Quality Control Manager, Environmental Monitoring and Microbiology at Serán BioScience

Bend, Oregon, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Regulatory knowledge and experience in a pharmaceutical manufacturing environment
GMP leadership experience with a desire to build programs, systems, and teams
Comprehensive knowledge of quality systems, cGMP, regulatory and industry standards at all phases of drug development with prior experience through commercialization
Proven experience developing budgets, monitoring, and escalating variances
Experience and/or knowledge of process validation lifecycle approach for biological product (preferred)
Excellent knowledge of FDA/EU/ICH/CDN/AUS guidelines and inspections
Understanding of aseptic processing, environmental/utility monitoring, clean room qualification, and microbiological testing
Maintain current knowledge of new technologies and potential applications
Practical knowledge and understanding of implementing phase appropriate procedures and processes
Excellent verbal and written communication skills
Excellent organizational skills and attention to detail
Accepts feedback from a variety of sources

Responsibilities

Ensures that EM & Microbiology Systems and practices are developed and implemented in accordance with the requirements of GMP
Represents the site in client interactions for all questions related to Microbiology testing or the Environmental Monitoring program
Represents the site in audits and inspections related to Microbiology testing or Environmental Monitoring program
Oversees daily workflow of the department and direct reports to ensure deadlines and metrics are achieved
Supervises Microbiology assay and EM teams, acting as an advisor to team members when determining how to meet schedules or resolve technical problems
Review testing and laboratory records for accuracy and compliance with cGMP and company policies and procedures
Develops site Environmental and Utility monitoring programs and policies, ensuring sampling plans are up to date and executed on schedule
Host monthly trend meetings, sharing trend information with the site Quality Council, and identifying and escalating adverse trends
Drives corrective and preventative actions, ensuring work is complete and the site remains in a state of control and compliance
Leads environmental excursion investigations
Monitors EM & Microbiology resource capacity and provides feedback to QC management, program management, and production planners when capacity constraints exist
Responsible for building and improving quality systems
Controls and executes deviations
Oversees Corrective/Preventive Action (CAPA) plans
Monitors and reports Out-of-Specification/Out-of-Trend (OOS/OOT) results
Keep management apprised of EM/Micro activities and provide input and recommendations as appropriate
Preparation and support for internal audits
Responsibilities may increase in scope to align with company initiatives
Performs other related duties as assigned

Skills

GMP

Environmental Monitoring

Microbiology

FDA regulations

EU regulations

Quality Control

Laboratory Management

Audits

Inspections

Microbiology Testing

Serán BioScience

Contract development and manufacturing for pharmaceuticals

About Serán BioScience

Serán BioScience specializes in providing drug development and manufacturing services as a Contract Development and Manufacturing Organization (CDMO). They offer a variety of services, including preformulation, formulation development, dosage form development, spray drying, and particle engineering. Their operations adhere to current Good Manufacturing Practice (cGMP) standards, ensuring high quality and safety in their products through rigorous analytical quality control. Serán BioScience serves a wide range of clients, from small biotech startups to large pharmaceutical companies, and is distinguished by its flexibility in tailoring services to meet specific client needs. The company's goal is to enhance the efficiency and effectiveness of drug development processes for their clients.

Bend, OregonHeadquarters

2016Year Founded

$194.5MTotal Funding

GROWTH_EQUITY_VCCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Paid Vacation

401(k) Retirement Plan

Health Insurance

Life Insurance

Disability Insurance

Mental Health Support

Pet Insurance

Risks

Emerging CDMOs in Asia offer lower-cost services, impacting Serán's market share.

Potential delays in new facility construction could affect expansion plans.

Global talent shortage may hinder recruitment for Serán's expansion.

Differentiation

Serán specializes in advanced drug formulation techniques, including spray drying and particle engineering.

The company offers cGMP manufacturing and analytical quality control services.

Serán's flexibility allows tailored services to meet specific client needs.

Upsides

Serán announced a $200 million strategic growth transaction for expansion.

The company plans to build a new commercial-scale manufacturing facility.

Increased demand for personalized medicine aligns with Serán's formulation expertise.

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