732-661-0400

R&D Stability Supervisor

  • Location: DFW
  • Type: Direct Hire
  • Job #36027

Monitors day-to-day laboratory regulatory compliance, method and instrument performance, and leads or implements the development of analytical methods and investigations. Distributes and schedules work assignment in support of project activities.

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

Includes the following, but other duties may be assigned as company’s needs dictate.

  • Assures that reports of analyses, analytical methods, method  validation reports, method transfer reports and other technical reports are accurate, complete regulatory compliant, and conform to all relevant SOPs.

  • Formulation and drug stability studies: plan, prepare, manage, and report.

  • Distributes work assignments.

  • Participates in method development, validation, and transfer.

  • Ensures appropriate regulatory compliance in all relevant laboratory activities.

  • Participates in the various employee support systems such as reviews, interviews, and disciplinary actions.

  • Participates in or lead various elements of laboratory operations such as calibration, maintenance, housekeeping, and stocking of supplies.

  • Trains analysts in analytical methods and relevant procedures.

  • Assists the Manager in planning, staffing, budgeting, and other administrative tasks as required.

 

SUPERVISORY RESPONSIBILITIES: 

Supervises other Chemists/Analysts or Technicians. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities included interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

 

QUALIFICATIONS: 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE: 

  • Bachelor’s degree (B.A. or B.S.) in a scientific discipline; and 4 or more years related experience and/or training; or equivalent combination of education and experience. Must demonstrate knowledge of common analytical tools and techniques.
  • Experience in HPLC of active pharmaceutical ingredients (content and purity) and polymer characterization (thermal analysis (TGA and DSC) and gel permeation chromatography (GPC) preferred.
  • Experience in charactization of controlled release formulations including solubility, release kinetics, and stability.
  • Must have previous experience with conducting stability studies.
  • Must have previous management experience in a GMP environment.
  • Must have proven experience with various quality processes (e.g. investigations/deviations).

 

**This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you**

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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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