Scientist II, Chemistry, Manufacturing and Control

in Remote Location

Scientist II, Chemistry, Manufacturing and Control Job

Job Description Job Attributes+

  • Job ID

    3c52d57e-7e1e-4724-aaf4-bc39efe13d3a

  • Req #

    20118168

  • Job Location

    Remote Location

  • Job Category

    Research

  • Job Type

    Regular

  • Schedule

    Full time

What Chemistry, Manufacturing & Controls contributes to Cardinal Health

Research is responsible for the development of new and improved products through initiating, designing, developing and executing research and product development projects.

Consulting with clients and future clients on pre-approval and post-approval manufacturing of Rx and non-Rx products; ensures compliance with health authority regulatory requirements and may be called upon to perform compliance and gap closure audits; interacts with the Health Authorities on all aspects of manufacturing, testing and auditing of products; providing client recommendation of manufacturer/vendor to produce product. Can propose strategies as well as author relevant parts of dossiers for Health Authority registration. Contributes to global knowledge share of information including discussions/presentations industrywide.

Job Summary

The Scientist II, Chemistry, Manufacturing and Control delivers on projects that provide consultative advice to clients and future clients on pre-approval and post-approval manufacturing of Rx and non-Rx products. This job requires thorough understanding of regulatory drug substance and drug product development, and manufacturing requirements to manage project work and provide guidance to team members. The Scientist II, Chemistry, Manufacturing and Control provides research, document drafting and delivery support to consultative projects. This job is largely responsible for delivering on project objectives typically within an assigned area of expertise.

Responsibilities

Manages assembly of regulatory information for submissionAdheres to the client's defined submission preparation timelinesSearches document and change management databases for historical data/information that need to be captured in the updated regulatory submission.Using the client's templates for dossier sections, author CMC sections for routine submissions (e.g.,clinical trial amendments, Type I variations, IND/NDA/BLA annual reports, CMC renewals), includingadding technical data and descriptive textCollaborate with Data Verification Specialist to have submission content verifiedLiaise with Senior Submission Preparation resource to have work product reviewed

Location

Remote, telecommuter


Qualifications

MS/BS in Chemistry /Pharmaceutics with related science experience preferred2 years of related experienceFoundation in general scientific practice and in the principles and concepts of a discipline (e.g.,
chemistry, pharmaceutical science, pharmacy, biology, microbiology etc.)Sound knowledge of several aspects of regulatory principles, practices and concepts applicable to
preparing regulatory submissionsRudimentary understanding of drug development or manufacturing/improvement processesUnderstands regulatory merits for scientific/technological development or manufacturing activities


What is expected of you and others at this level

Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasksWorks on projects of moderate scope and complexityIdentifies possible solutions to a variety of technical problems and takes action to resolveApplies judgment within defined parametersReceives general guidance and may receive more detailed instruction on new projectsWork reviewed for sound reasoning and accuracy

Anticipated salary range: $75,000-$107,100

Bonus eligible: No

Benefits: Health insurance, 401k Contributions, Paid Time Off, Vacation, STD/LTD 

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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