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Chemist II, Analytical Documentation
Job Description
Target PR Range: 25-35/hr
*Depending on experience
Overview:
Join our Parenteral Product Development Science and Technology - Analytical Development group and contribute to exciting programs transitioning from the development stage to optimization and commercialization. As a member of the team, you will support the development, optimization, and validation of analytical methods by ensuring that they are well documented. You'll gain experience in documentation of product control strategies, analytical methods, and stability studies. This is not a laboratory position.
Key Responsibilities:
· Support Analytical Leads and Lab Managers by assisting with the creation and review of protocols, reports, specifications, and other technical documents. This may include facilitating communication between different laboratories, reviewing data, drafting sections and data tables, data verification, and other tasks as needed.
· Execute change management processes for document updates.
· Assist in compiling and verifying information for submissions and responding to health authority queries.
· Gain hands-on experience in regulatory compliance and analytical data.
Qualifications:
· Bachelor’s Degree in a scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology) and 5+ years’ experience or Master’s Degree with 2+ years’ experience.
· Basic understanding of analytical methods, test method validation, and Good Documentation Practices.
· Good organizational skills and attention to detail.
· Ability to manage and prioritize multiple projects simultaneously and to work within timelines.
· Interest in learning and developing scientific writing skills.
· Interest in learning about international pharmaceutical guidelines and regulatory submission processes.
Preferred Qualifications:
· Practical experience in method validation of analytical or bioanalytical techniques (for example: HPLC, SEC, CEX, icIEF, CE-SDS, ELISA, etc.) is a plus.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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