External Manufacturing Manager

Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:

• Competitive compensation for your work
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Opportunities for professional growth
• Diversity and Inclusion
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Job Description

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.

This is an individual contributor position based in the US (NC).

Key Responsibitilies

• Team leader cross functional Virtual Plant Team (DS, DP, CLO as applicable)
• Strategic and operational CMO management:
• Responsible and main contact person for CMOs, leading Business Review and Operational Meetings or provide CMO Management input to partner BRM/JMSC.
• 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
• Participate in tech transfer, scale up, validation and manufacturing of DS and DP processes at external manufacturers for Sobi projects in clinical and commercial phase
• Issue, review and/or approve applicable external and internal SOP’s
• Review applicable sections of the APR/PQR
• Budget input and adherence for CMO/CLO related costs
• Lead or participate in projects
• Driving continuous improvements in order to maintain efficient ways of working internally and at external network.

Qualifications

Education/Learning Experience/Work Experience

Required: 

• University degree in Biotechnology or other relevant scientific fields, or equivalent work experience
• 5 years of experience in the pharmaceutical industry coupled to drug substance (both up and downstream processing) and/or drug product manufacturing
• Min 2 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´s/CLO’s or other external parties
• Good knowledge of Office and hands on experience of digital systems
• Ability to work in a cross functional matrixed environment and to successfully collaborate with internal and external parties

Skills/Knowledge/Languages

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

Personal Attributes

Required: 

• Driven, flexible, collaborative, and have strong team working skills
• Analytical and have a problem solving mindset.
• 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.

Desired:

• Negotiation skills

The base salary pay range for this role is $104,000-$142,000 annually. Actual pay for this position will take into account factors such as experience and location. In addition to a base salary, this position is also eligible for a compet