What are the responsibilities and job description for the Chemical Process Engineer Group Leader position at Corden Pharma - A Full-Service CDMO?
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 US 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 technical and group-level leadership for process engineers on development and commercial products, as well as their own individual technical contributions. The position provides strong, technical leadership and documentation in the areas of process development, process improvement, troubleshooting, optimization, and manufacturing process support in assigned group or plant. Ensures the reliability, accuracy, and cGMP compliance of documents for production, validation, qualification, etc. and supports and troubleshoots investigations when required. Interacts with management in developing project objectives, department goals and site concepts & strategies; advises management regarding technical opportunities and advances.
Further responsibilities include training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. The group leader 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.
Provides leadership and oversight for process engineers in the group (see “Leadership Responsibilities” below)
Coaches, mentors, and trains less experienced engineers and other operations personnel on technical and business issues; encourages excellence by others to operate following Corden’s values and through positive feedback for good technical accomplishments and teamwork.
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.
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 BS in Chemical Engineering and 10 years’ experience of demonstrated success in Process Engineering in a Pharmaceutical or Fine Chemicals Manufacturing environment.
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 define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several 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 frequently required to stand, walk, sit, and talk or hear. 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 frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance 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 occasionally exposed to moving mechanical parts, fumes or airborne particles, low levels of toxic or caustic chemicals, outside weather conditions, and vibration. 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.
Actual pay will be based on your skills and experience.
Benefits
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 US 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 technical and group-level leadership for process engineers on development and commercial products, as well as their own individual technical contributions. The position provides strong, technical leadership and documentation in the areas of process development, process improvement, troubleshooting, optimization, and manufacturing process support in assigned group or plant. Ensures the reliability, accuracy, and cGMP compliance of documents for production, validation, qualification, etc. and supports and troubleshoots investigations when required. Interacts with management in developing project objectives, department goals and site concepts & strategies; advises management regarding technical opportunities and advances.
Further responsibilities include training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. The group leader 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.
Provides leadership and oversight for process engineers in the group (see “Leadership Responsibilities” below)
- Evaluates new process fits into manufacturing, considering safety factors, cost, equipment, chemistry, and unit operations for both new products and commercial products
- Performs process development via process modeling or testing at lab scale, concentrating on key scale up parameters. Develops and implements innovative process scale-up technologies that significantly improve our business’ ability to meet customer needs and business performance
- Identifies, evaluates, develops, and implements process improvements and optimization that reduces costs, improves yield/cycle time/quality, addresses EHS impacts, reduces downtime, and improves process consistency/robustness
- Supports Manufacturing by authoring process flow diagrams (PFD), providing technical information that serves as basis for batch records and drafting batch records, providing process training/training packages for operations and other support groups, authoring deviation investigations, and campaign summary reports, etc.
- Supports process validation by providing technical requirements for validation protocols and addressing validation deviations from a technical perspective
- Provides on-floor support to Manufacturing as needed: oversight of implementation of new processes or startup of commercial processes, troubleshooting of process and equipment issues, participating in change controls, etc. At times, this requires work outside of normal business hours
- Generates commercial scale fits and COGs estimates. Provides process technical input for capital projects that support commercial scale production needs. Participates in setting production standards for commercial processes
- Authors technical documents/reports in support of regulatory filings
- Serves as “Technical Team Lead” on broad, complex projects and responsible for directing the interdisciplinary technical teams’ efforts
- Provides updates (formal and informal) to Project Management and LT, as needed, regarding project progress, issues/issue resolution, and results
- Develops and implements innovative process scale-up technologies. Initiates and follows through on the development and implementation of new and innovative process chemistry, engineering and technology that significantly improve the environment, safety, and cost aspects of manufacturing
Coaches, mentors, and trains less experienced engineers and other operations personnel on technical and business issues; encourages excellence by others to operate following Corden’s values and through positive feedback for good technical accomplishments and teamwork.
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.
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 BS in Chemical Engineering and 10 years’ experience of demonstrated success in Process Engineering in a Pharmaceutical or Fine Chemicals Manufacturing environment.
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 define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several 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 frequently required to stand, walk, sit, and talk or hear. 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 frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance 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 occasionally exposed to moving mechanical parts, fumes or airborne particles, low levels of toxic or caustic chemicals, outside weather conditions, and vibration. 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.
- Broad technical expertise in chemical engineering and process improvement methodology
- Thorough knowledge of plant scale unit operations, scale-up, and plant design considerations
- Broad understanding of chemical reactivity, potential exotherms, cross-reactivity, side products, and waste streams
- Demonstrated ability to understand and apply statistical analysis and draw sound conclusions from the results; uses results when solving problems, or proposing improvements
- Thorough working knowledge and application of QEH&S Regulatory Compliance principles related to Chemical and Pharmaceutical Manufacturing including FDA, cGMPs, GDPs, EPA, OSHA, and PSM requirements
- Demonstrated leadership skills, including coaching, mentoring, and performance management
- Computer skills, in the areas of Microsoft Office Products – Word, Excel, PowerPoint; emissions modeling software; statistical analysis programs; and chemical engineering simulation software
- Stays current with processing-related equipment, technology, and innovations through regular reading of trade journals, contact with suppliers, and affiliation with professional organizations
- Seeks 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
- Establishes and maintains external technical contacts
- Sought for high profile projects, advice/consulting, or problem solving; recognized for high levels of creativity and technical expertise
- Routinely demonstrates a proactive approach to problem identification and resolution
- Understands Corden’s business goals and contributes technically to its strategy development
- Demonstrated ability to interact with management in developing project objectives and site strategies; advise management regarding technical opportunities and advances
- Demonstrated communication skills (presentation, persuasion, written, oral) across all levels of the organization. Prepares clear and well-organized reports on extensive, independent work. Produces entirely self-generated presentations for audiences including upper management, and outside of the site.
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
Salary : $110,127 - $123,950
