Location: Buena, NJ
Providing high quality product development, analytical method development and validation in a GMP environment. Support new product development for topical and injectable products through analysis of innovator samples and R&D formulations.
- 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 oral and topical products.
- Formulation research, development, experimental design, optimization and scale-up for topical and parenteral products.
- Manage Analytical deliverables for ANDA projects – ensure that necessary supplies such as: standards, reagents, columns, impurities are available on time for projects.
- Conducts/guides physio-chemical characterization and pre-formulation studies to investigate chemical compatibility, degradation pathways, physical attributes, and the targeted product profile.
- Generate and compile documents for ANDA submissions and response to deficiency letters from FDA.
- Critically evaluate and interpret experimental data for conclusions and resolution.
- Resolve complex problems. Provide suggestions and problem resolution based on technical expertise.
- Supervise analytical testing in support of formulation development of topical and oral dosage forms. Prepare and review analytical data, technical reports and analytical methods in support of and for inclusion in the regulatory submissions.
- Facilitates ordering of drug substances, excipients, packaging components with the Purchasing Department and assures lead times and availability and communicates to Team Leaders the impact on timelines.
- Prepares, executes, and reports lab and commercial scale formulation for stability and process evaluation to assure robust product development.
- Compile, maintain, review and interpret analytical and statistical data. Assist with generating high quality technical documents required for method validation and ANDA submissions.
- Conduct investigations and write investigation reports, as appropriate.
- Adhere to safety and housekeeping requirements.
- Keep management informed of all key quality findings and issues.
- Provide guidance /training on resolution of complex issues to junior staff.
- Assume other activities and responsibilities as directed.
- Prepare pre-commercial Batch Records via collaboration and execution with the Technical Transfer and the Manufacturing Team to optimize commercial scale manufacturing batches.
- This position requires minimum 5 years industrial experience with a proven track record for developing successful parenteral and topical products. Bachelor’s in science plus 7-10 years related industrial experience or master’s with 5-7 related industrial experience.
- 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.
- Abilities to think and act independently and interact with other departments.
- Well-developed interpersonal skills.
- Good written and oral communications.
- Demonstrated ability to work on multiple projects and meet timelines.
- While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
- 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.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs