Scientist I, Chemistry, Manufacturing, and Control (CMC)

Lensa; Lansing (MI); Remote; USD 60,000 - 80,000; Full time

Job summary

A leading company seeks a Scientist I for Chemistry, Manufacturing, and Control (CMC) to assist in the production of regulatory submission dossiers. This fully remote role involves drafting submissions, managing project timelines, and developing skills with experienced scientists while ensuring effective communication and adherence to internal standards.

Benefits

Medical, dental, and vision coverage

Paid time off plan

401k savings plan

FSA and HSA accounts

Flexible working arrangements

Qualifications

• Work experience in a GMP or GLP environment is preferred.
• Experience interacting with US FDA is a plus.
• Rudimentary understanding of drug development or manufacturing processes is advantageous.

Responsibilities

• Builds templates for Common Technical Documents (CTDs).
• Tracks the progress of dossiers and contributes to client presentations.
• Supports experienced Scientists on complex tasks related to submission.

Skills

Attention to detail

Problem solving

Communication skills

Education

Educational background in Chemistry or Biology

Job description

Scientist I, Chemistry, Manufacturing, and Control (CMC)

Scientist I, Chemistry, Manufacturing, and Control (CMC)

2 days ago Be among the first 25 applicants

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Lensa is a career site that helps job seekers find great jobs in the US. We are not a staffing firm or agency. Lensa does not hire directly for these jobs, but promotes jobs on LinkedIn on behalf of its direct clients, recruitment ad agencies, and marketing partners. Lensa partners with DirectEmployers to promote this job for Cardinal Health.

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, ability to be reliable, and willingness to problem solve (basic computer skills) - required
• 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
  
  

Anticipated hourly range: $31.50 per hour - $44.80 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: 07/15/2025 *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)

If you have questions about this posting, please contact [e-mail]

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  IT Services and IT Consulting

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