Process Chemistry Group Leader

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 Process Chemistry department to provide results in order to meet business needs. Guides, directs, and reviews work done by process chemists to support the development of new pharmaceutical processes. The Group Leader ensures the technical feasibility, economic competitiveness, and overall robustness of new and existing processes. The Group Leader also supports and troubleshoots investigations into processes in non-commercial manufacturing.

The Group Leader’s further responsibilities include training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and 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, while 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 Process Chemistry Group to ensure the level of performance for new and existing pharmaceutical 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, and interpersonal skill development needs of the members of the group and recommends appropriate training; either formal, or on the job, and ensures training occurs
• Appraises the performance, rewards, and disciplines members of the group. Is responsible for recruiting, hiring, and in making salary recommendations for the members of the group
• Plans and formulates aspects of Process Chemistry such as objectives or purposes of a project, applications that can be utilized from findings, and resources required to meet timelines
• 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, procedures, and guidelines as well as government regulations
• 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.
• Analyzes emerging technology for potential implementation
• Establishes, implements, and maintains a system of work standards by developing guidelines and systems that ensure a consistently high level of technical work

LEADERSHIP & BUDGET RESPONSIBILITIES

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

SAFETY & ENVIRONMENTAL RESPONSIBILITIES

Every individual is personally responsible for the safety and environmental aspects of their 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

Five years of practical work experience in API pharmaceutical process development, including all aspects of Process Chemistry from scale-up and process safety considerations to the API Regulatory approval process. Exhibits expert abilities in the design of chemical processes, and in the implementation of common unit operations. The ability to formulate and articulate a cohesive strategy for process development, including its regulatory aspects. Advanced communication skills are necessary to interrelate with external customers and other departments within the company structure.

EDUCATION and/or EXPERIENCE

PhD in Chemistry or equivalent combination of education and work experience.

LANGUAGE SKILLS

The 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 general 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

The 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, diagrammatic, 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; 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.

• Communication – oral and written
• Administration - able to organize group to achieve group goals and objectives
• Analytical Methodologies – HPLC/UPLC, GC, IR, UV, IC, NMR
• Analytical Instrumentation – comfortable with the use of common analytical techniques
• Process Instrumentation – understanding common development tools such as pressure vessels, large-scale lab equipment (20-50 L), optical analysis probes, parallel process development equipment, and the like
• Regulatory Compliance – excellent working knowledge of ICH guidelines/USP/EP/JP, SME for inspections
• Quality Compliance – performing and supporting investigations, determinations of root cause and preventative measures

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