Senior Development Engineer

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 strong technical leadership and documentation support for development processes. Responsible for the planning process fit, equipment sizing, scale-up engineering, and execution of multi-step syntheses from laboratory-to full validation-campaigns. Emphasis is on the creative application of a full range of practical and theoretical concepts toward the design and implementation of cost-effective processes for the manufacture of Corden pharmaceuticals.

Works within a team-oriented environment with professionals from a variety of disciplines. Conducts research, analysis, synthesis, experimentation, and documentation for such purposes as process development, implementation, registration, validation, and process improvement.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Ensures that processes developed are capable of meeting defined cost, yield, throughput, quality, and safety expectations on assigned processes
• Acts as a technical lead/SME within a project team to accomplish the development, transfer, or implementation of technology at a lab or plant scale
• Develops and supports scalable processes and provides technical expertise and support during lab or plant operations
• Responsible for supplying management with specific project data to facilitate the budgeting process for the development, transfer, or implementation of technology
• Develops and executes procedures, processes, and methods for solutions to engineering and technical problems on lab and plant scale
• Conducts research and development in order to improve development processes

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 and analytical processes. Gives regular reports to and actively solicits feedback from management.

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

Doctoral degree (PhD) in Chemical Engineering, plus 3 years of experience; or equivalent combination of education and experience, preferably specializing in Pharmaceutical Processes.

LANGUAGE SKILLS

Ability to read, analyze, and interpret common scientific and analytical 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 comprehend and apply principles of advanced calculus, modern algebra, and advanced statistical theory. Ability to work with concepts such as limits, and quadratic and exponential equations. The ability to select and perform engineering correlation calculations in support of scale-up (and scale-down) of processes. Familiarity with statistical design of experiments and process control.

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, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.

CERTIFICATES, LICENSES, REGISTRATIONS

Domestic and international travel may be required.

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; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

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 frequently exposed to fumes or airborne particles and low levels of toxic or caustic chemicals. The employee is occasionally exposed to moving mechanical parts, outside weather conditions, and risk of electrical shock. 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.

• Demonstrates a positive attitude
• Fundamental knowledge of chemical engineering principles. Good understanding of procedures and concepts within the field of engineering, chemistry, quality, and safety
• Perform lab experiments independently to achieve high quality data
• Experience in one or more of the following:

1. Process development, optimization, trouble shooting, and scale-up of chemical processes
2. Automated reactors with PAT tools, such as UV/Vis, turbidity, FBRM, PVM, EasyViewer, Raman, ReactIR, etc.
3. Crystallization and polymorphism
4. Calorimetry and thermal hazard analysis
5. Physical characterization using XRPD, TGA/DSC, microscope, etc.
6. Hands-on for chemical reactions, solvent distillations, filtration, and drying
7. Regulatory expectations including current Good Manufacturing Practices (cGMP), PSM, OSHA, and EPA requirements

• Maintain a well-documented record of work performed in a laboratory notebook; prepare laboratory reports, and campaign reports
• Regularly seeks out new learning opportunities beyond basic skills that can result in innovative approaches to technical issues
• Identifies areas where change/continuous improvement is beneficial to the business, and successfully defends and implements projects
• Proactive approach to problem identification and resolution
• Communicates effectively in writing and verbally within and across departments and to site management; updates are clear, selective, and effective
• Ability to provide expertise in common aspects of development processes; participates in the development, transfer, troubleshooting, and improvement of chemical processes in interactive, interdisciplinary team environment
• Seeks out opportunities to learn manufacturing needs and methods that facilitates substantial process improvements; acquires new skills in state-of-the art technology; and applies it to their assignments
• Demonstrates skills in negotiation and influencing others
• Creates clear, concise goals and strategies that support individual's development and the site's mission; actively participates in proposing and setting process chemist group and R&D Department goals
• Routinely demonstrates a proactive approach to problem identification and resolution
• Understands Corden's business goals and contributes technically to its strategy development
• Interacts with management in developing project objectives and site strategies; advises management regarding technical opportunities and advances

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