CMC Manager

US Tech Solutions; Morristown (TN); On-site; USD 80,000 - 100,000; Full time

Job summary

A global staff augmentation firm is seeking a CMC Manager to support the Morristown team. You will be responsible for drafting technical registration documents and ensuring compliance with industry standards. The ideal candidate possesses a degree in the sciences and has experience in authoring submissions as well as managing change controls. Strong technical report comprehension and post-approval product maintenance experience are essential. Join us to contribute to the growth and success of our clients.

Qualifications

• Degree in the sciences required.
• Experience in authoring submissions and change controls is essential.
• Strong understanding of technical reports and post-approval maintenance needed.

Responsibilities

• Draft or update technical registration dossiers for pharmaceutical products.
• Evaluate change requests and define technical requirements according to guidelines.
• Coordinate preparation of draft responses to technical-regulatory questions.

Skills

Ability to understand technical reports

Experience in authoring submissions

Understand change controls

Experience in post-approval maintenance

Education

Degree in the sciences (chemistry, biology, etc.)

Job description

US Tech Solutions is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit our website www.ustechsolutions.com.

We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, sets the correct expectation and thus becomes an accelerator in the mutual growth of the individual and the organization as well.

Keeping the same intent in mind, we would like you to consider the job opening with US Tech Solutions that fits your expertise and skillset.

Job Description

Title: CMC Manager

Location: 36 Columbia Rd., Morristown, NJ, USA, 07962

Duration: 12+ Months

Job Description:

This position will support the Morristown CMCD team.

The CMCD team is responsible for providing technical leadership to ensure compliance in the development of Chemistry, Manufacturing and Control (Module 3) technical documentation for commercial products.

The job purpose is to prepare technical CMC registration documents in order to maintain the existing marketing authorization (i.e. dossier updates, variations, renewals, response to deficiency letters, compliance gap closures) in various countries where is doing business.

The primary job duties and responsibilities include the following.

• Draft or update the technical registration dossiers (CTD Module III and QOS or equivalent) of pharmaceutical products
• Evaluate change requests with a goal of defining technical requirements according to guidelines
• Work with manufacturing sites and contract sites to ensure the on-time compilation of high quality CTD Module III documents
• Evaluate and manage the Technical CMC dossier documentation involved in change requests (including manufacturing site transfers) of pharmaceutical products
• Discuss and align with customers on the regulatory strategy for maintenance activities
• Maintain knowledge of current industry requirements and standards for CTD Module III and post-approval activities
• Represent CMCD team in cross functional project, process and/or infrastructure teams as required.
• Coordinate the preparation of draft responses to technical-regulatory questions from health authorities including writing of expert statements and scientific justifications.

Requirements:

• Degree in the sciences (chemistry, biology, etc.)
• Ability to understand technical reports (stability, validation, manufacturing)
• Experience in authoring submissions (variations, supplements, annual reports)
• Understand change controls and dossier maintenance
• Experience in post-approval maintenance of products