Arbetsbeskrivning

Atley Solutions is a global leader in commercial products and services for the development and manufacturing of radiopharmaceuticals based on Astatine-211. These pharmaceuticals are used in targeted alpha therapy, a promising treatment modality for metastatic cancer.

Our flagship product, the Atley C100 module, enables reliable and scalable manufacturing of At-211 based radiopharmaceuticals. The Atley C100 is in early commercial deployment and was launched in 2024 with multiple units now in use at academic and industrial facilities around the world. A critical part of Atley’s business model is the sale of single-use consumables for use with the Atley C100. These are both research and clinical-grade consumable kits, and can be both standardized products or drug-specific products developed on behalf of specific customers. 

We are expanding this area into a dedicated business line and are seeking a Consumables Project Manager to drive this effort into full-scale clinical and commercial deployment.

This role comprises project management for all consumables within Atley and bridges technical product development, quality/regulatory operations, and commercial execution.

You will take ownership of Atley’s consumables portfolio, guiding its evolution from research-grade to fully GMP compliant clinical kits.

The successful candidate will:

• Lead Atley’s transition from research-grade to clinical-grade consumables for purification and synthesis workflows on the Atley C100.
• Drive development of customer-specific synthesis consumables, ensuring seamless integration with the Atley C100 module.
• Manage subcontractors and regulatory partners in developing, validating, and producing GMP compliant consumables kits.
• Collaborate with regulatory consultants to ensure design, manufacturing, and release processes comply with applicable standards.
• Support commercial and customer-facing engagements for consumables development projects and sales.
• Establish internal know-how in clinical-grade consumables development and regulatory manufacturing.
• Contribute to defining Atley’s consumables strategy, ensuring scalability across multiple customer programs.

You will interface with internal teams (product development and business development) and external stakeholders (CMOs, regulatory consultants, and pharmaceutical clients) to manage the full product lifecycle, from concept to market delivery.

• Significant experience from product development, process engineering, or technical sales within pharmaceutical, medical device, or radiopharmaceutical sectors.
• Proven experience with clinical-grade consumables, single-use kits, or manufacturing components for GMP environments.
• Strong understanding of GMP, ISO 9001 or other relevant quality standards, validation, and quality documentation.
• Experience collaborating with CMOs, CROs, and regulatory consultants.
• Commercial experience in B2B technical sales, product management, or customer-specific product development.

• Strong project management and cross-functional coordination skills.
• Excellent communication skills, ability to engage technical and commercial stakeholders with equal credibility.
• Familiarity with product development documentation (URS, CoA, validation).
• Proactive, structured, and comfortable operating in a start-up environment with high autonomy.

Atley Solutions offers a supportive, forward-thinking environment where every team member plays a vital role in shaping the future of radiopharmaceutical manufacturing and hence the future of cancer treatment. This role provides the opportunity to:

• Join a fast-growing, science-driven company on a mission to enable development and commercialization of a new generation of therapies posed to change the lives of patients globally.
• Build a new business vertical central to Atley’s commercial strategy. Work closely with industry-leading partners and pharma clients in a highly collaborative and dynamic team.

To apply, please submit your resume and cover letter detailing your qualifications and interest in the Consumables Project Manager position. We look forward to hearing from you!

Location: This position can be offered at our HQ in Gothenburg, Sweden or our R&D and Product Development facility in Kristinehamn, Sweden. We are also open to remote/hybrid setups. Reports to: CTO Employment Type: Full-time, permanent