Position Overview:
The SPM Group Lead will be responsible for managing a team of six Site Product Managers within the Aubonne MSAT team. This role will involve overseeing project execution, particularly in the area of new commercial product introductions to the site as well as CMC lifecycle projects, ensuring compliance with regulatory standards, and driving continuous improvement initiatives within the team. The Group Lead will play a crucial role in the MSAT leadership team, collaborating closely with various internal and external stakeholders to achieve project goals.
Key Responsibilities:
* Lead and mentor a team of six Site Product Managers, providing guidance and support in project management practices and methodologies.
* Oversee the planning, execution, and delivery of complex projects related to new product introductions, Technology Transfers (TT), CMC lifecycle projects and process validations for commercial products.
* Specifically manage the introduction of new commercial products to the site, ensuring alignment with production capabilities and regulatory requirements.
* Ensure alignment with the Aubonne MSAT Director on project priorities, timelines, and resource allocation.
* Foster a collaborative environment within the team and across departments, facilitating effective communication and teamwork.
* Establish and maintain strong relationships with internal stakeholders, including Production, Quality Assurance, Regulatory Compliance, and external partners such as CMC teams, TT teams and wider GBM and GCD networks.
* Monitor project progress and performance, identifying risks and implementing mitigation strategies to ensure timely delivery.
* Define and provide the strategic product portfolio view to the site and to external partners.
* Orchestrate cross-department product management for the site, including where required cross-site collaboration.
* Contribute to the development of project strategies and ensure adherence to Good Manufacturing Practices (GMP) and regulatory requirements.
* Prepare and present project updates to senior management and stakeholders, ensuring transparency and accountability.
* Drive continuous improvement initiatives within the SPM team, promoting best practices and innovative solutions.
* Develop the SPMs into true product managers for the site where they coordinate and manage product-related topics/projects on the site.
* Develop the SPMs to be the single point of contact for the product for MSAT and additionally the single point of contact for the product for the site for requests related to the product coming from external groups like GRA CMC, CMC, GMSAT TT, etc.
Qualifications:
* Bachelor degree in Biotechnology, Process Engineering, Pharmacy, or a related field; advanced degree preferred.
* Minimum of 8 years of experience in project management within a biopharmaceutical or manufacturing environment, with a strong emphasis on technology transfer, process validation, and new product introductions.
* Proven track record of leading cross-functional teams and managing complex projects successfully.
* Strong knowledge of GMP regulations and experience with regulatory submissions.
* Excellent leadership, communication, and interpersonal skills, with the ability to influence and motivate others.
* Proficiency in project management tools and methodologies; certification (e.g., PMP) is a plus.
* Fluent in English; proficiency in French is an advantage.
* Experienced in managing a small team of varying experience.
Personal Attributes:
* Purposeful and results-driven, with a focus on achieving project goals.
* Strong leader with broad shoulders to manage cross-functional product management with good emotional intelligence, technical know-how, and stakeholder management.
* Innovative thinker, capable of developing creative solutions to challenges.
* Collaborative and empowering, fostering a positive team culture.
Join us at Merck BioPharma Aubonne and play a crucial role in advancing our mission to deliver high-quality biologics to the market. If you are ready to take on this exciting challenge, we invite you to apply
Department: MSAT (Manufacturing Science and Technology)
Reporting To: Aubonne MSAT Director
Job evaluation: Manager 3