External Manufacturing Senior Manager (DS/DP)

Sobi•Raleigh, NC

6h•$130,000 - $165,000

About The Position

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.

Requirements

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
Excellent verbal and written communication skills in English and ability to communicate in a business environment
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

Nice To Haves

Excellent verbal and written communication skills in Swedish

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 FG and IMP processes at 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

Benefits

Competitive compensation for your work
Generous time off policy
Opportunity to broaden your horizons by attending popular conferences
Emphasis on work/life balance
Collaborative and team-oriented environment
Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
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.