Senior Scientist
2 weeks ago
Position Purpose or Objective
This position will be expected to perform advanced and critical analytical testing in addition to routine chemical analysis on in-process, finished products, stability, and raw material samples. The scientist is expected to work independently and must be able to develop high-quality, efficient, and stability-indicating HPLC, UPLC, and GC methods and execute method validation.
Major Areas of Responsibility
· Conduct analytical testing following approved test methods to test pharmaceutical products for conformance with established specifications. Perform analytical testing on R&D batches of various dosage forms, i.e., parentals, topicals, transdermal, solid oral, nasal products, and associated stability studies, and generate analytical reports.
· Propose product characterization requirements as per the USP and FDA guidelines
· Closely work with the FRD team to provide timely support
· Develop assay, related substances, and dissolution analytical methods in line with the formulation and write method development reports
· Prepare and review method validation, method verification and method transfer protocols.
· Conduct methods verification and method transfer of validated analytical procedures as required.
· Prepare and review specifications, test methods, and test results as needed.
· Maintain proper laboratory notebooks (follow GDP/GLP/cGMP) and prepare ARD/QC reports where applicable.
· Respond to all data reviews on a timely basis.
· Superior troubleshooting and problem abilities; troubleshoot technical problems for instruments, test methods and products.
· Support management in responding to audit findings on a timely basis.
· Complies with all relevant standard operating procedures (SOP’s).
· Follow all lab safety and housekeeping requirements.
· Perform other duties as assigned.
Required Knowledge, Skills and Abilities
· Advanced knowledge in the pharmaceutical industry with advanced instrumentation skills, including HPLC, UV-Vis, UPLC, ICP/MS and USP dissolution apparatus 1, 2, 3, 4, and 7.
· Demonstrated knowledge and understanding of LC/MS and GC/MS, XRD, TGA and DSC.
· Ability to enter data accurately.
· Ability to handle multiple tasks well.
· Ability to facilitate resolution of client issues.
· Must have advanced skills in Microsoft applications.
· Excellent interpersonal skills and ability to establish and maintain effective working relationships with both internal and external stakeholders.
Education and Experience
· BS in chemistry or related field with 10+ years’ experience
· MS in chemistry or related field with 8+ years’ experience
· PhD chemistry or related field with 5+ years’ experience
· Experience is expected to be in analytical labs, preferably in the pharmaceutical industry and working in injectable dosage forms is a plus.
· Recommendation by management
Planning Skills
· Ability to prioritize and plan the daily work to meet project timelines and manage multiple projects.
· Independent and Self-directed.
Accountability
· Responsible for ensuring that assigned projects and all lab activities are completed on schedule and within budget
Communication Skills
· Superior verbal and writing skills and interpersonal skills.
· Ability to work in a team environment and to facilitate teamwork
· Ability to facilitate communication with other groups.
Physical Demands
· This position requires the employee to routinely use a computer, Lab work (Chemicals)
Work Environment
· General office and Lab environment
Ingenus Pharmaceuticals LLC. is an Equal Employment Opportunity (EEO) employer and welcomes all qualified applicants. Applicants will receive fair and impartial consideration without regard to race, sex, color, religion, national origin, age, disability, veteran status, genetic data, or religion or other legally protected status.
Company DescriptionIngenus Pharmaceuticals wants to hear from you. Ingenus Pharmaceuticals is at the forefront of the rapidly growing generic medication industry, delivering access to safe, quality medications to U.S. consumers all across the healthcare continuum. Our company is built around the principles of innovation and ingenuity, a world-class leadership team, and—most importantly—the best and brightest people in the pharmaceutical industry. Are you ready for a new challenge? Do you enjoy working with a diverse group of patients, suppliers and partners? Then come to Ingenus, where you can truly make a difference; where together, we change the world, one medication at a time. We set high standards and reward them with competitive benefits. If you consider yourself a standout in your profession, let’s talk to find out if we are the right fit for you.Company DescriptionIngenus Pharmaceuticals wants to hear from you. Ingenus Pharmaceuticals is at the forefront of the rapidly growing generic medication industry, delivering access to safe, quality medications to U.S. consumers all across the healthcare continuum. Our company is built around the principles of innovation and ingenuity, a world-class leadership team, and—most importantly—the best and brightest people in the pharmaceutical industry. Are you ready for a new challenge? Do you enjoy working with a diverse group of patients, suppliers and partners? Then come to Ingenus, where you can truly make a difference; where together, we change the world, one medication at a time. We set high standards and reward them with competitive benefits. If you consider yourself a standout in your profession, let’s talk to find out if we are the right fit for you.
