--- title: 'Director of Quality Control (Commercial) at Serán BioScience' canonical: 'https://feeny.ai/job/director-of-quality-control-commercial-seran-bioscience-bend-wy13cn9cxgz5' type: 'job' last_seen: '2026-10-23' --- # Director of Quality Control (Commercial) at Serán BioScience - **Company:** Serán BioScience - **Location:** Bend, OR - **Employment:** full-time - **Work type:** onsite - **Posted:** 2026-10-22 - **Last confirmed live:** 2026-10-23 - **Apply:** https://jobs.lever.co/seranbio/feff174c-2afd-42a3-8785-4703a7efb7bd ## Job description The Director, Commercial Quality Control is responsible for leadership, oversight, and strategic direction of Quality Control operations supporting commercial and late-stage clinical manufacturing. The role ensures that laboratory activities, analytical testing programs, personnel, systems, and facilities are compliant with applicable regulatory requirements and capable of supporting commercial product release, raw material disposition, stability programs, in-process testing, cleaning verification activities, and continued process verification initiatives. This role is responsible for ensuring that Quality Control laboratories are appropriately staffed, qualified, resourced, and inspection-ready while maintaining a strong culture of data integrity, operational excellence, and continuous improvement. This position establishes and maintains effective working relationships with internal stakeholders, clients, contract laboratories, equipment service providers, suppliers, and regulatory agencies. The Director of Commercial Quality Control also serves as a key Quality leader during regulatory inspections, client audits, and internal quality reviews, and drives continuous improvement initiatives related to quality control. Leader Responsibilities - Leads and develops a high-performing Quality Control organization - Provides mentoring, coaching, and professional development for technical staff; provides constructive and timely performance evaluations, and handles discipline of employees in accordance with company policy - Establish clear departmental goals aligned with organizational quality and operational objectives - Conducts performance reviews and ensure staff maintain appropriate training and GMP qualifications - Fosters a culture of quality ownership, compliance, and continuous improvement - Oversees daily workflow of the department Commercial Quality Control Operations - Lead Quality Control activities supporting commercial and late-stage clinical manufacturing. - Ensure timely and compliant release testing of raw materials, intermediates, bulk products, and finished drug products. - Ensure laboratory activities support manufacturing schedules and customer commitments. - Maintain laboratory capacity planning and resource forecasting to support business growth. - Establish and monitor departmental performance metrics and key performance indicators. Stability Program Management - Oversee commercial and late phase clinical stability programs. - Ensure ongoing stability commitments are executed according to approved protocols. - Review and approve stability data, trending reports, and investigation outcomes. - Ensure timely reporting of stability results and product quality concerns. Raw Material Program - Direct raw material testing, qualification, and disposition activities. - Ensure appropriate sampling, testing, and release controls are maintained. - Collaborate with Supply Chain and Supplier Quality functions regarding material quality issues. - Support supplier qualification and material risk assessment activities. In-Process Testing & Manufacturing Support - Ensure timely in-process testing support for manufacturing operations. - Partner with Manufacturing and Process Sciences teams to support process monitoring and continued process verification. - Support PPQ campaigns and commercial validation activities through laboratory testing services. Cleaning Verification Program - Oversee analytical support for equipment cleaning verification programs. - Ensure cleaning verification swab and rinse testing is performed according to approved procedures and validated analytical methodologies. - Support cleaning validation and continued cleaning verification strategies. - Collaborate with Manufacturing, Validation, and Quality Assurance regarding cleaning program effectiveness and compliance. Laboratory Operations & Asset Management - Direct laboratory operations including scheduling, workflow management, and capacity planning. - Oversee laboratory instrumentation lifecycle management. - Ensure timely calibration, qualification, maintenance, repair, and replacement of laboratory equipment. - Manage vendor relationships supporting laboratory equipment and services. - Coordinate instrument service schedules to minimize operational disruptions. - Ensure laboratory facilities remain inspection-ready and compliant. Contract Laboratory Oversight - Serve as Quality Control owner for external laboratory relationships. - Oversee analytical testing agreements and outsourced testing activities. - Monitor laboratory performance metrics and service quality. - Ensure appropriate data review and disposition of externally generated data. Laboratory Compliance & Data Integrity - Maintain GMP-compliant laboratory systems and practices. - Ensure data integrity principles are implemented and maintained in accordance with ALCOA+ requirements. - Support internal audits, client audits, and regulatory inspections. - Lead laboratory investigation activities related to OOS, OOT, atypical results, laboratory deviations, and data events. - Drive timely and effective corrective and preventive actions. Method Lifecycle Management - Partner with Analytical Development and Validation teams to support method transfer, qualification, verification, and validation activities. - Ensure control strategies, specifications, and analytical procedures remain fit for intended use throughout the product lifecycle. - Support compendial assessments and implementation of evolving pharmacopeial requirements. Quality Systems & Regulatory Compliance - Ensure compliance with applicable FDA, EMA, ICH, USP, and cGMP requirements. - Maintain inspection readiness across all laboratory operations. - Support regulatory submissions and agency interactions as required. - Participate in Management Review and Quality Council initiatives. - Lead continuous improvement initiatives to enhance laboratory effectiveness and compliance robustness. Required Skills & Abilities - General knowledge of oral solid dosage manufacturing processes preferred - Expert knowledge of GMP QC operations for late-phase and commercial programs - In-depth understanding and application of cGMP principles, concepts, practices, and standards - Experience with regulatory inspections by the FDA and EU authorities - Ability to influence diverse stakeholders and drive accountability and decision-making cross functionally - Interest in developing and implementing new technologies. - Demonstrated ability to partner with other functional groups to achieve business objectives - Experience organizing and managing work responsibilities while working independently with minimal oversight - Time and project management skills with the ability to multi-task and meet deadlines - Excellent verbal and written communication skills - Excellent organizational skills and attention to detail - Communicate effectively and maintain productive relationships with coworkers, clients, and other contacts outside of the company - Accepts feedback from a variety of sources and constructively manages conflict - Strong analytical and problem-solving skills - Proven ability to lead organizations - Ability to prioritize tasks and to delegate when appropriate - Proficient with Microsoft Office Suite or related software. Education & Experience - B.S. / M.S. in chemistry, pharmaceutical sciences, or related discipline with at least 5 years QC management experience and 10+ years related experience preferred (CDMO experience preferred) - Demonstrated continued growth and responsibility in management and leadership experience. - Expert level knowledge of drug product and raw material release and stability testing, industry expectations, methods, and systems for pharmaceutical products. - Expert level knowledge of Industry Compendia (USP/Pharm EU, etc.). - Working knowledge of regulatory requirements including cGMP, FDA/EU, ICH and USP. - Requires 10+ years of GMP experience. Physical Requirements - Prolonged periods of sitting or standing at a desk and working on a computer. - Must be able to lift up to 15 pounds at a time - Adheres to consistent and predictable 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](https://www.bing.com/ck/a?!&&p=89945e36682bf05113ab303fd3f1c9a15c6f7e74683fcc8c429813f125b36844JmltdHM9MTczMzI3MDQwMA&ptn=3&ver=2&hsh=4&fclid=076ddb4a-efd8-6d3a-2ff2-cfdaee446c2a&u=a1L21hcHM_Jm1lcGk9MTI3fn5Vbmtub3dufkFkZHJlc3NfTGluayZ0eT0xOCZxPVNlciVDMyVBMW4lMjBCaW9zY2llbmNlJTJDJTIwTExDJnNzPXlwaWQuWU44NzN4MTUzMDIzMTAwNDQ1OTA4OTg5NTkmcHBvaXM9NDQuMDg5NzE0MDUwMjkyOTdfLTEyMS4yOTE2NDEyMzUzNTE1Nl9TZXIlQzMlQTFuJTIwQmlvc2NpZW5jZSUyQyUyMExMQ19ZTjg3M3gxNTMwMjMxMDA0NDU5MDg5ODk1OX4mY3A9NDQuMDg5NzE0fi0xMjEuMjkxNjQxJnY9MiZzVj0xJkZPUk09TVBTUlBM&ntb=1) ## 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) ## Other roles at Serán BioScience - [Manager, cGMP Training & Learning Programs](https://feeny.ai/job/manager-cgmp-training-learning-programs-seran-bioscience-bend-yq4zy81mnhtq) — Bend, OR - [Associate Director, Quality Systems and Compliance](https://feeny.ai/job/associate-director-quality-systems-and-compliance-seran-bioscience-bend-ht2tjg9bbq5k) — Bend, OR - [Operations Supervisor (Swing Shift)](https://feeny.ai/job/operations-supervisor-swing-shift-seran-bioscience-bend-662hrkbrv5m5) — Bend, OR - [Staff Accountant with AR Emphasis](https://feeny.ai/job/staff-accountant-with-ar-emphasis-seran-bioscience-bend-jtaphqab2emv) — Bend, OR - [Manufacturing Production Planner](https://feeny.ai/job/manufacturing-production-planner-seran-bioscience-bend-n3pd6ptks4zn) — Bend, OR - [Quality Control Specialist I, Laboratory Instrumentation I](https://feeny.ai/job/quality-control-specialist-i-laboratory-instrumentation-i-seran-bioscience-bend-jfeq1jjsawrb) — Bend, OR - [Commercial Quality Control Chemist I](https://feeny.ai/job/commercial-quality-control-chemist-i-seran-bioscience-bend-q49tynmr9j0h) — Bend, OR - [Commercial Quality Control Chemist II](https://feeny.ai/job/commercial-quality-control-chemist-ii-seran-bioscience-bend-q523axeg2wnk) — Bend, OR - [Senior Controls and Calibration Technician](https://feeny.ai/job/senior-controls-and-calibration-technician-seran-bioscience-bend-myj7qyzwcjm0) — Bend, OR - [Operations Technician, Swing Shift](https://feeny.ai/job/operations-technician-swing-shift-seran-bioscience-bend-ar7sj94yyh2m) — Bend, OR