Associate Scientist - Analytical Chemistry

Job Description

Required Citizenship/ Work Permit/ Visa Status:

• US Citizens / Green Card Holders / Visa Sponsorship negotiable

• Must be from Pharma Company


• 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 mu


• 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.

Relocation Negotiable

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 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. 


• 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.

 OTHER JOB INFORMATION

• Relocation negotiable.


• Employment sponsorship negotiable.


• No remote work available.


• Based on business needs, must be willing to work some weekends as required.

INDEGENE PVT LTD

Indegene is a specialized healthcare solutions company with a unique blend of life science domain expertise and state-of-the-art technology capabilities. Headquartered in Bangalore, with offices across the world, Indegene is partner to most of the world’s Top 25 pharma companies helping transform their commercial and medical operations.

As life sciences companies embrace digital and omni-channel marketing for more personalized customer engagement, Indegene helps enable this shift by integrating commercial content development with deep data, analytics and campaign expertise. Across brands and geographies, we help some of the world’s largest pharma companies drive consolidation and excellence in omni-channel customer experiences by integrating data operations, and advanced analytics into the design and personalization of customer campaigns and creation of digital content. This is enabled by bringing together deep analytics expertise and contemporary AI and Big Data technology to establish Global Centres of Excellence for Marketing Operations.

Further upstream in the pharma product lifecycle, we are helping companies to integrate multiple sources of clinical, safety and real world (electronic medical records, claims, wearables, etc.) data and perform nuanced, domain-specific analytics on them. By doing so, we are helping pharma and life sciences companies accelerate their clinical trials, detect safety signals and garner real world evidence to engage with external provider, patient and payor communities.  

Indegene also has a proven track record of partnering with clinical, regulatory, safety and medical teams of life sciences companies (pharmaceutical, biotech and medical devices) to drive productivity, compliance, speed and global scale in content development. By customizing bleeding edge AI/NLP and Structured Content Authoring tools to automate the analysis and creation of medical content, we are helping companies reduce time to regulatory submission, streamline the development of medical communications and increase the throughput of their medical review processes.

Indegene is at the forefront of innovation to transform regulatory, medical and commercial operations and drive thought leadership in the journey from generation and analysis of data to creation of content to personalization of stakeholder experiences.

To capitalize on this unique positioning and to deliver measurable business impact, we are looking for a Business Development Leader  to expand our footprint across clients with strategic and suitable solutions for better business outcomes. The role will work directly with our global clients to understand requirements, and aid in defining world class solutions that will wow our clients and users and ensure success. The position works closely with business leadership different verticals, marketing, operations, technology, finance, and other functions globally.