The position is for Associate Scientist – Analytical Chemistry
Location: Central Islip, New York, USA
Experience: 1-4 Years
Salary: As per Industry Standards.
Job Description
SCOPE
The content and statements documented in this job description are designed to describe the general nature and level of work as well as provide a basic understanding of the role, responsibilities, and expectations of the person assigned to perform the job. This job description is not designed to provide an exact or exhaustive list of all job duties, tasks, skills, and qualifications. The intent of this job description is to be representative of the knowledge, skills, and abilities needed to satisfactorily perform the essential functions of the position satisfactorily and in accordance with the established performance expectations.
PURPOSE
The Associate Scientist position is an individual contributor role and reports to the Research & Development (R&D) Manager for the Client at New York. The job duties for this position include but are not limited to the following:
- Under supervision designing and conducting laboratory scale pre-formulation, formulation and process development experiments to develop formulations and products.
- Under supervision developing independently or participating in the development and validation of analytical methods.
- Conducting characterization of samples from pre-formulation, formulation and process development studies.
- Conducting assessment of various unit processes during manufacturing process to recommend acceptance criteria.
- Conducting development and optimization of manufacturing processes at laboratory scale by optimizing various parameters under Quality by Design paradigm.
- Conducting manufacture of lab-scale and pilot-scale batches.
- Conducting statistical analysis of process development data to recommend acceptance criteria for various unit processes
- Reviewing analytical characterization data including data from pre-formulation, formulation, process development and stability studies during the course of product development.
- Leading scale-up and technology transfer of process from R&D to Commercial Operations.
- Leading and conducting process development, process verifications, process validations, site and equipment qualifications in collaboration with stakeholders.
- Drafting technical documents (protocols, reports, technical memorandums).
- Investigating incidents and deviations during the manufacturing process, and if required, conducts investigations, as per standard operating procedures (SOPs).
- Working with the change control system for the technical services department.
- Maintaining effective communication and coordinating activities with multi-functional stakeholders.
- Drafting and maintaining of electronic copies of all approved mater formula cards utilized in the manufacturing of products and maintaining written record of all activity associated with approvals of electronic copies.
- Understanding and following all policies and procedures as outlined in pertinent SOPs.
EDUCATION AND EXPERIENCE
Masters’ degree with 1-4 years of experience in relevant discipline.
In-depth understanding of physical pharmacy, physical chemistry, thermodynamics, analytical chemistry tools, chemical reaction kinetics is a must.
Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices.
Strong command over written and verbal English is a must.
Must be proficient in computer skills and software applications such as Microsoft Office tools.
Must communicate clearly and concisely across levels, both orally and in written.
Strong organization skills, attention to detail, and the ability to work in a team environment.
ABOUT THE CLIENT
The client is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. They are trusted by healthcare professionals and patients across geographies. Over the last eight decades, they have strengthened their leadership in India’s pharmaceutical industry and fortified their promise of strengthening their global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Client employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees, who lead them to prosperity and growth in the future. Driven by the vision, none shall be denied, Client’s focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.