The Analytical Development Chemist will perform studies for the development of immediate release and controlled release dosage formulations, topical formulations (creams and gels) and liquid formulations.

Responsibilities

  • Perform studies for the development of immediate release and controlled release solid-dosage formulations.
  • Perform testing on raw materials and in-process and finished dosage forms.
  • Write technical documents including laboratory notebooks, stability summary reports, methods and specifications for raw materials, in-process and finished products, method validation protocols and reports, planned deviation reports, incident reports, and change control forms.
  • Maintain technical documents in the analytical development department.
  • Calibrate and maintain analytical equipment: HPLC, GC, Dissolution Apparatus.
  • Interpret and analyze experimental data; identify the next steps to be taken and develop/optimize analytical test methods from research and development for the submission/clinical to production/commercial scale batches.
  • Direct the work of scientists and technicians in the analytical department, reviewing their laboratory notebooks, technical documents, analytical reports 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.
  • Communicate the status of various batches to the production, QA, RA and QC departments and to clients, as needed.

Competencies

The competencies for the AD Chemist role are divided into two pillars – Job Specific and Organizational competencies. 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

  • Analytical Thinking
  • Attention to Detail
  • Communication – Oral & Written

Organizational Competencies

  • Achievement Orientation
  • Adaptability
  • Initiative
  • Organizational Orientation
  • 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 as well as Formulation, QC and Production.

Thorough and accurate technical reports that are delivered on-time. Reports include:

  • Method Validation Reports
  • Stability Reports
  • Compression
  • 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.

Ability to think creatively in confronting new issues and pursuing novel approaches to old problems.

Physical Demands

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.

Job Type

Full-time

Required Education and Experience

Bachelor’s Degree in Chemistry required.

Proficiency in using computer, Microsoft Office Suite of products, ERP systems, etc.

3-5 years of chemistry related experience.

Experience in solid oral dose manufacturing and /or experience working in a GMP lab setting.

Other Duties

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 with or without notice.

If you’re interested in joining a diverse team where you can make a difference, please contact us at

careers@tedor.com

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