---
title: 'Commercial Quality Control Manager at Serán BioScience'
canonical: 'https://feeny.ai/job/commercial-quality-control-manager-seran-bioscience-bend-g42k9exbwvwy'
type: 'job'
last_seen: '2026-09-11'
---

# Commercial Quality Control Manager at Serán BioScience

- **Company:** Serán BioScience
- **Location:** Bend, OR
- **Employment:** full-time
- **Work type:** onsite
- **Posted:** 2026-07-29
- **Last confirmed live:** 2026-09-11
- **Apply:** https://jobs.lever.co/seranbio/a811ae32-4a90-4f4c-ac3e-624d20e53bd3

## Job description

Serán is seeking a Commercial Quality Control Laboratory Manager who is responsible for leading the daily operations of the Commercial Quality Control Laboratory in support of commercial manufacturing, product release, stability testing, and ongoing GMP compliance. This position ensures analytical testing is performed accurately, efficiently, and in compliance with current Good Manufacturing Practices (cGMP), ICH guidelines, FDA regulations, and company procedures. The Commercial QC Laboratory Manager provides leadership to QC laboratory personnel, oversees laboratory scheduling and resource allocation, manages investigations, laboratory deviations, OOS/OOT events, change controls, and CAPAs, and partners closely with Manufacturing, Supply Chain, Analytical Development, and Quality Assurance to ensure timely release of commercial products. This role is responsible for maintaining inspection readiness, driving operational excellence, developing laboratory personnel, and fostering a culture of quality, accountability, continuous improvement, and customer focus.

Duties/Responsibilities

- Recruit, interview, hire, onboard, train, and develop Quality Control laboratory personnel.
- Provide daily leadership, coaching, mentoring, and technical guidance to laboratory staff.
- Establish performance expectations and conduct timely performance evaluations.
- Manage daily operations of the Commercial Quality Control laboratory.
- Ensure timely execution of release, in-process, raw material, cleaning verification, and stability testing
- Coordinate laboratory scheduling and prioritize testing activities to support manufacturing and customer commitments.
- Monitor laboratory workload, staffing, and turnaround times to ensure on-time product disposition.
- Review laboratory metrics and implement improvements to increase efficiency and effectiveness.
- Ensure laboratory documentation is accurate, complete, and compliant with ALCOA++ data integrity principles
- Always maintain inspection readiness.
- Lead laboratory investigations (OOS/OOT, deviations, atypical results) ensuring timely completions.
- Support internal audits, client audits, and regulatory inspections, maintaining compliance with FDA, EMA, ICH, USP, EP, and other applicable regulatory requirements.
- Support commercial batch release through timely analytical testing and documentation.
- Oversee stability program execution including protocol implementation, sample management, testing, and reporting.

Required Skills & Abilities

- Strong working knowledge of cGMP, FDA, ICH, USP, and data integrity requirements.
- Strong understanding of commercial pharmaceutical manufacturing.
- Experience managing analytical testing supporting commercial product release.
- Experience leading laboratory investigations including OOS, OOT, deviations, CAPAs, and change controls.
- Strong technical knowledge of chromatographic and analytical instrumentation.
- Experience with laboratory electronic systems including LIMS, Empower, NuGenesis, or equivalent.
- Excellent scientific writing and technical documentation skills.
- Strong organizational and project management abilities.
- Excellent verbal and written communication skills.
- Strong customer service and relationship management skills.
- Demonstrated ability to manage multiple priorities while meeting aggressive timelines.
- Strong analytical and critical thinking skills.
- Excellent leadership, coaching, and mentoring abilities.
- Demonstrated commitment to continuous improvement and operational excellence.

Education and Experience

- Bachelor’s degree in chemistry, physics, engineering, or related scientific discipline.
- Advanced degree or equivalent experience preferred.
- 5-10 years of relevant experience in laboratory.
- Requires 5 years of GMP experience.
- Previous management/supervisor experience in commercial Quality Control preferred.
- Experience supporting FDA, client, and regulatory inspections preferred.

Physical Requirements

- Prolonged periods of sitting at a desk and working on a computer
- Must be able to lift up to 15 pounds at time
- Adheres to predictable and consistent in-person attendance

Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.

Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Benefits Summary: Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.

The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701

## About Serán BioScience

## Company Overview
- **One-liner**: Serán BioScience is a science-driven drug development partner providing integrated formulation, particle engineering, and clinical manufacturing services to pharmaceutical and biotechnology companies.
- **Entity Type**: Private (Privately Held)
- **Headquarters**: Bend, Oregon, United States
- **Founded**: 2016
- **Founders**: Dr. Smithey (President, CEO, and Co-founder)

## Core Business
- **Primary Industry**: Biotechnology / Drug Development (Contract Development and Manufacturing Organization – CDMO)
- **Target Customers**: B2B – Pharmaceutical and biotechnology companies (from preclinical to commercial stage)
- **Mission**: To provide optimized drug development and manufacturing services for clients, from discovery to the clinic, using a science-first approach to accelerate medicines to patients.

## Products & Services
- **Preformulation Services**: Physicochemical characterization and early feasibility studies to guide formulation strategy.
- **Formulation Development**: Design of robust formulations for poorly soluble compounds using spray drying, hot melt extrusion, fluid bed processing, granulation, and solid dosage forms (tablets, capsules, multiparticulates).
- **Particle Engineering**: Custom-built spray dryers capable of producing nano-to-micro particles; expertise in spray-dried dispersions and engineered particles for inhalation.
- **Clinical Manufacturing**: cGMP manufacturing of clinical trial materials (suspensions, capsules, tablets) with on-site ICH stability storage.
- **Commercial Manufacturing**: A 100,000 sq ft commercial manufacturing campus under construction, including large-scale spray drying for late-stage clinical and commercial supply.
- **Quality Control Laboratory**: Full release, stability, and microbial testing capabilities.

## Market Standing
- **Valuation/Market Cap**: Not publicly available
- **Key Metric**: Total Funding – Not disclosed; Headcount of 146 employees (+0.6% YoY as of latest LinkedIn data)
- **Notable Investors/Partners**: Not publicly disclosed
- **Growth Signals**: Constructing a 100,000 sq ft commercial manufacturing facility; expanding team to over 200 members; adding new development facilities and quality control labs; LinkedIn follower growth of +29.1% year-over-year.

## Competitive Advantages
- **Science-First Approach**: Employs predictive design tools, novel chemistry, and advanced analytical methods from the earliest stages to de-risk development.
- **Particle Engineering Leadership**: Decades of experience with poorly soluble compounds; proprietary spray drying and particle engineering technologies (nano-structures to micro-particulates).
- **End-to-End Support**: Integrated services from preformulation through commercial manufacturing, reducing handoffs and timelines.
- **Right From the Start™ Methodology**: Parallel development of drug product intermediates and final dosage forms to accelerate programs.

## Strategic Focus
- **Commercial Scale-Up**: Investing in a dedicated commercial manufacturing campus to support clients’ late-stage and marketed products.
- **Technology Expansion**: Continuously expanding technical capabilities (spray drying, hot melt extrusion, fluid bed processing) and facility footprint.
- **Talent Acquisition**: Growing the team of scientists, engineers, and support staff to serve an increasing pipeline of complex drug molecules.

## Why Work Here
- **Culture**: Collaborative, respectful, and fun environment where every role contributes to delivering novel therapies. Emphasis on mentoring and continuous learning.
- **Work-Life Balance**: Central Oregon lifestyle with outdoor recreation access; standard business hours (with alternative shifts in manufacturing/QC/QA).
- **On-Site Requirement**: All employees are expected to work on the Bend campus; remote flexibility considered on a case-by-case basis.
- **Benefits**: Paid time off, employer retirement contributions (no match or vesting required after 90 days), fully funded medical/dental/vision for employee and household, basic life and long-term disability, Employee Assistance Program.
- **Ideal Applicant**: Scientific background with GLP/GMP knowledge; inquisitive problem-solver who follows SOPs and collaborates toward common goals.

## Sources
1. [seranbio.com](https://www.seranbio.com/about)
2. [linkedin.com](https://linkedin.com/company/seran-bioscience)
3. [seranbio.com](https://www.seranbio.com/careers)
4. [seranbio.com](https://www.seranbio.com/?portfolioCats=34%2C23%2C29%2C35%2C22%2C24%2C30%2C25%2C28%2C31)
5. [jobs.lever.co](https://jobs.lever.co/seranbio)

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