Scientist I, Chemistry, Manufacturing & Control (CMC)

Cardinal Health • Lincoln, NE • 3d ago

What Chemistry, Manufacturing & Controls contributes to Cardinal Health

The Scientist I, Chemistry, Manufacturing, and Control (CMC) ensures efficient and quality production of product submission dossiers for Cardinal Health's Regulatory Science clients. Working remotely under the supervision of the CMC Supervisor, the Scientist I builds and formats Common Technical Documents (CTD) in preparation for submission in one or several countries across the globe. This job assists in preparing client reports and presentations and learns from experienced Scientists in order to develop its scientific writing and client-facing skills.

Location - Open to candidates nationwide, fully remote (work from home)

Responsibilities

Builds templates for CTDs in line with Board of Health and other requirements across countries in which dossiers are being submitted. Manages multiple work assignments in order to meet project timelines.

Drafts submissions for products, ensuring that all relevant product and client information and data is communicated in an effective manner. Seeks guidance from Supervisor and experienced Scientists on complex submissions and guides documents through internal systems for review.

Tracks the progress of dossiers in internal systems and in external submission systems and contributes to reports and presentations for clients. May serve as a project manager for smaller projects and ensure that team members achieve project milestones.

Supports experienced Scientists on complex tasks related to writing, formatting, and submitting dossiers in order to achieve project timelines. Under hands-on guidance of experienced Scientists, learns variety of internal, client, and regulatory systems and develop authoring and project management skills necessary for advancement.

Participates in client meetings in order to understand client needs and concerns, report on project progress, and develop client-facing skills by observing experienced Scientists.

Qualifications

Individuals with work experience in a GMP (Good Manufacturing Practices) or GLP (Good Laboratory Practices) environment, highly preferred though not required

Educational background in Chemistry or Biology, a plus though not required

Experience interacting (ex. submissions) with US FDA, a plus though not required

Meticulous attention to detail

Foundation in general scientific practice and in the principles and concepts of a discipline (e.g., chemistry, pharmaceutical science, pharmacy, biology, microbiology etc.) considered a plus

Sound knowledge of several aspects of regulatory principles, practices and concepts applicable to preparing regulatory submissions - a plus though not required

Rudimentary understanding of drug development or manufacturing/improvement processes, a plus

Understanding regulatory merits for scientific/technological development, a plus

Ability to switch between projects with competing priorities

Ability to adhere to internal and client timelines

Excellent communication skills (verbal and written); both to Management and peers

What is expected of you and others at this level

Applies basic concepts, principles and technical capabilities to perform routine tasks

Works on projects of limited scope and complexity

Follows established procedures to resolve readily identifiable technical problems

Works under direct supervision and receives detailed instructions

Develops competence by performing structured work assignments

LI-LP

LI-Remote

Anticipated hourly range: $30.70 per hour - $41.50 per hour

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with myFlexPay

Flexible spending accounts (FSAs)

Short- and long-term disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Application window anticipated to close: 05/16/2025 *if interested in opportunity, please submit application as soon as possible.

The hourly range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. 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.

To read and review this privacy notice click here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)

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