MSAT Sr. 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

Completes troubleshooting, process & compliance improvements, and potential introduction of new analytical technology. Continuous improvements include, but are not limited to, cleaning development, waste stream analysis, in process and release testing, and raw material specifications for commercial products. A key function of this role is to help reduce operating costs and defects while maintaining high throughput and overall compliance. This role will also directly support investigations into processes in commercial manufacturing and work on continuous improvements for the Production Department.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Ensure cGMP compliance, compliance to internal procedures, accuracy, and scientific soundness in support of commercial production
• Accountable for robust procedures and reports supporting commercial manufacturing as well as incoming commercial products (Phase III or undergoing validation). Supports analytical technology transfers as part of a team
• Supports commercial production and is accountable to drive higher throughput, lower costs, and improved robustness through continuous improvement of analytical methods and material specifications
• Develops, authors, or reviews analytical methods and specifications for commercial products (raw materials, intermediates, drug substances), including change controls
• Aids in support of vendor changes to raw materials, or specifications, or improvements. These areas both for legacy processes as well as new incoming processes
• Works with a team to implement technology transfers for new analytical technology, or techniques that are required for commercial processing, or will help drive improvements for the site
• Works on the establishment, implementation, and maintenance of a system of work standards within the framework of site procedures and regulatory guidance for MSAT activities
• Accountable to conduct root cause analysis for analytical related failures and identify correct preventative and corrective actions from their own investigation
• Collaborates with Quality Control and Development to help tech transfer methods and ensure knowledge sharing across groups to drive standard work across departments in regards to analytical methods
• Works with Operations Department, Deviation Team, Training Group, and Analytical Development to identify larger trends with analytical methods or analytical failures; and ensure appropriate CAPAs, and follow on projects, or update to current standards

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. Expected to work interactively and collaboratively across departments as well as with external project teams and clients.

Supervisory responsibilities include daily leadership of team; training and development; interviewing and hiring; managing time and attendance records; performance appraisals; rewarding and disciplining employees; and resolving daily problems and conflicts.

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 may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

A PhD or BSc in Chemistry/Analytical Chemistry or equivalent combination of education and work experience. Two years of practical work experience in API pharmaceutical processing, if holding a PhD or six years of practical work experience with a BSc; including all aspects of analytical chemistry support from scale-up and API Regulatory approval…