External Manufacturing Senior Manager (DS/DP) at Sobi

Raleigh, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

18 Jun, 26

Salary

165000.0

Posted On

20 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

CMO Management, Supplier Relationship Management, cGMP Manufacturing, Biologics, Small Molecule Pharmaceuticals, Change Management, Deviation Investigations, CAPAs, Tech Transfer, SOP Approval, Budget Input, Continuous Improvements, Cross Functional Team Leadership, Strategic Partner Management, Negotiation, Problem Solving

Industry

Pharmaceutical Manufacturing

Description

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. Our mission and culture at Sobi North America 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 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 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. Key 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 Qualifications 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 Additional Information 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? We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. An Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to [email protected] Know Your Rights Sobi Location: United States

Responsibilities

This role involves leading cross-functional Virtual Plant Teams and providing strategic and operational management for Contract Manufacturing Organizations (CMOs) and Contract Logistics Organizations (CLOs) globally. Key duties include serving as the main contact person for CMOs, managing supplier relationships, overseeing supply agreements, and participating in technical transfer and validation activities for clinical and commercial projects.