Sr. Microbiologist

Corden Pharma Colorado • Boulder, CO, US, CO

1d • Onsite

About The Position

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. This role 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.

Requirements

• Experience in a GMP microbiology laboratory is required.
• 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.
• 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.
• Ability to calculate figures and amounts such as proportions, percentages, area, and volume.
• Ability to apply concepts of basic algebra.
• 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.
• 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
• 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

Nice To Haves

• Highly motivated, organized, and can work independently.

Responsibilities

• 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior