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 department-level leadership for the Synthetic Chemistry Department in accordance with the organization's policies and applicable regulatory requirements. The Manager’s 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 technical staff to improve skills, and ensuring high quality technical work.

The Process Chemistry department is responsible for the development of cost-effective, robust processes for the manufacture of products within the scope of the Corden business plan as well as continuous improvement, when needed, of the existing manufacturing processes.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Guides, directs, and reviews work done by the Synthetic Chemistry Department to ensure the robustness, scalability, and compliance with safety requirements of new and existing synthetic processes
• Ensures the proper technical resources and skills are in place, and appropriately applied to meet and exceed development and manufacturing goals
• Identifies technical, business, client-facing and interpersonal skill development needs of the members of the department and recommends appropriate training, either formal or on the job, and ensures training occurs
• Appraises the performance, rewards, and disciplines members of the department. Is responsible for hiring new members of the department
• Coordinates activities of synthetic chemical process research personnel responsible for developing innovative, efficient, safe, and economically advantageous processes for active drug substances and intemediates
• Develops and approves standard workflows to optimize the function of the department
• Ensures that improvements are constantly identified, prioritized, and implemented in the primary areas. Such as process development, as well as process improvements, technology transfers, and process robustness
• Establishes, implements, and maintains a system of work standards by developing guidelines and systems that ensure a consistently high level of technical work
• As a member of the Development Management, assists in setting goals, milestones, and completion dates; evaluates and determines resources (staffing, team makeup)
• Serves as Process Chemistry SME for internal and external customers. Ensures customer satisfaction and completion of deliverables on time and in full
• Utilizes metrics and work plan to track and continually improve process performance
• Identifies and provides development opportunities for team members
• Other duties may be assigned

Observes compliant working practices including completion of all required training, attendance at scheduled safety meetings, and performance of safe operating techniques in the labs, production areas, and office areas. Complies with all Quality, Environmental and Occupational Health and Safety policies and procedures, and governmental regulations

LEADERSHIP & BUDGET RESPONSIBILITIES

Provides leadership to the members of the department. Facilitates resolution of technical and interpersonal issues within the work group and between other work groups, providing performance feedback, work planning and addressing complaints and resolving problems.

Responsible for developing the budgets for the Synthetic Chemistry department and ensuring expenses are within the budgets.

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 of 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. 

EDUCATION and/or EXPERIENCE

Ph.D. in Chemistry or equivalent and a minimum of 7 years’ experience in pharmaceutical drug substance area development/production. 

LANGUAGE SKILLS

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.

MATHEMATICAL SKILLS

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

REASONING ABILITY

Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.,) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.

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.

• Ability to analyze manufacturing requirements and translate requirements to strategies that can be articulated and implemented in a manufacturing setting
• Understanding of the basic science and engineering associated with the manufacture of pharmaceuticals
• Project management skills: planning, staffing, organizing, directing and controlling
• Analytical problem-solving skills
• Working knowledge of regulatory issues in pharmaceutical manufacturing

• Communication – excellent oral and written skills
• Administration - able to organize group to achieve group goals and objective
• QbD – able to organize and execute development/transfer projects to support Quality by Design principles
• Regulatory Compliance – Excellent working knowledge of ICH guidelines/USP/EP/JP, SME for regulatory and quality inspections
• Quality Compliance – Performing and supporting investigations, determination of root cause, comprehensive knowledge of industry quality standards for method development, validation, and documentation
• Tech Transfers – Experienced in writing protocols, justifications, reports, etc.

SALARY

Actual pay will be based on your skills and experience.

BENEFITS

• 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service 
• Accident Plan
• Critical Illness Insurance
• Dental Insurance
• Disability Insurance
• Employee Assistance Program
• Flexible Spending Account
• Health Insurance PPO/HSA
• Hospital Indemnity Plan
• ID Theft Protection
• Life Insurance
• Paid Maternity/Paternity Leave
• Tuition Reimbursement
• Wellness Program
• Vacation – Three Weeks 1st Year
• Vision Insurance