What are the responsibilities and job description for the Principal Microbiologist 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.
Corden Pharma 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
Provide Microbiology expertise while developing or enhancing the programs around environmental monitoring, GMP cleaning requirements for Graded rooms, gowning, and water systems. Must have experience contributing or creating contamination control strategies based on the requirements of Annex 1.
Essential Duties And Responsibilities
May manage people.
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 their knowledge, training, ability, and experience.
Quality Responsibilities
Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPC’s Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company.
cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.
Qualifications
To perform this job successfully, an individual must have a strong knowledge of microbiology, contamination control, environmental monitoring, gowning, disinfectant efficacy, GMP water systems, and Annex 1. This individual must be adept at speaking to clients and regulatory agencies, technical writing, and training others on microbiology concepts.
EDUCATION And/or EXPERIENCE
Bachelor's Degree (BA) from a four-year college or university or an advanced degree. Ten years in a pharmaceutical setting with experience writing procedures and setting up systems related to microbiology concepts.
Language Skills
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write detailed procedures outlining microbiology programs. Ability to speak effectively before groups of clients, regulatory agencies, and other employees.
Mathematical Skills
Ability to calculate figures and amounts such as proportions, percentages, area, and volume. Ability to apply concepts of basic algebra.
REASONING ABILITY
Ability to solve 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 regularly required to work with hands and talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to 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 occasionally exposed to fumes or airborne particles, low levels of toxic or caustic chemicals, and outside weather conditions. 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 necessities.
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.
Corden Pharma 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
Provide Microbiology expertise while developing or enhancing the programs around environmental monitoring, GMP cleaning requirements for Graded rooms, gowning, and water systems. Must have experience contributing or creating contamination control strategies based on the requirements of Annex 1.
Essential Duties And Responsibilities
- Deep understanding of microbiological techniques, analytical methods, and associated equipment
- Provides guidance on subjects related to microbiological principles
- Creates programs and procedures related to environmental monitoring, contamination control, gowning, disinfectant efficacy/cleaning, and GMP water monitoring
- Attends client meetings and serves as the primary expert on microbiological requirements for new and legacy structures
- May manage people
- Participates in client and regulatory audits/inspections
- May assist with deviation investigations and/or own CAPAs
- Assists with gowning qualifications, as needed
- Trains others, as needed, on microbiological concepts
May manage people.
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 their knowledge, training, ability, and experience.
Quality Responsibilities
Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPC’s Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company.
cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.
Qualifications
To perform this job successfully, an individual must have a strong knowledge of microbiology, contamination control, environmental monitoring, gowning, disinfectant efficacy, GMP water systems, and Annex 1. This individual must be adept at speaking to clients and regulatory agencies, technical writing, and training others on microbiology concepts.
EDUCATION And/or EXPERIENCE
Bachelor's Degree (BA) from a four-year college or university or an advanced degree. Ten years in a pharmaceutical setting with experience writing procedures and setting up systems related to microbiology concepts.
Language Skills
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write detailed procedures outlining microbiology programs. Ability to speak effectively before groups of clients, regulatory agencies, and other employees.
Mathematical Skills
Ability to calculate figures and amounts such as proportions, percentages, area, and volume. Ability to apply concepts of basic algebra.
REASONING ABILITY
Ability to solve 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 regularly required to work with hands and talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to 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 occasionally exposed to fumes or airborne particles, low levels of toxic or caustic chemicals, and outside weather conditions. 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 necessities.
- Strong understanding of microbiological concepts
- Ability to independently create programs related to microbiological concepts
- Ability to lead and or participate in risk assessments
- Strong writing skills
- Understanding of FDA guidelines, ISO standards, Annex 1, and other regulatory requirements related to microbiology
- Math, reading, and comprehension skills
- Good communication and computer skills
- Commitment to QHER Principles
- Ability to work closely with team members to a common goal
- Attention to detail
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 : $110,000 - $130,000
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