Kaztronix
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Associate Stability Research Scientist II
LosAngeles, CA US
Posted: 05/21/2023
2023-05-21
2023-06-27
Industry: Scientific
Job Number: 23-00236
Job Description
Summary:
The incumbent will work in a supporting function to provide scientific and technical assistance in the research and development of plasma derived or recombinant proteins or in support of the manufacture of plasma derived or recombinant proteins. The incumbent successfully performs in their position supporting a compliant stability program for licensed products and developmental projects, ensuring the on-going quality and safety of marketed material, in addition to implementing solutions to a variety of company related objectives.
Primary responsibilities for role:
Executes action plans in support of departmental objectives independently or as part of a team.
Provides technical reports to immediate supervisor and within group meetings.
With supervision, writes procedures or technical reports.
Communicates technical data to immediate supervisor and capable of communicating technical results in team settings.
With minimal supervision, develops solutions to technical problems within area of expertise.
Applies professional principles, established techniques, and company's policies and procedures in completion of job tasks.
Assists in study design.
Executes experiments with supervision.
The incumbent provides support to the Stability Group by overseeing all facets of the Stability program that are related to the chamber area including storage, delivery
and documentation of the sample inventory.
Analyzes chamber temperature and humidity trends on a daily basis to evaluate any issues. Primary contact for calibration and validation of stability equipment.
Plans the scheduling of weekly activities, performs weekly audits of Stability areas for both GMP and Safety items.
Archives Stability documentation in PRM, perform Visual Inspection and VIT testing. Issues logbooks.
Generates service requests and investigations to resolve any issues. Communicates updates to the team.
Communicates chamber and equipment related updates to the team.
Provide support for products (marketed and/or development)
Provide stability support for the research and development of plasma derived proteins
Knowledge in the use of SAP program
Position requires organizational and experimental design skills
Knowledge of the Regulatory guidelines, licensed product lines, routine test methods, and developmental projects related to stability studies
Demonstrated ability in technical report writing and attention to detail
Knowledge in usage of an electronic based Document Control Management (DCM) system
Communicates effectively and promptly supporting department objectives and management decision
Additional Responsibilities:
Maintains work areas in accordance with company policies and industrial best practices.
Provides support for research and developmental studies, clinical or commercial manufacturing as needed.
Primary contact for adressing chamber alarms (24/7). Responsible for the inplementation of a plan of action and notification of management. Organizes the movement of
Stability samples while maintaining the product quality
Knowledge, Skills, and Abilities:
Must have organizational skills and ability to prioritize personal tasks to meet deadlines.
Must have strong written and oral communication skills.
Demonstrates knowledge in area of specialization.
An understanding of International Conference of Harmonization (ICH) guidelines and requirements set forth by regulatory agencies associated with the storage of Stability
product is required.
Proficient with the use of MS Office software.
Must have effective written and oral communication skills
Education:
Educational degrees must be relevant to position (e.G., Biology, Biochemistry, Chemistry, or Toxicology
Experience:
MS Degree
BS + 1-2 yrs
No degree + 5 yrs
Equivalency:
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an
Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience.
The incumbent will work in a supporting function to provide scientific and technical assistance in the research and development of plasma derived or recombinant proteins or in support of the manufacture of plasma derived or recombinant proteins. The incumbent successfully performs in their position supporting a compliant stability program for licensed products and developmental projects, ensuring the on-going quality and safety of marketed material, in addition to implementing solutions to a variety of company related objectives.
Primary responsibilities for role:
Executes action plans in support of departmental objectives independently or as part of a team.
Provides technical reports to immediate supervisor and within group meetings.
With supervision, writes procedures or technical reports.
Communicates technical data to immediate supervisor and capable of communicating technical results in team settings.
With minimal supervision, develops solutions to technical problems within area of expertise.
Applies professional principles, established techniques, and company's policies and procedures in completion of job tasks.
Assists in study design.
Executes experiments with supervision.
The incumbent provides support to the Stability Group by overseeing all facets of the Stability program that are related to the chamber area including storage, delivery
and documentation of the sample inventory.
Analyzes chamber temperature and humidity trends on a daily basis to evaluate any issues. Primary contact for calibration and validation of stability equipment.
Plans the scheduling of weekly activities, performs weekly audits of Stability areas for both GMP and Safety items.
Archives Stability documentation in PRM, perform Visual Inspection and VIT testing. Issues logbooks.
Generates service requests and investigations to resolve any issues. Communicates updates to the team.
Communicates chamber and equipment related updates to the team.
Provide support for products (marketed and/or development)
Provide stability support for the research and development of plasma derived proteins
Knowledge in the use of SAP program
Position requires organizational and experimental design skills
Knowledge of the Regulatory guidelines, licensed product lines, routine test methods, and developmental projects related to stability studies
Demonstrated ability in technical report writing and attention to detail
Knowledge in usage of an electronic based Document Control Management (DCM) system
Communicates effectively and promptly supporting department objectives and management decision
Additional Responsibilities:
Maintains work areas in accordance with company policies and industrial best practices.
Provides support for research and developmental studies, clinical or commercial manufacturing as needed.
Primary contact for adressing chamber alarms (24/7). Responsible for the inplementation of a plan of action and notification of management. Organizes the movement of
Stability samples while maintaining the product quality
Knowledge, Skills, and Abilities:
Must have organizational skills and ability to prioritize personal tasks to meet deadlines.
Must have strong written and oral communication skills.
Demonstrates knowledge in area of specialization.
An understanding of International Conference of Harmonization (ICH) guidelines and requirements set forth by regulatory agencies associated with the storage of Stability
product is required.
Proficient with the use of MS Office software.
Must have effective written and oral communication skills
Education:
Educational degrees must be relevant to position (e.G., Biology, Biochemistry, Chemistry, or Toxicology
Experience:
MS Degree
BS + 1-2 yrs
No degree + 5 yrs
Equivalency:
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an
Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience.