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.

The Supervisor, Chemistry, Manufacturing and Control provides 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 Supervisor, Chemistry, Manufacturing and Control provides project management oversight to all assigned projects to ensure on time and cost effective delivery of projects that meet and exceed client demands. This job is largely responsible for delivering on project objectives typically within an assigned area of expertise. In addition to delivery, this job frequently provides feedback to more junior team members.

• Consulting with clients and future clients on 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 industry wide.
• Possesses a thorough knowledge of regulatory drug substance and drug product development, and manufacturing requirements. Can develop and execute sound strategies for manufacturing and registration of Rx and non-Rx products. Willing to contribute to discussions/presentations industry wide. Strong client focus with an enterprising/corporate mindset. Communicates with a sense of urgency, timely and clearly with the client and worldwide health authorities.·
• Provide guidance and assistance to clients in a timely manner regarding research challenges, issues, concerns, questions, and strategies associated with the drug development and manufacturing processes. Communicates with a sense of urgency, timely and clearly with the client and worldwide health authorities. Uses experience to develop strategies to streamline strategic planning, execution, control, and close-out processes (including but not limited to formulation development, manufacturing, validation, compliance, authoring, auditing, gap closures).·
• Collaborates well with internal and external stakeholders in achieving project goals. Has a strong foundation of Pharmaceutical knowledge. Interacts with subject matter experts and regulatory authorities, as required, including preparation for and attendance at meetings and teleconferences to advance research objectives. Demonstrates expert knowledge and understanding of relevant scientific design/strategies, operations, products, and services including interactions, communications and management thid party sites, vendors, and related resources.·
• Uses experience to develop strategies to streamline development and approval process. Has a fundamental background of Pharmaceutical knowledge. Interacts with subject matter experts to gain knowledge and experience. Preparation and verification of regulated documentation. Demonstrates knowledge and understanding of relevant scientific design/strategy, operations, products, and services.·
• Demonstrates strong teamwork with internal resources, SMEs to capitalize on intellectual property. Interacts with subject matter experts to gain knowledge and experience. Data mining and verification of regulated documentation.·
• Proactively identifies potential issues, analyzes options and provide recommendations to the client. Understand and support the nature of our business and our company’s commitment to quality and responsiveness. Work with business development to prepare customer-specific proposals. Manage budgets with primary focus on clinical research deliverables. Is a strong leader not only of current team but also influencing the culture of the company.·
• Encourages informed risk-taking and acts as a catalyst for innovation; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources. Completes projects on time and within budget. Strong leadership in both project and people management. Impacts the culture of the company.·
• Encourages informed risk-taking and creative options to solve problems. Creates business opportunities, while maximizing existing resources. Completes projects on time and within budget. Leadership in both project and people management. ·
• Encourages informed and creative options to solve problems. Creates business opportunities, while maximizing existing resources. Completes projects on time and within budget. Leadership in both project and people management.

Responsibilities

• Coordinates and supervises the daily activities of operations, or business support staff
• Administers and executes policies and procedures
• Ensures employees operate within guidelines
• Decisions have a direct impact on work unit operations and customers
• Frequently interacts with subordinates, customers and peer groups at various management levels
• Interactions normally involve information exchange and basic problem resolution

Location

• Remote, telecommuter

Qualifications

• 4-8 years of CMC experience, preferred
• Bachelor's degree in related field, or equivalent work experience, preferred
• Possesses a thorough knowledge of regulatory drug substance and drug product development, and manufacturing requirements
• Project Management experience preferred
• Pharmaceutical background is a plus

Anticipated salary range: $88,500-$126,400

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.