15 days old
2017-11-072017-12-07

Technical Services Scientist II

Lannett Company Inc.
Seymour, Indiana 47274
  • Job Type
    Employee
  • Job Status
    Full Time
  • Shift
    1st Shift

A Technical Services Scientist applies a thorough understanding and a wide application of technical principles, theories, and concepts to support the new development and commercial launch of solid-dose products. The scientist will also apply technical knowledge, creativity, and company practices to obtain solutions to complex problems while meeting project time lines. This position is viewed as a technical resource in process development, process/equipment troubleshooting, process optimization/scale-up, and technology transfer. The scientist will identify and evaluate critical process parameters, conduct statistical analyses, and utilize experimental design techniques. The scientist will work in partnership with Research & Development and Commercial Support at various product stages.

 

Essential Functions:

  • Design and conduct studies (qualification of new equipment and new materials, process development/improvement/scale-up, and technology transfer) in compliance with established SOPs, FDA/ICH guidelines, DEA regulations and safety requirements.

  • Provides analysis, evaluation and initial interpretation of varied data including technical assessments of products and manufacturing processes.

  • Provide timely effective resolution to manufacturing problems of a technical nature.

  • Provide technical assistance to Validation in identifying critical process parameters

  • Assist the Manufacturing, Validation, Compliance and Regulatory Affairs groups with technical input.

  • Author technical documents (reports, protocols, MBRs, procedures, etc.)

  • Write eCTD development sections and provide written justifications and answers to complete response letters and information requests from agencies.

  • Ensures appropriate records are maintained in a complete and orderly manner.

  • Collaborate with other functional groups within the site to achieve project goals and meet the timelines. Prepares and presents varied data at internal meetings.

  • Performs scientific literature searches and evaluations as required.

  • Effectively leads technicians and technical associates in conducting batch manufacturing and in-process sampling/testing.

  • Provide work leadership and directions to less experienced staff members.

Requirements

  • Bachelor’s degree or advanced degree in Science, Engineering, or Pharmaceutics.

  • Minimum of 5 years pharmaceutical manufacturing experience. Experience in solid-dosage formulation/process development, manufacturing support, scale-up, and technology transfer is highly preferred.

  • Possesses project management skills; strong verbal and written communication skills.

  • Possesses applied knowledge of root cause analysis and troubleshooting techniques. Able to apply statistical analyses and experimental design techniques. Technical competence and writing skills.

  • Strong customer/quality focus. Knowledge of pharmaceutical GMPs and regulatory (FDA, DEA, OSHA) requirements. Adherence to all health, safety, and environmental requirements. Work in safe and efficient manner.

  • Proficient with MS Office

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Technical Services Scientist II

Lannett Company Inc.
Seymour, Indiana 47274

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Technical Services Scientist II

Lannett Company Inc.
Seymour, Indiana

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