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Drug Product Scientist

Workforce Genetics Gaithersburg, MD

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

We are seeking a Drug Product Scientist responsible for understanding Parenteral aseptic processing as it relates to drug product manufacturing. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards. Influence and implement the technical agenda within a multi-discipline technical environment. Work with peer leadership in a positive fashion to deliver on functional technical objectives, deviation reduction, specific product business plan, and quality objectives.

Responsibilities include but are not limited to:

  • Act as primary technical resource for vaccine drug product manufacturing.

  • Author regulatory submission documents.

  • Provide input into user requirement documents.

  • Assist with the selection of equipment that meets the present and future process needs.

  • Act as primary technical resource for isolator technology, formulation/compounding, filling processes and inspection.

  • Identify process issues and plan and implement process improvements.

  • Author and provide input into technical standard operating procedures.

  • Assess impact and document process deviations.

  • Assess process performance by monitoring and analyzing process/product.

  • Author and perform design of experiments activities to ensure the equipment and processes meet the requirements.

  • Write/prepare manufacturing instructions.

  • Prepare protocols and conduct process validation.

  • Provide technical coaching and floor support to manufacturing.

  • The development and implementation of process/technology improvements, and the day to day scientific support for the manufacturing operations.

  • Assess impact and document process deviations, troubleshoot processing issues.

  • Define critical parameters and evaluate process improvements

  • Assist in product site transfers as required.

Minimum requirements:

  • BS / MS pharmacy, chemistry, engineering or related fields.

  • 5-7 years' experience in pharmaceutical parenteral manufacturing (aseptic processing).

  • Exposure to aseptic manufacturing technique. Working understanding of sterile drug product development.

  • Basic understanding of commercial manufacturing equipment and knowledge of GMPs.

  • Excellent verbal & written communication skills.

  • Understanding of tech transfer process for aseptic manufacturing procedures.

  • Assessment Test(s) if applicable.

  • Knowledge of technical support (i.e. development, scale-up, validation, quality control, registration, etc.) for vaccine parenteral manufacturing operations is preferred.

  • Excellent verbal & written communications skills and proficiency in Word/Excel/Powerpoint is required.

Workforce Genetics

Address

Gaithersburg, MD
USA

Industry

Science

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