Job Description
External Packaging & Clinical Supplies is part of External Manufacturing Operations & SRM. External Manufacturing Operations & SRM is responsible for operational oversight of clinical and commercial- external manufacturing of Drug Substance, Drug Product and Finished Goods (Including IMP Supply) for Sobi projects and products world-wide. The responsibility includes providing leadership and operational excellence of compliant manufacturing and overseeing the management and delivery from external CMOs and CLOs, that can meet global health authority requirements and Sobi needs today and in the future.
Key Responsibilities/Scope of the Job
* Management of the External Packaging & Clinical Supplies team including direct reports responsibility
* Lead employees within the External Packaging & Clinical Supplies team including PMP, salary review and talent development
* Supplier relationship management and process development including developing digital CMO management
* Budget responsibility and follow up
* Drive innovation including digital transformation and applications, to maintain and develop efficient ways of working internally and at external network
* Acting as needed as CMO manager for Packaging CMO, Clinical supplies and other operative tasks within the area of responsibility
* Strategic and operational CMO management, ensuring e.g. supply agreements, change orders, improvements and OTIF delivery
* Participate in Sourcing evaluation of new contract manufacturers and developing supply and quality agreements
* Issue, review and/or approve applicable external and internal SOP’s and manufacturing instructions
Qualifications
Education/Learning Experience/Work Experience
Required:
* University degree or business degree with appropriate SRM experience or equivalent
* At least 5 years of experience in the pharmaceutical/biotech industry
* Line Manager experience
* Demonstrated experience of successful management of external suppliers and manufacturers including negotiation experience
* Demonstrated success in managing product SPC/COGS and continuous improvements
* Experience and knowledge of cGMP FG manufacturing and industry regulatory standards
* Demonstrated experience of working in a cross functional matrixed environment and evidence of successful collaboration with internal and external parties
Desired: Clinical Supplies management experience
Skills/Knowledge/Languages
Required: Excellent verbal and written communication skills in English and ability to communicate in a business environment
Desired: Excellent verbal and written communication skills in Swedish
Personal Attributes
Required:
* Strong leadership, collaboration and communication skills
* Good business operational, analytical and strategic planning skills.
* Business drive and negotiation skills.
* A team player with a problem solving mindset.
* Ability to influence, motivate and collaborate cross-functionally.
* Strong ability to work independently and to make priorities in order to deliver business critical items in time.
* Demonstrate the Sobi Values; Care for our patients, for our colleagues and for our company, Ambition, Urgency, Ownership and Partnership.