Avet Pharma Labs is seeking to hire an R&D Scientist II. This position will be located at 21B Cotters Lane, East Brunswick, NJ.
- This position has no direct reports.
- Maintains project tracking tools to inform Senior Management of the status, progression, critical success factors and risk factors in the ongoing and planned drug development projects, including reports and trackers.
- Generate and execute all process characterization/validation protocols of all site transfer project to HPL in an FDA regulated environment.
- Utilize knowledge of Code of Federal Regulation (CFR) 210 & 211
- Coordinates and facilitates communication and removes roadblocks between cross-functional team members and outside business partners.
- Oversee batch manufacturing at third party CMO sites including hands on involvement for exhibit batches.
- Transfer of technology for new products from R&D or other sites to manufacturing site.
- Plan and manage successive phases of developmental and transfer activities including production of research, Scale-Up, Exhibit/ Registration for ANDA submission, component changes and process validation batches.
- Developing strategy to optimize manufacturing process for existing products (Tablets, capsules and softgels).
- To provide technical guidance to oversee scale-up help with trouble shooting formulation, manufacturing and analytical issues.
- Oversee process validation and cleaning validation reports at conclusion of validation studies.
- Conduct program management to ensure activity alignment to ensure timely partner product launches.
- Writes and manages department SOP’s, training etc. to ensure regulatory compliance and operations enhancement, Responsible for site transfer and technology transfer of new product.
Specialized Skills and Knowledge:
- Master’s Pharmaceutical Sciences, Chemistry, Chemical Engineering or related and 2 years of exp in job or as Validation Engineer.
This position is primarily sedentary in nature. The employee may be required to lift up to 25 lbs.
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.
Avet is proud to be an Equal Opportunity Employer.
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.