Job Summary

Develop and optimize analytical methods for pharmaceutical products using HPLC, UPLC, Ion Chromatography, UV-Vis, Dissolution Baths, Empower-3; Perform analytical Method Validation, Method Development and Method Transfer; Perform sample analysis for Assay, impurities and dissolution; Perform analytical work in compliance with cGMP and SOPs; Calibrate and maintain Analytical Instruments including pH meter, Dissolution Bath, HPLC, UPLC, DSC, Viscometer, Density meter, Osmometer

Qualifications and Skills

• 2 years experience in job offered. Require skills and knowledge in Empower 3, Method Development/Method Transfer, HPLC, UV-Vis, cGMP, Dissolution.

Education

• Must have a Master Degree in Pharmaceutical Science or Chemistry

Job Location

• Somerset, NJ.

How to Apply

Send resume with job code BAY001 to HR, Odin Pharmaceuticals, 300 Franklin Square Dr, Somerset, NJ 08873.

Job Summary

The Sterile Operations Manager is the most responsible person for the development of procedures and practices necessary for the manufacturing of sterile pharmaceutical products. This person will aid in the design, layout, qualification, and start-up of a new manufacturing facility for injectable and ophthalmic products. This position will be responsible for hiring, management, and performance of both salaried and hourly direct reports.

Responsibilities and Duties

• Responsible for the development, training, implementation, and approval of all sterile production documentation, procedures, and manufacturing records
• Overseeing the development, qualification, validation, and documentation of manufacturing systems, equipment, and processes for aseptically manufactured products
• Demonstrating effective writing skills for drafting SOP’s, batch records, protocols, and reports
• Overseeing validation activities, including IQ/OQ/PQ’s on new manufacturing equipment and providing support and guidance to Engineering and Quality Assurance departments.
• Responsible for supporting the scale-up and optimization of current and new manufacturing processes within the company. Recommends improvements and efficiencies.
• Evaluating and optimizing manufacturing processes and keeping manufacturing areas inspection ready at all times
• Manages production staff including scheduling of manufacturing activities [formulation, filling, and finishing] lines.
• Demonstrating and applying a thorough understanding of engineering and scientific principles related to pharmaceutical manufacturing.
• Maintaining up to date knowledge with respect to relevant state-of-the-art technology, equipment, and/or systems
• Ensure GMP compliance with applicable US laws, rules, and regulations and maintaining knowledge of cGMP compliance
• Establishes and conforms to departmental budgets
• Acts as the manufacturing liaison with regulatory agencies (FDA, DPH, EPA, and OSHA during site inspections
• Representing the company in a professional manner in all interactions with other employees, customers, and suppliers.

Qualifications and Skills

• Minimum 10 years’ experience in sterile injectable pharmaceutical manufacturing including sterile formulation, fill, and finishing operations.
• Previous experience in a supervisory position.

Education

• Bachelor’s degree in a scientific field

Job Type

• Full-time

Job Summary

Perform chemical and physical testing for complex inhalation product formulations under general supervision. Conduct testing in a cGMP laboratory and document those experiments per cGMP requirements. Calculate, organize, and communicate results using standard data templates and reports. Provide general laboratory assistance including planning, designing, and executing experiments. Edit SOPs, protocols, methods, and reports.

Responsibilities and Duties

• Perform analytical testing for inhalation products according to the established testing method, per cGMP requirements.
• Analyze samples, process data, and document in a laboratory notebook.
• Organize and maintain the functionality of the lab.
• Edit SOPs, protocols, methods, and reports.
• Self-motivated with moderate supervision in a detail-oriented manner
• Can work independently as well as in a group environment.
• Plan, design, and execute experiments with guidance from supervisor/senior staff.

Qualifications and Skills

• Possess good organizational skills, a commitment to quality work, and good oral and written communication skills.
• Work effectively as part of a team.
• Experienced with HPLC, GC, KF, FTIR, or other analytical instrumentation preferred.
• Experienced in testing inhalation dosage forms preferred.
• Bachelor’s degree in Chemistry, Chemical Engineering, or related preferred.
• Self-motivated with moderate supervision in a detail-oriented manner.

Education

Job Type

• Full-time