ALL APPLICANTS MUST SUBMIT RESUMES IN MICROSOFT WORD OR ADOBE PDF FORMAT.
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.
The Associate Scientist position is an individual contributor role and reports to the Research & Development (R&D) Manager for InvaGen/Cipla 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.
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.
OTHER JOB INFORMATION
Employment sponsorship negotiable.
No remote work available.
Based on business needs, must be willing to work some weekends as required.
Additional Salary Information: Variable Pay Performance Bonus of 10%
Internal Number: ASSOCSCIANCHEM06042020
About InvaGen Pharmaceuticals, a Cipla subsidiary
InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited. The company is also referred to as Cipla New York.
The Cipla New York site consists of three manufacturing facilities and a diverse workforce performing a variety of roles such as senior scientist, quality control chemist, quality assurance associate, regulatory affairs analyst, manufacturing and production operators, and other business and technical positions.