Principal Analytical Chemist

Corden Pharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical, and biotech companies manufacture medicines with the ultimate goal of improving people's lives.

Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms:
Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.

Our People Vision

We strive for excellence. We share our passion. Together, we make a difference in patients' lives.

SUMMARY

Performs and leads analytical research and development activities for the purpose of designing/improving a manufacturing process or technology as well as producing clinical trial batches by performing the following duties.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

* Leads large and/or multiple teams to accomplish technology transfers and/or development projects.

* Applies analytical and organic chemistry skills to the improvement of processes.

* Responsible for participating in the budget process of research projects and/or technology transfers.

* Initiates and executes the development of new and innovative analytical chemistry and methodology. Provides written analytical procedures and reports to support manufacturing and regulatory needs. Lead analytical technology transfer activities associated with a method or project.

* Develops a comprehensive understanding of internal, corporate, and ICH stability guidelines to provide support to the Corden Stability Program

* Develops and applies analytical techniques at a process scale (e.g., process chromatography)

* Responsible for the analytical sections of process procedures

* Develops key technologies and transfer strategies that function well in a manufacturing environment.

* Plans and formulates aspects of analytical research and development proposals such as objectives or purpose of project, applications that can be utilized from findings, cost of project, equipment, and human resource requirements.

* Identifies analysis points and develops methods, and procedures for monitoring projects. Devises and completes method validation studies.

* Practices excellence in verbal and written communication skills to update management and clients on the current statuses of each project. Maintains documentation such as analysis data and procedures and progress reports in accordance with GLP and company policies.

* Submits patents, presents at scientific conferences and company
-wide forums, and publishes in scientific journals.

* Investigates new analytical technologies and equipment with the aim of practical utilization in new and existing manufacturing processes.

* Develops expertise in key advanced analytical techniques.

* Analyzes batches of drug substance intermediates and raw materials to be used in clinical registration program.

* Proposes analytical specifications for control of raw materials, intermediates, in-process testing, and drug substances for in-house use and regulatory filings.

* Participates in manufacturing site activities, such as troubleshooting and analytical problem solving.

* Develops thorough understanding of QEH&S principles and regulatory affairs. Impacts analytical process development in at least two areas.

* Responsible for properly managing the generation and accumulation of hazardous and non-hazardous waste.

LEADERSHIP & BUDGET RESPONSIBILITIES

Demonstrates positive attitude. Supports a positive, healthy, and flexible work environment that encourages employees and coworkers to develop their full potential and expand their horizons. Leads team in the development, troubleshooting, transfer, and improvement of chemical processes. Expected to work interactively and collaboratively in a project team environment both internally and with clients.

Carries out leadership responsibilities in accordance with Corden policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraise performance, reward and discipline employees; address complaints and resolve problems.

SAFETY & ENVIRONMENTAL RESPONSIBILITIES

Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.

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. Reasonable accommodations…