Location: Buena, NJ
Essential Duties and Responsibilities:
- • Ensure the development and validation of analytical methods and improvement of existing ones to support all stages of drug development from drug substance characterization through formulations and process development and ANDA submission or oral and topical products.
• Actively lead formulation development through reverse engineering or innovator samples through testing and evaluation of R&D formulations.
• Manage analytical deliverables for ANDA projects – ensure that necessary supplies such as: standards, reagents, columns, impurities are available on time for projects.
• Prepare and review analytical data, technical reports and analytical methods in support of an for inclusion in the regulatory submissions.
• Compile, maintain, review and interpret analytical and statistical data. Assist with generating high quality technical documents required for method validation and ANDA submissions.
• Critically evaluation and interpret experimental data.
• Resolve complex problems.
• Ensure the maintenance follow all laboratory systems, GMPs.
• Prepare and review SOPs, as required.
• Keep supervisor informed of all key quality findings and issues.
• Provide guidance on resolution of complex issues to junior staff.
• Adhere to safety and housekeeping requirements.
• Other duties as assigned.
Education and/or Work Experience Requirements:
- • Minimum Bachelor’s degree in Organic Chemistry or related discipline with at least 7 years plus experience in the pharmaceutical industry or equivalent experience. MS/PhD preferred.
• Knowledge of cGMPs and CMC regulatory requirements and their utilization to support ANDA product registration.
• Strong foundation in the principles and applications of HPLC and detection systems, GC, UV/VIS. And other methodologies.
• Strong problem-solving skills.
• Collaborative working style. Demonstrated professionalism, cooperation and willingness to support team members and company priorities.
• Well-developer interpersonal skills.
• Good written and oral communication.
• Demonstrated ability to work on multiple projects and meet timelines.
- • While performing the duties of this job, the employee is regularly required to talk or hear.
• Employee is frequently required to stand for long periods of time; walk; use hands to handle or feel; and reach with hands and arms.
• Employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
• Employee is occasionally required to life weights up to 20-30 pounds.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
• The employee must be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.