Manager, Analytical Research

Job Title:     Manager, Analytical Development

Location:     Columbus, OH

Job Type:    Full time

Req ID:        10705

 

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.  Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

 

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated Manager, Analytical Development to join our team.  

 

In this role, you will be responsible for leading an analytical group in support of the development of a manufacturable multi-source pharmaceutical product that is bioequivalent.  Ensuring that project timelines and quality/regulatory requirements are met.  Ensuring that rugged methods are developed and validated.  Monitor laboratory compliance to procedures/guidelines, cGMP.

 

Key Responsibilities:

• Leads an analytical group and ensures that, for the assigned projects, all the necessary analytical tasks for development, registration, filings and responses to deficiencies and other testing are correctly identified and executed within the project timelines. Ensures that results, potential issues/delays are timely communicated to the project team and management. Oversees group work assignment. Participates in definition of project strategies and timelines.

 

• Supports ANDA/IND/NDA regulatory submissions by developing suitable specifications, ensuring that rugged analytical methods are applied, ensuring that analytical information are shared within the project team and with internal customers. Defines and implements plans of action to respond to deficiencies. Responsible for the analytical documentation necessary for filing.

 

• Prepares and reviews relevant DPs, SOPs, guidances, protocols and reports to support laboratory GMP functions in compliance with FDA/regulatory guidances.

 

• Provides leadership, evaluates performance, oversees employee development, and mentors scientists within the group to minimize risk to the business and maximize value.

 

• Checks analytical data generated by the group. Ensures quality, accuracy and compliance status of the data generated.

 

• Communicates with direct reports, management, project teams, and internal and external customers about projects and business-related matters. Drives changes monitoring current systems, processes, procedures and working toward improving and refining them. Ensures that the group maintains compliance with cGMPs, cGLPs, FDA, ICH guidelines, SOPs, and DEA regulations. Ensures laboratory cleanliness.

 

• Participates in discussions on product strategies Interacts efficiently with Operation personnel (Quality, Launch, Stability) to ensure that technology transfer is performed. Ensures support to launch and commercial activities.

 

• The required work-related experiences include demonstrated knowledge of analytical development, validation, analytical instrumentation, chemistry along with the ability to troubleshoot analytical methods. Basic knowledge of organic/inorganic chemistry and basic understanding of toxicology is required.

 

• Demonstrated knowledge of the most current FDA/ICH guidances, Pharmacopoeias, ANDA/NDA/IND analytical requirements, and cGMP regulations is required to ensure compliance. Knowledge of DEA regulations is preferred.

 

• Project management skills are required.

 

• Must possess the ability to work on and manage multiple projects (multitasking) in a fast-moving and dynamic environment.

 

• Must possess demonstrated ability to communicate with all levels of management, to build and maintain inter a