Senior Scientist – Analytical R&D

Senior Scientist – Analytical R&D

Genus Lifesciences™ is a specialty pharmaceutical company engaged in the development and commercialization of generic and branded pharmaceutical products. Founded in 1999, Genus Lifesciences™ employs over one hundred fifty professionals in all phases of pharmaceutical operations, and its products are available in pharmacies and other retail outlets throughout the United States. In addition to its local presence, Genus Lifesciences™ has on-going research efforts through global partnerships related to its technology platforms.

Position: Senior Scientist – Analytical R&D

Status: Exempt, Salary

Reports to: Manager, Analytical R&D

Summary:

Using advanced analytical technologies, the Sr. Scientist will design, manage, and implement analytical development activities to support all stages of drug development. She/he represents the department in CMC teams and actively contributes to team strategies. Collaborates with cross-functional groups to meet drug development milestones. Demonstrates strong problem-solving skills. Develops, validates and transfers analytical methods for drug substance, drug product and excipients. Independently manages multiple projects and ensures timely delivery of all deliverables. Maintain high standard of documentation of work including GLP/GMP. Conduct relevant reverse engineering on competitive products. Assist in other activities within R&D Product as assigned by Supervisor. Act as a mentor to Scientist-1 and Lab Technician.

Responsibilities:

• Independently design and implement analytical development activities to support all stages of drug development.
• Represent department and actively participate in multiple CMC sub-teams: contribute to team strategies; provide high quality data to guide understanding and decisions; collaborate with other functional areas to solve technical problems and meet project development milestones.
• Must have knowledge and skills for Operation, Calibration, Qualification, Preventive maintenance and routine trouble shooting of analytical instruments like UPLC, HPLC, GC, UV spectrophotometer, Dissolution apparatus, KF Autotitrator, FT-IR Spectrophotometer, Polarimeter, Refractometer, Mass spectroscopy, Laser Diffraction Particle Size analyzer, etc.
• Develop, validate, and transfer analytical methods for drug substance, drug product and excipients.
• Troubleshoot and solve analytical problems to assure timely completion of projects and technical reports to meet CMC project timelines.
• Proactively identify potential analytical or project issues and mitigate or address appropriately.
• Prepare, review and approve analytical data, technical reports and analytical methods.
• Provide mentorship, training and guidance to associate level staff assigned on the projects and contribute to their development.
• Proactively develop and maintain state-of-the-art knowledge in current pharmaceutical and analytical sciences related to drug development.
• Make presentations at CMC meetings, departmental meetings, Pharmaceutical Development scientific meetings.
• Attend pertinent scientific conferences, workshops and technical training sessions to learn and bring in knowledge.

Education and Experience:

• Bachelor’s Degree (BA/BS) in chemistry or other relevant pharmaceutical sciences is required with minimum of 7 years of experience in analytical method development and validation.
• Master Degree (MS/MA) in chemistry or other relevant pharmaceutical sciences is required with minimum of 4 years of experience in analytical method development and validation.
• Extensive knowledge of Good Manufacturing Practices, FDA/ICH Guidelines, and Compendial references (USP/Ph. Eur., etc.).
• Experience using laboratory instrument data acquisition software (Empower, Chemstation, etc.).

Knowledge, Skills and Abilities:

• Proven verbal and written communications skills.
• Good subordinate and peer relationship skills.
• A strong demonstrated belief in continuous improvement.
• Good knowledge of cGMP, FDA and international regulatory requirements
• General personal computer skills – word processing, spreadsheet, graphics, and database.
• Proven concern with working in a safe and environmentally correct manner.

Physical Requirements:

• This position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance and lift up to 50 pounds.