What are the responsibilities and job description for the Process Implementation Specialist 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 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
The Process Implementation Specialist acts as the single point of contact for implementation of one or more chemical manufacturing processes within the Corden Pharma Boulder and Corden Pharma Colorado (CPB and CPC) manufacturing areas to ensure schedule adherence and right the first time. In this role, the Process Implementation Specialist is responsible for the coordination, execution, and movement of assigned pharmaceutical processes into manufacturing, as well as ongoing process performance.
Essential Duties And Responsibilities
Include the following. Other duties may be assigned.
Acts as a single point of contact for implementation of a process in the manufacturing areas.
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
Bachelor’s degree (BS) from a 4-year college; or 5 years related experience in Chemical or Pharmaceutical Manufacturing (GMP preferred) and/or training; or equivalent combination of education and experience.
Language Skills
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, 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 apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to tasks such as frequency distribution; determination of test reliability and validity; analysis of variance; correlation techniques; sampling theory; and factor analysis; etc.
REASONING ABILITY
Ability to define problems, collect data, establish facts, and draw valid conclusions. 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 frequently required to stand, sit, and talk or hear. The employee is occasionally required to walk; work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. 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 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
The Process Implementation Specialist acts as the single point of contact for implementation of one or more chemical manufacturing processes within the Corden Pharma Boulder and Corden Pharma Colorado (CPB and CPC) manufacturing areas to ensure schedule adherence and right the first time. In this role, the Process Implementation Specialist is responsible for the coordination, execution, and movement of assigned pharmaceutical processes into manufacturing, as well as ongoing process performance.
Essential Duties And Responsibilities
Include the following. Other duties may be assigned.
- Establishes and maintains strong, transparent, and effective day-to-day working relationships between Manufacturing, R&D, internal support, regulatory groups, and CPC customers related to assigned products
- Executes all startup activities for chemical process in their area to ensure schedule adherence
- Assists Technical Team with defining process equipment and process training
- Generates change control documents, process and equipment design reviews, updates drawings and P&IDs, and completes change control closure
- Works with Maintenance and Operations to ensure all maintenance activities are scheduled and completed
- Assists Technical Team to ensure cleaning development can be performed effectively and efficiently
- Generates Cleaning Procedures and Cleaning Protocols. Provides training and guidance to Operations on the cleaning/changeover plans and priorities
- Assists with the generation of qualification documents to ensure effective and efficient execution
- Ensures the plant or process areas have the necessary equipment to perform changeovers and operations. Procures equipment and supplies as needed
- Communicates with peers and management to ensure that priorities are adequately defined and coordinated
- Assists with investigation into deviations and implements resulting CAPAs
- Participates in process and equipment PHAs
- Executes roll-out of manufacturing processes to the appropriate plant
- Represents Manufacturing for project design work and implementation to ensure new systems meet operational requirements regarding EH&S and efficient operations, while meeting budgetary requirements
- Ensures that documentation is issued in a timely fashion and is completed within acceptable timelines. This includes change control, cleaning documents, training information, safety procedures shutdowns, project preparations, and specialized operating procedures (as needed)
- Implements and maintains adherence to all company policies concerning Environmental, Health & Safety; Quality; and Human Resources
Acts as a single point of contact for implementation of a process in the manufacturing areas.
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
Bachelor’s degree (BS) from a 4-year college; or 5 years related experience in Chemical or Pharmaceutical Manufacturing (GMP preferred) and/or training; or equivalent combination of education and experience.
Language Skills
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, 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 apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to tasks such as frequency distribution; determination of test reliability and validity; analysis of variance; correlation techniques; sampling theory; and factor analysis; etc.
REASONING ABILITY
Ability to define problems, collect data, establish facts, and draw valid conclusions. 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 frequently required to stand, sit, and talk or hear. The employee is occasionally required to walk; work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. 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.
- Ability to work chemical process areas as assigned
- Excellent understanding of Chemical or Pharmaceutical Manufacturing
- Results oriented approach to process performance
- Strong leadership, delegation, verbal, and written communication skills
- Ability to build relationships and influence and motivate others
- Ability to achieve results through the positive direction of others
- Technical expertise in the practices and technologies used in assigned manufacturing area; and the ability to use these skills in active projects
- Basic knowledge of Chemical Processing, Plant Equipment, and Infrastructure
- Analytical problem-solving skills, including the execution of LEAN Operational Excellence Systems where applicable
- Familiarity with investigation and incident/deviation response tools (e.g., 6M, 5 Whys, Fishbone), CAPA Management, and team-based problem resolution
- Working knowledge of regulatory compliance issues in pharmaceutical manufacturing
- Planning, implementation, and follow-up skills
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 : $70,385 - $82,643
