POSITION: Scientist Formulation and Process Development
DUTIES:
- Responsible for Conducting Innovator Characterization, Pre-formulation/ Formulation development /Process development, Analytical Characterization for Complex Generic Drug Products and drug device combination products.
- Responsible for conducting research on Formulation /Process Development of various complex generic products, mainly Nasal Sprays, Tablets, Capsules and gels for US market. (which are supplied to US National contracts – Veteran Market).
- Responsible for Identification of Quality Target Product Profile (QTPP), Critical Process Parameters (CPP), Critical Quality Attributes (CQA), Critical material Attributes (CMAs) and Design space for the Formulations and Process variables.
- Responsible for writing & reviewing Formulation Design, Process Selection, Process Optimization and Packaging Components related Technical data sheets and GAP assessments.
- Responsible for drafting and reviewing Process related Risk Assessments (QRM)/FMEA and their mitigation plans.
- Responsible for drafting & reviewing Scale-up/Trial/Engineering Batch Protocols/Reports, Batch Manufacturing Records-BMR/Batch Packaging Records-BPR for Evaluation/Scale-up/Engineering/Submission/Process Performance Qualification Batches, Sampling Plans, Protocols/ Reports, Process Validation Protocols/Reports and Proposals for intended Commercial Batch manufacturing records.
- Supporting addressing agency deficiencies /queries received from various regulatory agencies and extends support to Regulatory team for product filing.
- Responsible for troubleshooting during commercial manufacturing.
- Responsible for development and maintenance of Device History File (DHF) documents for drug device combination products (Nasal Sprays).
- Responsible for conducting and monitoring the DHF related CMC studies and interpretation of results.
- Supporting Reformulation for Existing Products and New Product Launches
REQUIREMENTS: BS in Pharmacy, Pharmaceutical Science, Chemical Engineering, or other related fields and 60 months experience as a Process Development Scientist, Formulation Scientist, Formulation Chemist, or related occupation. OR MS in Pharmacy, Pharmaceutical Science, Chemical Engineering, or other related fields and 12 months experience as a Process Development Scientist, Formulation Scientist, Formulation Chemist, or related occupation. SPECIAL SKILLS: None Hours: 40 hours a week, 9:00 a.m. to 5:00 p.m. Salary: $110,000 to $125,000 range base salary/year + std company benefits Job site: 1 Ram Ridge Road, Chestnut Ave, NY 10977