Tedor is a privately held Pharmaceutical company that develops generic drug products via the ANDA process for itself and partnerships as well as works on taking IND applications requiring drug product development and cGMP manufacturing through the NDA process. Tedor offers a comprehensive benefit package including medical, dental and vision insurance, a 401(k) plan with company matching and paid time off.
Tedor is recruiting for an experienced Senior Formulator or Associate Formulator to join a growing Drug Development and R&D department. This position will support the drug development activities to generate a generic ANDA submission through commercialization and/ or a NDA in a broad technical/ science based, multi-functional, hands-on capacity.
This position requires and understanding of the pharmaceutical product development process including pre-formulation, formulation, scale-up, technical transfer and ANDA submission activities. Each formulator will have expertise in pharmaceutical processes including granulation, blending, fluid bed coating/ drying, milling, drying, compression or encapsulation and pan coating for tablets or capsules, while monitoring stability study results. Important to this position is the characterization of materials and processes as part of a Quality by Design approach to the drug development process in support of ANDA filings.
The Formulator will perform all aspects of each drug design studies, perform in-process testing (rheological properties), analyze and interpret data of varying complexity, and makes recommendations. These recommendations will be generated via written technical documents, reports, protocols and responses to regulatory inquire. It is expected that a formulator be able to apply scientific fundamentals to solve complex formulation, stability and manufacturing issues while developing strong working relationships with internal colleagues and external contract organizations.
Independently design and perform formulation experiments leading to the development of a stable bioequivalent generic product. Evaluate the stability of selected formulations at various storage conditions. Perform technology transfer for manufacturing processes from laboratory scale to the production scale. Coordinate with other departments for execution of exhibit/submission batches per regulatory requirements. Provide technical support for process validation studies. Write master formulas, manufacturing procedures, SOPs, Product Development Reports etc. Responsible for all formulation/ process related CMC documents which will be part of regulatory filings. Perform weekly inspection of satellite hazardous waste accumulation area.
Perform semi-complex adjustments to laboratory and production equipment/instruments, calibration and preventative maintenance of equipment and appropriate documentation. Maintain a safe, clean and organized working environment by performing routine R&D area/lab housekeeping and reporting any unsafe conditions.
Qualifications:
A Senior Formulator will demonstrate strong leadership ability and excellent oral and written communication skills with formalized training via a:
PhD in Pharmaceutical Science, Chemical Engineering, or related science typically with a minimum of 5 years of pharmaceutical or related work experience in the field or
MS in Pharmaceutical Science, Chemical Engineering, or related science typically with a minimum 8 years of pharmaceutical or related work experience in the field or
BS in Pharmaceutical Science, Chemical Engineering, or related science typically with a minimum 12 years of pharmaceutical or related work experience in the field.
An Associate Formulator will demonstrates a working knowledge of pharmaceutics principles and excellent oral and written communication skills with formalized training via a:
BS in Pharmacy, Chemistry, Food Science, Chemical Engineering or other related field with 3-5 years of pharmaceutical formulations and a minimum of one (1) year experience in the formulation of tablets and/ or capsules.
Must be familiar with Microsoft Office (i.e., Excel, PowerPoint, Word, Mini-Tab)
EOE
Job Type: Full-time
Work Location: In person