--- title: 'Manager, cGMP Training & Learning Programs at Serán BioScience' canonical: 'https://feeny.ai/job/manager-cgmp-training-learning-programs-seran-bioscience-bend-yq4zy81mnhtq' type: 'job' last_seen: '2026-10-23' --- # Manager, cGMP Training & Learning Programs 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/2924982e-ec1c-43aa-aa0f-fa64a2bd377c ## Job description The cGMP Training Program Manager is responsible for managing and continuously improving the organization's GxP Training Program to ensure personnel are trained, qualified, and capable of performing assigned responsibilities in compliance with applicable regulatory requirements and internal Quality Management System (QMS) procedures. This role oversees training governance, curriculum development, learning management systems, training compliance, employee qualification programs, training effectiveness assessments, and inspection readiness related to personnel competency. The position serves as the site Subject Matter Expert for GxP training requirements and partners with all functional departments to establish sustainable training programs that support clinical and commercial manufacturing operations. The cGMP Training Program Manager promotes a culture of quality, continuous learning, and regulatory compliance while ensuring training systems remain scalable to support organizational growth. Leader Responsibilities - Leads and develops a high-performing Training department - 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 Duties & Responsibilities - Own and maintain the corporate GxP Training Program. - Develop and maintain training policies, procedures, and governance practices. - Ensure training processes comply with applicable GxP regulations and industry requirements. - Establish systems supporting employee onboarding, qualification, retraining, and continuing education. - Monitor organizational training health and compliance. - Manage training coordinators and training administrators as applicable. - Provide guidance and support to departmental trainers and subject matter experts. - Develop training governance and site-wide training standards. - Support qualification of trainers and training owners. - Establish departmental objectives and performance metrics. - Lead continuous improvement initiatives within the training function. Learning Management System Administration - Maintain and optimize electronic Learning Management System (LMS) processes. - Ensure training assignments are current, accurate, and aligned to job responsibilities. - Oversee user access, curricula management, and training workflows. - Partner with Information Technology and system administrators on validation, upgrades, and enhancements. - Ensure data integrity and inspection readiness of training records. ## Role-Based Curriculum Development - Develop and maintain role-based training curricula for all cGMP functions. - Ensure curricula accurately reflect required competencies and job functions. - Collaborate with department leaders to define qualification requirements. - Periodically assess training requirements to ensure continued effectiveness and compliance. - Support creation of learning paths for new and existing employees. Employee Qualification Program - Develop and maintain personnel qualification programs. - Ensure qualification requirements are documented and consistently applied. - Establish qualification standards for critical GMP activities. - Coordinate qualification and requalification activities. - Monitor ongoing competency requirements. Training Effectiveness Program - Establish mechanisms to evaluate training effectiveness. - Develop tools to assess employee comprehension and competency. - Monitor trends related to human error and training-related deviations. - Collaborate with management to identify performance gaps and targeted learning opportunities. - Drive continual improvements to training methodologies. New Employee Onboarding - Manage GMP onboarding programs for new employees. - Ensure timely completion of required training prior to independent work. - Coordinate cross-functional participation in onboarding activities. - Standardize onboarding processes across departments. Inspection Readiness Support - Maintain training records in a state of continuous inspection readiness. - Support client audits, internal audits, and regulatory inspections. - Coordinate retrieval and presentation of training records during inspections. - Ensure training-related observations are addressed through effective remediation plans. Metrics and Compliance Monitoring - Partner closely with Quality Systems personnel to ensure appropriate training support for the QMS and ensure training impacts are appropriately assessed and implemented when quality systems change. - Develop and maintain training performance metrics and dashboards. - Provide routine reporting to leadership and Management Review. Quality Culture & Continuous Improvement - Promote a culture of ownership, accountability, and compliance. - Develop educational programs that strengthen quality culture across the organization. - Identify opportunities to improve learning effectiveness and employee engagement. - Support implementation of modern adult-learning principles and workforce development strategies. Required Skills & Abilities - Thorough understanding of FDA, EU, ICH, and cGMP training requirements. - Strong knowledge of Quality Management Systems. - Experience designing qualification and competency programs. - Demonstrated ability to collaborate and work in cross-functional teams. - Strong presentation and facilitation skills. - Exceptional organizational and project management skills. - Ability to influence personnel across all organizational levels. - Strong analytical and problem-solving capabilities. - Excellent written and verbal communication skills. - Proficiency with LMS platforms, Microsoft Office, and electronic quality systems. Education & Experience - Bachelor's degree in Life Sciences, Education, Organizational Development, Quality, Engineering, or related discipline required. - Minimum of 5-8 years of experience in pharmaceutical, biotechnology, medical device, or CDMO environments. - Minimum of 3 years managing GxP training programs or quality systems. - Experience supporting client audits and regulatory inspections. - Experience administering electronic learning management systems. - Demonstrated understanding of cGMP regulations and personnel qualification requirements. 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. 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