Celltrion is a leading biopharmaceutical company that specializes in research, development and manufacturing of innovative therapeutics. We are committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. We have been at the forefront of biotherapeutic development uncovering new ways of targeting the drivers of disease by creating next-generation biologics and small molecule products.

Celltrion Branchburg, LLC is a subsidiary of Celltrion USA, established in 2025 following Celltrion USA’s acquisition of Eli Lilly’s drug substance (DS) manufacturing facility located in Branchburg. By linking robust local manufacturing capabilities with an existing direct sales network, we aim to generate greater synergies across our operations. Looking ahead, we also anticipate expanding into the global contract manufacturing organization (CMO) sector.

Position Brand Description:

This position is responsible to establish and maintain the Learning and Development (L&D) Business Partnership and Operational Excellence (BPOE) for learning systems, documentation, and processes across the Celltrion Branchburg NJ site. The L&D BPOE is responsible to ensure strong L&D business partnerships and maintain operational excellence and training compliance across the Celltrion Branchburg site. This role leads the design, coordination, and implementation of learning solutions that support the Celltrion Branchburg functional areas. In addition, the L&D BPOE drives capability development by addressing competency gaps, ensuring personnel qualification, and supporting regulatory compliance. The L&D BPOE plays a critical role in enabling business performance by delivering effective, innovative, and compliant learning programs aligned with organizational goals. L&D BPOE roles work in a team setting where key responsibilities and deliverables are aligned with each team member to ensure learning and development excellence.

Key Responsibilities/Deliverables

L&D Business Partnership & Program Delivery:

1. Partner with Celltrion Branchburg business leaders to identify learning needs and deliver targeted training solutions.
2. Design, coordinate, and implement learning programs to close capability and competency gaps.
3. Manage end-to-end training projects, including program quality, audience identification, and instructor selection.
4. Monitor progress, measure outcomes, and implement feedback loops to continuously improve learning effectiveness.
5. Anticipate risks, address roadblocks, and coordinate with internal and external learning service providers.

Multi-Product Execution & Business Agility:

1. Support multi-type production and future U.S. expansion initiatives through active L&D partnership.
2. Participate in cross-functional meetings (e.g., Flow, Process) to align priorities and ensure effective communication.
3. Integrate Voice of Customer (VOC), change control, and project management into learning solutions.

Training Innovation & Learning Experience Design:

1. Drive innovation by transitioning from “read and understand” approaches to immersive, value-added training experiences.
2. Optimize learning plans to reduce time to qualification and improve training efficiency.
3. Lead initiatives to achieve zero overdue training across the site.

Qualification Programs & Risk-Based Training:

1. Own or partner on site-wide qualification programs (e.g., Trainer Qualification, Lead Investigator, Operations, Safety).
2. Serve as the primary L&D contact for course, curriculum, and program owners.
3. Apply risk-based training design principles to qualification, requalification, CAPA, and remediation training.

Training Compliance & Operational Excellence:

1. Ensure training compliance and maintain audit readiness in alignment with FDA and regulatory requirements.
2. Oversee administration of dual Learning Management Systems (LMS): 
   1. GMP Training (SuccessFactors LMS)
   2. Non-GMP Training (ADP LMS)
3. Own training metrics, reporting, and monitoring processes.
4. Serve as a technical partner for global sites (e.g., Songo, KR).

Training Matrix & Content Governance:

1. Provide SME oversight for Training Matrix design and management.
2. Conduct risk-based reviews of training-related documents, including procedures, task qualification checklists, and qualification records.
3. Partner with vendors to develop high-quality learning content, including exams and DELTA training.

Systems, Processes & Continuous Improvement:

1. Lead curriculum and training item periodic reviews.
2. Optimize use of LMS capabilities and promote best practices.
3. Serve as SME for L&D processes, procedures, and documentation.
4. Partner with external service providers (e.g., Conduent) and manage learning request workflows and metrics.

Employee Lifecycle & Training Management:

1. Ensure seamless learning support across the employee lifecycle, including onboarding, New Employee Orientation (NEO), and qualification.
2. Oversee training matrices, job descriptions, and personnel qualification processes.
3. Manage training assignments and alignment for employee transfers, leaves, and returns.
4. Provide support for scheduled training offerings and instructor coordination. 

Manage Relationships with Key Stakeholders and Customers:

1. The L&D BPOE will interact routinely with business area leaders, course and curricula owners, qualified instructors, and external contractors.

Basic Requirements

1. Bachelor’s degree in a relevant field (e.g., Life Sciences, Education, Organizational Development) required.
2. Minimum of 1 year of experience in Learning & Development or other related field, preferably in a regulated environment (pharmaceutical, biotech, or manufacturing).

Desired Key Skills & Competencies

1. Strong knowledge of GMP training requirements and regulatory compliance (FDA, audit readiness).
2. Expertise in learning program design, instructional design, and adult learning principles.
3. Experience managing LMS platforms (e.g., SuccessFactors, ADP).
4. Demonstrated ability to apply risk-based approaches to training and qualification.
5. Strong project management, stakeholder engagement, and communication skills.
6. Ability to drive innovation and continuous improvement in learning strategies.
7. Data-driven mindset with experience using metrics to measure and improve performance.

Additional Information

1. This role reports to the Branchburg L&D Leader.
2. Requires close collaboration with cross-functional teams, global partners, and external vendors.
3. Plays a key role in supporting site growth, operational excellence, and workforce capability development.

This role is exempt and the anticipated compensation for this role is $64,500 - $104,000.

This is a banded role, and candidates will be placed within the range based on experience, skills, internal equity, and market considerations.

Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave), medical, dental, and vision insurance, life insurance, a company-matched retirement savings plan, wellness programs, and short- and long-term disability benefits. Hybrid work flexibility may be available based on business needs; relocation assistance is not provided. 

Celltrion Branchburg, LLC is proud to be Equal Opportunity Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status.