Drug Product Scientist
Workforce Genetics Gaithersburg, MD
- Expired: over a month ago. Applications are no longer accepted.
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.
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.
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