Sr. Microbiologist

Sr. Microbiologist Corden Pharma Colorado

• 3.0 Boulder, CO Job Details Full-time $85,000
• $100,000 a year 4 hours ago Benefits Wellness program Paid parental leave Health savings account Disability insurance Health insurance Dental insurance Flexible spending account Tuition reimbursement Parental leave Employee assistance program Vision insurance 401(k) matching Life insurance Qualifications Microbiology Report writing Pharmaceutical regulatory compliance GMP Microbiology Math Quality standards in production Algebra Cross-functional collaboration Cross-functional communication Full Job Description CordenPharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging.

With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people's lives. Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.

OUR PEOPLE VISION

We strive for excellence. We share our passion. Together, we make a difference in patients' lives. SUMMARY Performs microbial and environmental monitoring assays, facility qualification, and testing of purified water and cleaning samples. This position will act as a Subject Matter Expert (SME) for one or multiple microbiological programs which requires review of laboratory data, to lead and/or assist in the development and execution of method verification/validation activities, and support commissioning of laboratory instruments. The ideal candidate will be highly motivated, organized, and can work independently. Experience in a GMP microbiology laboratory is required.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned. As required, perform Microbiology sampling and testing according to SOP and following ALCOA+ principles including, but not limited to: Environmental Monitoring (EM) and water Microbiological assays including bioburden, media qualification, culture qualification, and microbial identification Support microbial control of the facility by maintaining aseptic technique while following GMP and ALCOA+ principles during sample collection and testing Promote Operation Excellence principles in the laboratories, including 5S strategies and continuous improvement initiatives Perform equipment preventative maintenance (PM) and other laboratory cleaning tasks as required Act as Subject Matter Expert (SME) on microbiological assays, method qualification, and technical troubleshooting. May also support preparation of quarterly and annual reports Initiate and complete deviations, invalid assay, and laboratory investigations Author, review, and approve procedures, specifications, verification, and validation documents Lead and/or participate in test method transfers and assay validations Support onboarding and qualification of laboratory equipment and GMP software systems Implement change controls, lead investigations, and complete CAPAs in support of GMP operations Train and mentor junior staff Works on moderate to highly complex problems where analysis of situations or data requires an in-depth evaluation of various factors. This role requires attention to detail, organization, and comfort interacting cross-functionally with internal and external partners Performs endotoxin analysis using turbidimetric and gel clot methods on water and product samples Maintains the Micro Lab including supply ordering, sterilization, instrument maintenance, and calibration Attends and participates in QC Team meetings Substantial knowledge of GMP guidelines as well as international regulations pertaining to the production of APIs including, but not limited to USP, EP, JP, EU, ICH, and

FDA LEADERSHIP & BUDGET RESPONSIBILITIES

None.

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 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 (BA) from a 4-year college or university in biology, microbiology, or life sciences field; and 3 years of related experience and/or training; or equivalent combination of education and experience.

LANGUAGE SKILLS

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of an organization.

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 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 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 necessity. Strong math, reading, and comprehension skills Analytical skills and knowledge of general microbiology Mechanical aptitude with lab equipment Support senior level QC Staff Perform basic methods on test samples Good communication skills and computer skills Ability to work closely with team members to a common goal Attention to detail Ability to work on Monday

• Friday, 8:00 am-5:00 pm 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 Parental Leave Tuition Reimbursement Wellness Program Vacation
• Three Weeks 1st Year Vision Insurance

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. This post will expire June 15, 2026