

  • Sr. Demand Planning Analyst

    4 weeks ago

    Cranbury, United States Snelling Staffing Services, LLC Full time

    Job DescriptionJob DescriptionDynamic Sr. Demand Planning Analyst (Temp to Hire) - Hybrid schedule ( 2 -3 days on site )The Sr. Demand Planning Analyst will facilitate product forecasting, demand planning, and logistics activities for related product types. Lead internal communications and S&OP processes to optimize inventory levels to maximize customer...

  • Manager/Sr. Manager, Quality Assurance

    5 days ago

    Cranbury, United States Novelstar Pharmaceuticals Inc. Full time

    Manager/Sr. Manager, Quality AssuranceLocations: Cranbury, NJFunctions: Quality Assurance and ComplianceJob descriptionNovelstar Pharmaceuticals Inc. (A Fosun Pharma Company) is hiring a Manager/Sr. Manager, Quality Assurance, to be located in Cranbury, NJ. If you are looking for a great pioneer opportunity to develop your career, be empowered to take charge...

  • Manager/Sr. Manager, Quality Assurance

    3 weeks ago

    Cranbury, United States Novelstar Pharmaceuticals Inc. Full time

    Manager/Sr. Manager, Quality AssuranceLocations: Cranbury, NJFunctions: Quality Assurance and ComplianceJob descriptionNovelstar Pharmaceuticals Inc. (A Fosun Pharma Company) is hiring a Manager/Sr. Manager, Quality Assurance, to be located in Cranbury, NJ. If you are looking for a great pioneer opportunity to develop your career, be empowered to take charge...

  • Associate Scientist I

    3 weeks ago

    Cranbury, United States Wapt Full time

    Overview: Plans and carries out _in vivo_ experiments and associated research assignments in rodents. Maintains the vivarium, labs, and program to AAALAC standards. Operates lab equipment including oxidizers, centrifuges, LS counters, and cage/tunnel washers. **Please note that this is a contingent/temp position and not eligible for benefits.** Schedule:...