Reporting to the Site Learning and Development Lead, the Senior Site Learning Specialist will define, develop, and facilitate all learning and development plans and activities for the Durham HPV Bulk facility within the site in support of the site’s learning strategy and Annual Learning Plan. This individual be the primary learning & development point of contact for the Durham HPV Bulk Facility and will partner with the manufacturing systems design and commercialization team to develop and lead the learning and development strategy for the on-boarding and training of the staff for the new facility. The successful onboarding and training of the personnel for the new facility is critical to achieving Right-the-First-Time execution of PPQ and a vertical start-up to full production capacity.
The candidate should have experience in the areas of learning, talent, HR or comparable areas and have worked within a Biopharmaceutical and/or Pharmaceutical Manufacturing environment with knowledge of Quality Management systems, cGMP, and regulatory inspections.
The candidate should possess the change management skills necessary to demonstrate support for innovation and for organizational changes needed to improve the organization’s effectiveness; initiating, sponsoring, and implementing organizational change; helping others to successfully manage organizational change.
Collaborate with the Durham HPV bulk training lead and stakeholders to define desired performance outcomes; provide feedback and coaching on issues related to learning programs and policies.
Development and execution of the learning strategy for the Durham HPV bulk facility and enable one integrated strategy and plan.
Demonstrate an understanding of processes and methodology to execute appropriate learning solutions.
Conduct learning needs assessments and identify performance needs and gaps and facilitate delivery of learning solutions, when appropriate; document needs for customization or localization of global core/common learning programs; develops solutions, as needed.
Qualify and coach skills trainers and classroom facilitators within client group to ensure optimal delivery of training programs.
Monitor, analyze, interpret and report internal trends; make recommendations for learning solutions, as appropriate.
Act as liaison between Learning Shared Services (LSS) and stakeholders to ensure alignment with learning needs. Ensure smooth client interactions during learning design engagements by facilitating communication across all involved stakeholders and teams.
Support the identification of alternate non-training solutions when appropriate including collaborative use of LSS for appropriate tasks in learning administration management.
Ensures client is in Permanent Inspection Readiness and cGMP Compliance as it relates to Training/Learning & Development.
Support any EHS or Quality Compliance regulatory audits as required
Solicit feedback on the overall success of the provided learning solutions. Interpret and discuss feedback with stakeholders. Communicate recommendations based on data analysis, supported by LSS and COE. Activate improvements to further enhance learning program effectiveness and sustainability.
Shared responsibility for the execution of Division, Subdivision, and Role-based curricula for local site content in conjunction with the Divisional Learning and Development team.
Ensure delivery and execution of globally developed, locally managed Core & Common curriculum and on- boarding curriculum, which incorporates core/common Divisional Onboarding Program.
Develops and curates local content in partnership with Global L&D, leveraging LSS resources.
Education Minimum Requirement
Required Experience and Skills
Minimum of five (5) years of experience in a people development role (L&D/HR/OD) or demonstrated ability to proactively develop employees
Minimum of five (5) years of pharmaceutical manufacturing experience
Working knowledge and application of Adult Learning Principles and Evaluation Methodologies
Quality Management systems, cGMP, and regulatory inspections
Preferred Experience and Skills
Experience in Lean Manufacturing Production Systems
Knowledge of Manufacturing End E Business Process & Functions
Working Across Boundaries: Thinks and acts broadly, beyond one’s silo – bridges boundaries across teams, functions, divisions, geographies, external stakeholders and customers. Demonstrates an understanding of how one’s job responsibilities contribute to the department’s goals and a knowledge of the business’s core strategy for long-term success.
Fosters Interpersonal Relationships & Collaboration: Actively listens and seeks to understand differing perspectives; work together to achieve the common goals of the company. Demonstrated skill in applying approaches, tools, and techniques for working with individuals and groups in a constructive and collaborative manner, including the ability to build and maintain critical networks and collaborative relationships.
Productive Communications (Oral & Written): Ability to distribute accurate information and craft messages for appropriate target audiences, with guidance if needed. Speaks and writes clearly and concisely with the ability to select the appropriate form of communication to share information.
Drives Results: Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results.
Learning System Operations: Demonstrates a basic understanding of established learning technologies, tools, and systems with an understanding of the role of learning technology in employee capability development. Demonstrates awareness of data standards and system maintenance structure.
Adult Learning Theory and Practice: Familiarity with the concepts and practices of adult learning and its application to the workplace.
Learning Consultation: Leads, develops and communicates learning strategies for learning plan of action. Nurtures client relationship to enable a trusted partnership and leads needs assessment and gap analysis to pinpoint areas of opportunity for multiple and/or long-term learning solutions and advises on appropriateness of learning solutions. Develops case for solution to address business needs, leveraging learning solutions, Change Execution Methodology, Inclusion and Lean Production Systems. Articulates impact and benefits of learning organization on business success to stakeholders
Agile Learning Design & Execution: Use elements like experimentation to arrive at innovative solutions and strategies needed to holistically develop worker capability and workplace and work conditions to achieve business goals. Includes execution of learning technologies and interventions; agile, scrum, and continuous learning methodologies; facilitation; conducting train the trainers; and skills qualification. Leverage internal and external assets and facilitate information, knowledge, and expertise sharing relevant to a particular topic or area of interest to achieve business outcomes.
Digital Acumen: Develop digital workplaces and digital work forces, deploy technology that changes how people work, relate to each other, and learn using a wide variety of tools to build a digital organization, workforce, and workplace based on awareness of emerging technologies. Collaborate with IT and the business to integrate learning into the digital and automation strategies.
Learning Analytics: With an understanding of the talent factors that drive performance, monitor business KPIs, talent metrics, and performance metrics and tell a story with data to influence and help the business make better strategic and tactical decisions and appreciate how learning initiatives are impacting business performance. Provide employees with data to help them continue to improve.
Learning Measurement & Evaluation: Ability to gather, analyze and report information regarding the impact of learning solutions against key business drivers and evolving strategic priorities. Ability to present information in a way that is meaningful to the organization, and to use learning metrics and analytics to inform organizational decision making.
Modern Learning Champion: Act as an advocate for L&D by messaging vision of the company’s learning culture by building people capabilities through relevant continuous learning experiences. Specifically focused on- Personalized Adaptive Learning, Modernizing the Learner experience, and integrating learning in the flow of work.
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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