The role of the Analytical Development Chemist includes performing tasks such as:
- Develop HPLC/GC methods for analysis of finished dosage forms (small molecule)
- Perform studies for the development of immediate release and controlled release dosage formulations (solid oral dosage forms).
- Perform testing on raw materials and in-process and finished dosage forms.
- Write technical documents including laboratory notebooks, project summaries, validation reports and protocols, planned deviation reports, incident reports, and change control forms.
- Maintain technical documents in the analytical development department.
- Calibrate lab equipment, interpret and analyze experimental data, identify the next steps to be taken and perform scale-up and technology transfers of formulations from research and development to the submission/clinical to production/commercial scale batches.
- Collaborate with scientists and technicians in the analytical development department, reviewing their laboratory notebooks, project summaries, and standard operating procedures.
- Attend project meetings.
- Manage R&D projects and report project progress to the project manager.
- Communicate the status of various batches to the production, QA, RA and QC departments and to clients, as needed.
- Assist in FDA filings.
- Review project contracts.
- Assist IT in development and implementation of the database system.
- Assist Manager in providing strategic inputs for the project advancement
- Involved in critical thinking & testing to determine the appropriate solutions for the challenges in a project
- Managing multiple projects simultaneously
- Assist with internal & External communication, improving transparency & distributing timely information about the project
The job specific competencies identify the technical skills one must possess in the AD Chemist role to be successful. The organizational competencies identify the broad skills and behaviors everyone at Tedor must possess and apply to drive organizational results.
Job Specific Competencies
Attention to Detail
Communication – Oral & Written
Teamwork and Cooperation
AD Chemist Core Performance Outcomes
- Analytical development methods and method validation protocols that are designed to meet the project purpose and objectives
- Projects and testing executed according to all compliance standards and with accuracy
- An accurate interpretation of data to validate methods and provide guidance and support to team members in Formulation, QC and Production\
- Thorough and accurate technical reports that are delivered on-time. Reports include:
- Method Validation Reports
- Stability Reports
- Certification Analysis
- Issues that are dealt with appropriately according to GMP standards and with sense of urgency
- Instruments maintained and in good working order
- Proactive identification and ownership of a problem and required solution
- Trusting and collaborative working relationship with team members and with other departments
Level 1: Office Environment and Production Environment
This job operates in a professional office environment as well as the Production and Warehouse environment. This role routinely uses standard office equipment such as computers, phone, photocopiers, filing cabinets and fax machines, as well as commanding the understanding and sometimes operation of complex machinery used in the manufacturing of solid oral dose drug products.
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. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required
to stand; walk; use hands to finger, handle or feel; and reach with hands or arms. Must be able to lift 10 pounds.
Position Type and Expected Hours of Work
This is a full-time position requiring a minimum of 40 hours of work per week Monday through Friday. Some responsibilities may require work outside of normal office hours.
Required Education and Experience
Bachelor's Degree in Chemistry required. Proficiency in computer usage and Microsoft Office required.
- 3-5 years of chemistry related experience.
- Experience in cGMP laboratory setting.
- Proficiency in using computer, Microsoft Office Suite of products, ERP systems, etc
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time without notice.
Job Type: Full-time
- chemistry: 4 years (Required)