Senior Scientist, Denville, NJ

Job responsibilities: 

Design and formulation development of sterile liquid injectable formulations for oncology APIs, addressing challenges related to solubility, stability, and potency through advanced formulation strategies, including the use of co-solvents, surfactants, and pH modifiers. Conduct pre-formulation studies, excipient and container-closure compatibility assessments, and risk evaluations. Conduct pre-formulation studies, excipient and container-closure compatibility assessments, and risk evaluations. Support process development, optimization, and tech transfer; oversee scale-up activities, aseptic filtration, terminal sterilization, and fill-finish operations.

Design and formulation development of oral solid dosage forms, including immediate release and extended-release tablets and capsules for the US regulatory market by applying Quality-by-Design (QbD) principles and risk-based approaches to optimize formulations and processes. Conduct literature search and pre-formulation studies. Supporting the technology transfer of formulation and process from the development site to the manufacturing site. Preparing chemistry-manufacturing control (CMC) documents (PDR/QOS, etc.) for regulatory submissions/ANDA filings. Preparing drug substance and product/In-process/finished product/stability specifications and their justifications as per US FDA/ICH guidelines.

Conduct formulation feasibility and process optimization studies, prepare pilot batch documentation, ensure availability of raw materials, and complete batch documentation as required. Coordinating with other related departments like Quality Control, Quality Assurance, Engineering and Regulatory Affairs. Coordinate handling of Controlled Substances. Performing reverse engineering in the development of pharma products. Maintaining formulation development lab notebook/equipment documentation work. Development of Patent non-infringement bioequivalent dosage forms and coordinate review/analysis of Patents. Preparing elemental impurities and Nitrosamine impurities assessment reports. Applying chemical engineering principles in developing new products.

Qualifications and Experience:

• Applicant must have a Master’s degree (or US Equivalent) in Pharmaceutics, Chemistry, Pharmacy or related field.
• Two (2) years’ experience in generic formulation research, including immediate-release, extended-release and delayed-release tablets and capsules (multi-particulate systems).
• Hands-on experience in preparing drug substances and drug products, in process, finished product, and stability specifications and justifications according to US FDA/ICH guidelines.
• Experience in preparing & reviewing regulatory CMC documents such as PDR, QOS, BMR and responses to CRLs/IRs for regulatory submissions.
• Review/analysis of patents and development of patent non-infringement dosage forms.
• Designing and executing experiments, employing quality by design (QbD) principles. Preparation of Process Evaluation Protocols, Batch Production Records, and Validation/Exhibit batch summary.
• Preparation and evaluation of Nitrosamine impurities and Elemental impurities in Drug substances/drug products.
• Experience in the technology transfer of formulation and process from the development site to the manufacturing site.
• Hands-on experience handling equipment such as a high-shear granulator, Tablet press, Tablet coating machine, Bilayer compression machine, Roller compactor, hot melt extruder, and fluid bed processor.
• Experience in reviewing documents in compliance with SOPs, FDA Regulations, and cGMP policy.

40 hours per week. M-F: 9:00 a.m. to 5:00 p.m. Must have proof of legal authority to work in the United States.

Salary: $80,974 – $85,000 per year.

To be considered, please visit RiconPharma LLC’s, an Ingenus Pharmaceuticals affiliate, career site website at https://www.ingenus.com/careers/ and apply by emailing your resume to hr@ingenus.com.

Job Number: 22026