Commercial Quality Control Manager - Commercial Quality Control Laboratory
About the job
- Strong working knowledge of Good Manufacturing Practices, FDA, ICH, USP, and data integrity requirements.
- Strong understanding of commercial pharmaceutical manufacturing, including laboratory development and method transfers.
- Experience implementing Lean and Six Sigma methodologies to reduce waste and improve process reliability.
- Experience managing analytical testing supporting commercial product release.
- Experience leading laboratory investigations, including OOS, OOT, deviations, CAPAs, and change controls.
- Strong technical knowledge of instrument qualifications for chromatographic and analytical instrumentation.
- Experience coordinating with vendors and contractors to support timely and compliant laboratory startup.
- Experience with laboratory electronic systems including LIMS, Empower, NuGenesis, or equivalent.
- Excellent scientific writing and technical documentation skills.
- Strong organizational and project management abilities.
- Strong customer service and relationship management skills.
- Ability to manage multiple projects, work within internal timelines, solve problems, deliver on commitments, and work effectively in a cross-functional team.
- Strong analytical and critical-thinking skills.
- Excellent leadership, coaching, and mentoring abilities.
- Bachelor's degree in chemistry, physics, engineering, or a related scientific discipline.
- Five to ten years of relevant experience in a CDMO laboratory.
- At least five years of GMP experience.
- Ability to lift up to 15 pounds at times.
- Support qualification of the new commercial laboratory, including instrument and facility qualification.
- Collaborate with cross-functional teams to define equipment specifications, user requirements, project timelines, and budgets.
- Develop and execute equipment IQ/OQ/PQ protocols in alignment with site validation master plans and project timelines.
- Drive commercial launch readiness activities, including method qualifications, validations, GMP documentation, and technology transfer from development to commercial operations.
- Collaborate with multidisciplinary teams to complete change controls, deviation investigations, and CAPAs.
- Collaborate with Facilities and Maintenance to establish preventive maintenance schedules.
- Collaborate with Information Technology to complete computer system validations aligned with 21 CFR Part 11 requirements.
- Partner with Validation, Quality Assurance, and Manufacturing to meet regulatory requirements.
- Maintain inspection readiness for internal audits, client audits, and regulatory inspections, ensuring compliance with FDA, EMA, ICH, USP, EP, and other applicable requirements.
- Lead laboratory investigations involving OOS, OOT, deviations, and atypical results, ensuring timely completion.
- Manage daily operations of the Commercial Quality Control Laboratory.
- Support commercial batch release through timely release, in-process, raw-material, cleaning-verification, stability-testing, and documentation activities.
- 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.
- Oversee stability-program execution, including protocol implementation, sample management, testing, and reporting.
- 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.
- Address employee performance issues and discipline in accordance with company policies.
- Promote employee engagement, accountability, teamwork, and continuous improvement.
- Ensure adequate staffing to support commercial manufacturing and laboratory operations.
- Knowledge of global regulatory requirements, including FDA, MHRA, and EMEA.
- An advanced degree or equivalent experience.
- Demonstrated commitment to continuous improvement and operational excellence.
About the company
Serán Bioscience is a contract development and manufacturing organization (CDMO) that helps pharmaceutical companies develop and manufacture drugs. It provides preformulation, formulation and dosage form development, spray drying and particle engineering, and cGMP manufacturing and analytical quality control to move drugs from concept to scalable production. Its services revolve around designing and optimizing drug formulations and production processes, with rigorous analytical testing to ensure safety and quality. It differentiates itself with a flexible, client-tailored approach and a broad toolkit, especially in spray drying and particle engineering, all under strict cGMP standards. Its goal is to help clients—from startups to large pharma—bring safe, effective therapies to market efficiently and reliably.
Company Size
51-200
Company Stage
Growth Equity (Venture Capital)
Total Funding
$200M
Headquarters
Bend, Oregon
Founded
2016
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Simplify's Take
What believers are saying
- Biospring Partners led Serán’s September 29, 2026 growth investment.
- Serán’s new commercial facility targets completion in Q3 2027.
- Management plans to add 150 employees as demand for spray drying keeps rising.
What critics are saying
- Bend concentration makes fires, permits, and hiring shocks existential if 2027 ramps slip.
- Q3 2027 commercial startup demands flawless validation, or Biospring’s $200 million thesis breaks.
- Lonza and Catalent pressure margins once Serán enters commercial-scale oral-solid manufacturing.
What makes Serán BioScience unique
- Serán pairs spray drying expertise with OEB4 commercial manufacturing in Bend.
- Its 2026 campus links development, packaging, serialization, and cold-chain distribution.
- The company specializes in complex oral and pulmonary particle-engineering programs.
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Benefits
Paid Vacation
401(k) Retirement Plan
Health Insurance
Life Insurance
Disability Insurance
Mental Health Support
Pet Insurance
Growth & Insights and Company News
6 month growth
-3%1 year growth
-4%2 year growth
12%Biospring Partners leads investment in Serán Bioscience. Biospring Partners made an investment in Serán Bioscience, alongside existing investors Vivo Capital, Bain Capital Life Sciences and Serán's executive leadership. The investment will support Serán's expansion from clinical development and manufacturing into commercial-scale services, including completion of a new commercial manufacturing facility scheduled for the third quarter of 2027. The new facility is intended to address growing customer demand for particle engineering and commercial manufacturing capabilities, including spray drying and nano-milling. Bend, Ore.-based Serán Bioscience is a contract development and manufacturing organization providing development, analytical and manufacturing services to pharmaceutical and biotechnology companies. The company has more than 200 employees, including over 150 scientists and engineers, and plans to add as many as 150 employees as its commercial expansion progresses. Incline Equity Partners Invests in The Conrad Company TCC provides pneumatic, hydraulic, automation, lubrication and compressed-air products and services to a range of industrial customers. To read the entire story, you must be logged in. Greenbriar Equity Group Buys Spectrum Control from AEA Investors Spectrum Control develops RF and microwave technologies for aerospace, defense, space and commercial applications. To read the entire story, you must be logged in. Kestra Financial Adds Ecclesiastes Wealth Partners The Richardson, Texas-based firm's affiliated financial professionals oversee approximately $550 million in client assets. To read the entire story, you must be logged in. H.I.G. Capital Buys U.K. Fulfilment Provider Torque Torque provides outsourced fulfillment and supply chain services to consumer brands across e-commerce, retail and wholesale channels. To read the entire story, you must be logged in.
Seran Bioscience boosts spray drying capabilities. BEND, Ore., Sept 29 - Serán Bioscience ("Serán" or "the Company"), a leading contract development and manufacturing organization (CDMO) specializing in development, analytical and manufacturing solutions for pharmaceutical and biotechnology companies, today announced a growth investment led by Biospring Partners with continued participation from existing investors Vivo Capital, Bain Capital Life Sciences ("Bain Capital"), as well as Serán's executive leadership. The new capital commitment underscores Serán's sustained commercial momentum and business success, empowering the Company to accelerate its strategic expansion across clinical to commercial services. In direct response to growing client demand for industry leading capabilities in particle engineering and state-of-the-art commercial-scale manufacturing technologies, Serán is aggressively expanding its service offerings to provide enabling and accelerated solutions for clients from early development to commercial supply. Business & Industrial A centerpiece of Serán's expansion strategy is the on-schedule construction of its new state-of-the-art commercial facility to be completed in 3Q 2027. Purpose-built to meet the industry's most demanding technical specifications, the multi-suite facility will support OEB4 manufacturing for oral, pulmonary, and other delivery modalities with commercial-scale particle engineering solutions, including spray drying, and nano-milling. In addition, this new facility will also provide comprehensive finished dose capabilities including granulation, tableting, coating, encapsulation, and specialized dry powder filling for inhalation products across immediate and modified release profiles. This greenfield expansion seamlessly integrates with Serán's recently completed adjacent packaging and logistics facility which will provide fully validated packaging, labeling, unit-level serialization, and global cold-chain distribution. Discover more Businesses Media Outreach Services "This investment is a significant milestone in Serán's evolution as we rapidly scale our clinical manufacturing operations to support launches of new medicines, as well as serve new clients seeking a state-of-the-art commercial manufacturing partner," said Dan Smithey, Co-Founder and CEO of Serán. "With the invaluable backing of Biospring Partners, alongside our long-standing partners at Bain Capital and Vivo Capital, we are well-positioned to complete our greenfield commercial facility on schedule and deliver seamless, life-changing therapies from early-phase discovery through commercial launch." "We're excited to partner with Serán and support the company's continued growth. This investment fuels Serán's growing clinical business in tandem with its transition to commercial-scale manufacturing. The company has an outstanding track record of quality and speed, and the team is widely recognized as a scientific and operational leader in spray drying," said Socrates Zacharias, a Principal at Biospring Partners. "As the industry develops increasingly complex oral drugs, we're seeing growing demand for spray drying capabilities. Serán is exceptionally well-positioned to help pharma and biotech companies bring these therapies to patients." Business & Industrial Gaurav Aggarwal, a Managing Partner at Vivo Capital, said: "We are now realizing the vision we laid out years ago with Dan of adding commercial capabilities to create a true end-to-end offering. I know I speak for my Vivo colleagues and for our partners at Bain when I say we are excited about the deep experience Biospring brings, which will help the company in its next phase of growth." Serán has over 200 team members, of which more than 150 are scientists and engineers and will hire as many as 150 additional employees as the commercial expansion progresses, resulting in the creation of a 200,0000 ft[2] campus in Bend, Oregon.
Biospring Partners leads growth investment in spray drying CDMO Serán Bioscience. Bend, Oregon-based Serán Bioscience provides development, analytical and clinical manufacturing services to pharmaceutical and biotechnology companies. 31 minutes ago
Building Blocks: Serán Bioscience facility. PROJECT: Serán Bioscience commercial manufacturing facility OWNER: Serán Bioscience PROJECT DESCRIPTION: Serán Bioscience LLC, in collaboration with Mortenson, is creating a CGMP (Current Good Manufacturing Process) facility in Bend. Slated to open in fall 2027, it will be the third building and centerpiece of Serán's new 100,000-square-foot commercial campus. The team is employing a progressive design-build approach for the project. A topping-out ceremony for the new building was held earlier this month, marking the transition from structural work to interior build-out. Approximately four acres of the 14-acre campus are being used, allowing room for future development. The latest building marks a milestone in Serán's mission to provide fully integrated support, including preclinical services, clinical trial product manufacturing, and commercial-scale production of modern therapeutics. Last fall, Serán completed two new warehouse and light manufacturing buildings totaling 50,000 square feet. These spaces support critical materials handling, packaging, labeling and logistics functions. The commercial site will operate as an extension of the company's 90,000-square-foot clinical development and manufacturing campus nearby. "Building Blocks" spotlights noteworthy projects either under construction or approaching the start of construction. To submit a project for consideration, please visit: djcoregon.com/building-blocks.
Serán Bioscience holds topping-out ceremony for new NE Bend manufacturing facility. BEND, Ore. (KTVZ) - Serán Bioscience, LLC, in collaboration with leading developer and design-builder Mortenson, hosted a topping-out ceremony on Thursday to celebrate the construction progress of a new commercial-scale cGMP pharmaceutical and biotech manufacturing facility in northeast Bend. The topping-out ceremony marks the transition from structural construction to interior build-out. Slated to open in the second quarter, the facility on NE Triton Place is the third building and the centerpiece of Serán's new 100,000-square-foot commercial manufacturing campus, the company said in a news release that continues in full below: The campus positions Bend as a growing hub for advanced pharmaceutical development while supporting flexible end-to-end solutions for complex medicines and helping pharmaceutical partners accelerate their pipelines. The expansion marks a significant milestone in Serán's mission to provide fully integrated support starting with drug discovery and pre-clinical services, to first-in-human (FiH) trials, and ultimately to commercial-scale production of small-molecule therapeutics. Adjacent to the manufacturing facility, Serán last fall completed two new warehouse and light manufacturing buildings totaling 50,000 square feet. These spaces support critical materials handling, packaging, labeling and logistics functions, helping ensure efficient scale-up and dependable supply chain execution. "Our clients are bringing forward increasingly sophisticated pharmaceuticals which demands equally sophisticated development and manufacturing capabilities," said Dan Smithey, CEO of Serán BioScience. "Serán is a partner that can solve challenges early and then reliably carry those solutions through to commercial production, and this investment in our campus strengthens our ability to do exactly that. We appreciate the close collaboration with our development and construction partner, Mortenson, as we bring this next phase of Serán's growth to life." "Serán's project reflects the level of technical complexity and quality standards we see driving growth in life sciences manufacturing today," said Pat Clemons, project executive with Mortenson. "Our team is proud to support a facility that is purpose-built for advanced pharmaceutical production while contributing to the long-term economic strength of the Bend region." Located just minutes from Serán's existing 90,000-square-foot clinical development and manufacturing campus, the new commercial site will operate as a seamless extension of the company's established clinical operations and is expected to add as many as 150 employees as manufacturing expands. Serán's Bend-based workforce currently includes more than 190 highly skilled professionals across 10 specialized buildings, equipped with advanced technologies such as nano milling, micronization, dry and wet granulation, single and multi-layer tableting, aqueous and organic solvent coating, encapsulation, spray-dried dispersions, powder for inhalation and twin-screw melt extrusion. Together, these capabilities support oral solid dose programs from early formulation through commercial manufacturing, packaging and labeling. Founded in Bend in 2016, Serán is a leading contract development and manufacturing organization providing a comprehensive suite of development, analytical and clinical manufacturing services to pharmaceutical and biotechnology companies. Serán's deep experience and expertise in materials science, formulation development, particle and process engineering and pharmaceutical manufacturing enables optimum solutions for their customers' most difficult drug development challenges. "We're proud to support Serán's continued investment in Bend and its commitment to serving both emerging biotechnology companies and global pharmaceutical organizations," said Mike Clifford, Vice President and General Manager at Mortenson. "This is a significant life sciences project for Central Oregon. By delivering flexible, science-driven facilities, we're helping translate innovation into commercially viable therapies while contributing to the continued growth of the region's life sciences market." About Serán BioScience Serán BioScience partners with pharmaceutical and biotechnology companies to accelerate the development and production of complex, patient-centric medicines. The Bend facility reflects the company's long-term investment in innovation, workforce growth, and collaboration, enhancing Serán's ability to support the next generation of pharmaceutical solutions while strengthening the regional life sciences ecosystem. Mortenson is a U.S.-based, top-20 builder, developer, and engineering services provider serving the commercial, institutional, and energy sectors. Mortenson's expanding portfolio of integrated services helps its customers move their strategies forward, ensuring their investments result in high-performing assets. The result is a turnkey partner, fully invested in the business success of its customers. Founded in 1954, Mortenson has operations across the U.S. with offices in Chicago, Denver, Fargo, Iowa City, Milwaukee, Minneapolis, Nashville, Phoenix, Portland, Salt Lake City, San Antonio, Seattle, and Washington, D.C. For additional information, visit www.mortenson.com.