Position Purpose or Objective
The Sr. Chemist or Chemist – QC is responsible for testing of raw materials, packaging materials, in-process samples, finished products and stability samples. Candidate must have experience with the instruments like HPLC, GC, Dissolution, IR, Disintegration, AAS etc. Experience with the Empower software 3 is must.
Major Areas of Responsibility
· Testing in process, raw materials, packaging materials, finish products and stability samples for commercial products
· Analysis of developmental samples and stability samples in support of ANDA Submissions
· Conduct method validations/verifications/Method transfers all under GMP protocol
· Participate in feasibility and experimental method development to optimize the analytical methods
· Create certificate of analysis for all the type of materials and products
· Experience in participate in Lab deviations, investigation and Audits if necessary
· Prepare test methods, specifications, protocols and reports
· Knowledge and understanding of cGMPs, Good Laboratory Practices and Good Documentation Practices.
· Demonstrate professionalism to coworkers, customers and an understanding of quality in a regulatory industry
- Technical expert and experience with the instruments HPLC, GC, AAS, Dissolution, IR, DT, UV etc is must.
- Must be able to able to work independently, organized, effectively prioritize projects and work in team environment
- Experience with the control substances testing and handling
- Proficient with Microsoft word and Excel
- Experience with laboratory note book documentation is preferred.
Required Knowledge, Skills and Abilities
· Excellent interpersonal skills and ability to establish and maintain effective working relationships with both internal and external stakeholders
· Excellent verbal and written communication skills
- Ability to work with minimal supervision
- Experience establishing and maintaining relationships with key decision makers
- Strong analytical skills and ability to understand business and financial implications of contracts
Education and Experience
· Minimum BA or BS required
- Minimum 3-7 years in analytical development or Quality control of Pharmaceutical Generic Products preferred
· This position requires the employee to routinely use a computer and telephone.
- Ability and willingness to work additional hours as required by business needs
· General office environment and Lab
Ingenus Pharmaceuticals, LLC, is a privately-owned U.S. based pharmaceutical company. Our vision is to be recognized as the most innovative, collaborative and responsive company in the generic pharmaceutical industry.
Ingenus believes lower-cost generic medication improves patient access and offsets overall healthcare costs. Since 2010, Ingenus has helped to make a difference by developing, manufacturing and commercializing quality generic medications as cost effective solutions for patients, suppliers and stakeholders all across the healthcare continuum.