External Manufacturing Senior Manager (DS/DP)

Responsibilities

• Team leader cross functional Virtual Plant Team (DS/DP) as applicable
• Strategic and operational CMO management
• Strategic Partner Management
• SME in own field
• Process owner
• Responsible and main contact person for CMOs, leading Business Review and Operational Meetings
• Supplier relationship management for CMO(s), 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
• Lead or participate in internal activities related to external manufacturing such as change management, major/critical deviations and CAPAs
• Responsible for maintaining and improving Primary (for Tabs & Caps) and Secondary packaging processes at CMos
• Participate in tech transfer validation and manufacturing of DS/DP external manufacturers for Sobi projects in clinical and commercial phase
• Issue, review and/or approve applicable external and internal SOP's and manufacturing instructions
• Review applicable sections of the APR/PQR
• Budget input and adherence for CMO/CLO related costs
• Lead or participate in projects incl deviations investigations and CAPAs
• Driving continuous improvements to maintain efficient ways of working internally and at external network
• University degree within Manufacturing, Supply Chain or equivalent or other relevant scientific fields, or equivalent work experience
• 10 years of experience in the pharmaceutical industry
• Demonstrated experience of working in a cross functional matrixed environment and evidence of successful collaboration with internal and external parties
• Min 5 years' experience from coordinating roles, including Project Management
• Good knowledge of cGMP manufacturing of biologics and/or small molecule pharmaceuticals, including investigating deviations and change management.
• Previous work experience involving direct contact with CMO, CRO´s or other external parties
• Good knowledge of Office and hands on experience of digital systems
• 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
• Driven, flexible with strong team working skills
• Analytical and problem-solving mindset.
• Strong ability to work independently and to make priorities 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.
• Negotiation skills
• Compensation and Total Rewards at Sobi
• At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards.
• Your total compensation at Sobi goes beyond just your base salary and annual bonus. It also includes a robust suite of benefits, such as:
• A competitive 401(k) match to support your financial future.
• Tuition and wellness reimbursements to invest in your personal and professional growth.
• A comprehensive medical, dental, and vision package to prioritize your health and well-being.
• Additional recognition awards to celebrate your achievements.
• The base salary range for this role is $130,000-$165,000 . Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details.
• All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.
• Why Join Us?

Benefits

Additional Information

External DS/DP Manufacturing 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.

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