Location: Buena, NJ
- 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 of sterile injectable and topical products.
- Actively lead formulation development through reverse engineering of innovator samples and 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 and 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 evaluate and interpret experimental data.
- Resolve complex problems.
- Ensure the maintenance and follow all laboratory systems, GMPS.
- Prepare and review SOPs, as required.
- Keep the supervisor informed of all key quality findings and issues.
- Provide guidance on the resolution of complex issues to junior staff.
- Train and mentor junior staff.
- Assume other activities and responsibilities as directed.
- Adhere to safety and housekeeping requirements.
- Minimum BS in Organic Chemistry or related discipline with at 7 + years of experience in the Pharmaceutical Industry or equivalent experience. MS/Ph.D. 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. Demonstrates professionalism, cooperation, and willingness to support team members and company priorities.
- Well-developed interpersonal skills.
- Good written and oral communications.
- Demonstrated ability to work on multiple projects and meet timelines.
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.
- 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; stoop, kneel, crouch, or crawl.
- Employee is occasionally required to lift 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 respirators, safety glasses, earplugs, and safety shoes.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.