Associate Scientist I, Drug Product Development

Gaithersburg, MD

Posted: 03/06/2023 Industry: Scientific Job Number: 23-00099

Job Description

Support development of formulations for vaccines and characterization methods for the final drug product to ensure superior stability and manufacturing feasibility. Conduct pre-formulation and formulation development studies for liquid, frozen and lyophilized vaccines. Optimize formulations to ensure superior stability and manufacturing feasibility under GMP conditions. Hands-on support for various lab activities on daily basis.

Within CDMO, support execution of project work in the lab. Support various projects simultaneously in the operational execution. Support various tech leads to execute their development plans. Prepare documentation, experimental designs, perform sample preparation/manufacturing, analytical/characterization testing and data analysis. Prepare data summaries and presentations. I. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
  • Support scientists to develop appropriate assays to measure the content and purity of the biological and adjuvant molecules in the liquid and dry products.
  • Support scientists to develop physicochemical characterization assays and apply them at different stages of product development.
  • Perform data analysis using appropriate statistical methods.
  • Prepare technical reports, project monthly reports, PowerPoint presentations and other documentation reflecting the project(s) progress.
  • Help to identify formulations matrices that ensure the stability of targeted biological and the adjuvant molecules in liquid and lyophilized vaccines.
  • Plan, perform and execute short and long-term stability and compatibility studies and experiments to support CDMO projects, animal toxicity studies, CTM phase I/II/III studies and more.
  • Review and interpret data and present to immediate supervisor, team members on regular basis.
  • Write SOPs, protocol, monographs and technical reports.
  • Satisfactorily completes all development, cGMP/GLP and safety training in conformance with Departmental requirements.
  • Where applicable, performs job responsibilities in compliance with cGMP/GLP and all other regulatory agency requirements.
  • Performs other duties as assigned.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS Education: Bachelor's degree in physical sciences with some or no previous pharmaceutical industry experience or MS degree with no industry experience.

Experience: No necessary hands-on experience in developing formulations of vaccines and biologics but strong educational/scientific relevant background expected (especially preferred is strong biochemistry, chemical engineering, protein science knowledge).

Knowledge: Strong knowledge of scientific principles and concepts related to vaccine development. Chemistry, biochemistry, DoE and JMP analysis, (plus: regulations and guidelines in pharmaceutical industry (FDA, USP, EU, others)). Knowledge in GLP or cGMP is preferred.

Skills: Ability to work to tight deadlines and adapt to changing priorities in a fast-paced environment; ability and understanding in the selection of appropriate stability indicating techniques for evaluation of formulations; understanding and hands-on experience in running stability programs. Measurable learnings (e.G. Can perform at an Intermediate level of Excel and Word, Typing at 50 wpm, Advanced knowledge of research protocols, etc.).
  1. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.

The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


Physical/Mental Demands and Work Environment Characteristics :

Mental Demands: [THE 5 CHECKED ITEMS BELOW MUST BE CHECKED FOR ALL POSITIONS; ADDITIONAL ITEMS WILL APPLY FOR HIGHER LEVEL ROLES IN THE ORGANIZATION]
Ability to organize/coordinate Comprehend and follow instructions

Direct, control and plan Independently make quick decisions to solve complex issues

Problem Solve Analyze/Interpret data and information

Perform with frequent interruptions Make decisions using sound judgment

Supervise/Manage others

Physical Demands:
Good eye/hand coordination Visual Acuity

Use keyboard/computer/phone Detect/Distinguish smell

Detect/Distinguish hearing Maintain stationary position

Position self to move Move/Traverse

Ascend/Descend (climb) Reaching

Calibrate precise Ability to safely operate hand tools
measurements

Move/Transport [X] lb. Repetitive movement activities

Environmental Characteristics:

Regular and predictable attendance [MUST BE CHECKED OFF FOR ALL POSITIONS ]

Work around extreme temperatures cold or hot

Work around noise above conversation level

Work in restricted access to laboratory area

Exposure to dust/gas/fumes/steam/chemicals

Work with Select Agents as defined by the CDC

Work irregular hours that often include nights and weekends

Work in multiple locations

Travel:

No travel may be anticipated, but if it occurs it will be < 5-10%.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.

Meet Your Recruiter

Marion Bowden

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