Analytical Project Lead

Job Description

Job Description

EQUAL OPPORTUNITY EMPLOYER

Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.

CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with >

2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.

Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms : Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.

SUMMARY

Responsible for providing group-level leadership for the Analytical Chemistry Department in accordance with all regulatory requirements. Guides, directs, and reviews work done by Analytical Chemists to support the development of new methods and the performance of existing analytical developmental methods. The Group Leader also ensures the reliability, accuracy, and cGMP compliance in support of the validation of new and existing analytical methods. The Group Leader also supports and troubleshoots investigations into the performance of all analytical methods.

Further responsibilities include training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. The incumbent is responsible for creating an environment that encourages technical excellence, developing and coaching the group to improve skills, and ensuring high quality technical work.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Guides, directs, and reviews work done by their Group to ensure an exceptional level of project performance
• Responsible and accountable for all aspects of project performance within their group. Including meeting technical, timeline and budgetary objectives, as well as Client satisfaction
• Ensures experimental plans are designed to ensure project objectives are met
• Takes the lead in customers and interdepartmental communications or delegates to sufficiently trained and competent group members
• Enforces compliant working practices including completion of all required training, attendance at scheduled safety meetings, and performance of safe operating practices in the labs, production areas, and office areas
• Manages performance of group members according to Corden standards, job descriptions
• Is involved in professional development, recruiting, hiring, and promotions for the members of the group
• Applies principles of Continuous Improvement to ensure work processes and business process are meeting business and Client needs

LEADERSHIP & BUDGET RESPONSIBILITIES

Supervises and directs group directly in cooperation with department manager and project managers. Responsible for effective communication within the department, and externally to site and the company as appropriate.

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 in Analytical Chemistry or equivalent education and work experience. Five years of practical work experience in API pharmaceutical analytical development, including broad understanding of API Regulatory approval processes. Expert experience in the design and implementation of analytical techniques. Ability to formulate and articulate cohesive strategy for method development, including regulatory aspects. Advanced communication skills necessary to interrelate with external customers and other departments within the company structure.

LANGUAGE SKILLS

Ability to write reports, proposals, contracts, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.

MATHEMATICAL SKILLS

Ability to calculate figures and amounts such as proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. Ability to convert units of measurement.

REASONING ABILITY

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

CERTIFICATES, LICENSES, REGISTRATIONS

None.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to work with hands; reach above shoulder height; and taste or smell. The employee must occasionally lift and / or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles and low levels of toxic or caustic chemicals. The noise level in the work environment is usually moderate.

CORE COMPETENCIES

These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity. The candidate must be able to put into use the following core competencies :

SALARY

Actual pay will be based on your skills and experience.

BENEFITS

This Posting will Expire on January 17, 2025