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Cmc Manager Jobs in Ohio (NOW HIRING)

WuXi Biologics Group

$100 - $130/hr

... with EU BD, CMC, and BU teams. Your Responsibilities: * Partner with EU BD to Drive Qualified ... Serve as EU lead management owner in SFDC for marketing-sourced and marketing-influenced leads.

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Cmc Manager information

See Ohio salary details

$21.9K

$58.3K

$97.4K

How much do cmc manager jobs pay per year?

As of Aug 30, 2026, the average yearly pay for cmc manager in Ohio is $58,326.00, according to ZipRecruiter salary data. Most workers in this role earn between $41,800.00 and $65,600.00 per year, depending on experience, location, and employer.

What is a CMC manager?

CMC Managers, or Chemistry, Manufacturing, and Controls Managers, are professionals responsible for overseeing the development, production, and quality control processes of pharmaceutical products. They ensure that all aspects of drug manufacturing comply with regulatory standards and that the product is safe, effective, and consistent. CMC Managers coordinate between research, development, regulatory affairs, and production teams to streamline processes and solve technical issues. Their work is crucial for securing regulatory approval and bringing medicines to market efficiently.

What are some common challenges a CMC manager faces when coordinating cross-functional teams during drug development?

A CMC Manager often navigates complex challenges such as aligning timelines and priorities between research, manufacturing, quality assurance, and regulatory teams. Ensuring effective communication and data transfer across departments is crucial, especially when dealing with global teams or external partners. Additionally, adapting to evolving regulatory requirements and managing resource constraints while maintaining project momentum are frequent hurdles. Success in this role relies on strong project management, problem-solving skills, and the ability to build collaborative relationships across diverse functional areas.

What are the key skills and qualifications needed to thrive as a CMC manager, and why are they important?

To thrive as a CMC Manager, you need expertise in chemistry, manufacturing, and controls (CMC) regulations, drug development processes, and a relevant scientific degree, often with experience in the pharmaceutical or biotechnology industry. Familiarity with regulatory submission systems, quality management software, and documentation tools such as eCTD is typically required. Strong project management, leadership, and cross-functional communication skills help coordinate teams and manage complex timelines. These competencies are vital for ensuring regulatory compliance, efficient product development, and successful market approval.

What is the difference between Cmc Manager vs Cmc Specialist?

AspectCmc ManagerCmc Specialist
CredentialsBachelor's or Master's in Life Sciences, Chemistry, or related field; often requires industry certificationsSimilar educational background; certifications may enhance prospects
Work EnvironmentOversees teams, manages projects, liaises with regulatory agenciesExecutes specific tasks within projects, supports Cmc managers
ResponsibilitiesStrategic planning, team leadership, regulatory submissionsData compilation, documentation, technical support

The Cmc Manager typically holds a leadership role, overseeing Cmc specialists and managing regulatory processes, while the Cmc Specialist focuses on technical execution and documentation. Both roles require similar educational backgrounds and industry experience, but differ mainly in scope and responsibility.

What are the most commonly searched types of Cmc jobs in Ohio?

The most popular types of Cmc jobs in Ohio are:

Cmc Manager jobs near you
Infographic showing various Cmc Manager job openings in Ohio as of August 2026, with employment types broken down into 90% Full Time, 9% Part Time, and 1% Contract. Highlights an 81% Physical, 2% Hybrid, and 17% Remote job distribution, with an average salary of $58,326 per year, or $28 per hour.

R&D Product Development Director

New Albany, OH • On-site

American Regent, Inc.
Pharmaceutical and Medicine Manufacturing • 501 - 1,000 employees

7.2

Company rating: 7.2 out of 10

Based on 12 frontline employees who took The Breakroom Quiz

72nd of 86 rated pharmaceutical

Great coworkers

Good employer

Paid breaks

Learn more about American Regent, Inc.external

Full-time

Re-posted 25 days ago

Job description

Nature and Scope
The R&D Product Development Director is a pivotal leadership role responsible for the end-to-end strategy and execution of pharmaceutical drug product development, with a primary focus on innovative injectable dosage forms. This role oversees programs from ideation through commercial launch, ensuring scientific rigor, regulatory compliance, and alignment with enterprise growth objectives.
This position requires deep scientific expertise across complex formulations, CMC strategy, analytical and bioanalytical testing, combined with strong business acumen and cross-functional leadership. The Director serves as a key strategic partner in advancing the company's portfolio, collaborating closely with Portfolio Management, Clinical, Regulatory Affairs, Manufacturing, and Commercial teams to optimize execution, accelerate development timelines, and pioneer differentiated drug delivery solutions.
Essential Duties and Responsibilities
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
  • Lead the development and execution of comprehensive pharmaceutical development strategies, ensuring all R&D programs meet global regulatory standards and corporate objectives.
  • Oversee the preparation, review, and approval of critical pharmaceutical development documentation, including Technical Transfer Documents, Product Development Reports (PDRs), CMC sections, and regulatory submission materials supporting clinical, registration, and commercial batches.
  • Apply Quality by Design (QbD) principles and risk-based methodologies to accelerate development timelines while maintaining scientific excellence and compliance.
  • Serve as the scientific authority in Portfolio Management Committee meetings, providing technical leadership and strategic input for NDAs, 505(b)(2) applications, ANDAs, and NADAs.
  • Maintain expert-level knowledge of parenteral drug delivery technologies and relevant patent landscapes; proactively contribute to intellectual property strategy and differentiation initiatives.
  • Develop and execute long-term R&D strategies aligned with corporate growth objectives and emerging industry trends in injectable and complex dosage forms.
  • Identify and advance 505(b)(2) opportunities to create differentiated, value-added formulations for both new and existing products.
  • Partner with Development, Medical, Commercial, Regulatory, and Manufacturing teams to build a commercially viable and strategically differentiated product pipeline.
  • Contribute to the Scientific Affairs leadership team by shaping and executing the mission, vision, and operational priorities of the R&D organization.
  • Recruit, mentor, and lead a high-performing technical organization focused on complex generics, First-to-File (FTF), and First-to-Launch (FTL) parenteral products.
  • Establish and champion robust talent development and succession planning processes, fostering a culture of accountability, innovation, and continuous professional growth.
  • Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
  • Ph.D. in Life Sciences (Chemistry or Pharmaceutical Science concentration) required.
  • Minimum of 10 years' in formulation, analytical, and process development with a proven track record with complex molecules, including solutions, lyophilized products, suspensions, and novel drug delivery platforms.
  • 7+ years of demonstrated leadership experience managing a team.
  • Deep understanding of the drug discovery lifecycle and global regulatory requirements. Experience in a start-up biotech environment and familiarity with advanced drug development platforms would be a plus.
  • Exceptional technical writing and interpersonal skills; ability to influence at the executive level.
  • Excellent oral and written communication skills.
  • Ability to prioritize and perform multiple tasks simultaneously.
  • Ability to make decisions independently and with appropriate input.
  • Ability to work well in a matrix environment, particularly with QA/QC, Manufacturing Operations, Project Management and Regulatory Affairs.
  • Flexibility in adapting to multiple therapeutic areas and/or projects interchangeably.
  • Strong computer skills (Word, Excel, PowerPoint, and Outlook).

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
Applicants have rights under Federal Employment Laws.
  • FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
  • Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
  • Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

Alert: We're aware of individuals impersonating our staff to target job seekers. Please note:
• All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.
• Our recruiting process includes multiple in person and/or video interviews and assessments.
• If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding.
• We never request payment, bank information, or personal financial details during our offer process.
Your security is important to us, and we encourage you to stay vigilant when job searching.
American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.

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