MSAT Technical Lead – Drug Substance (Sr Manager)

Location Requirement:
This position may be based near RaleighNC or Boston MA. The role requires periodic travel between both locations to support crosssite collaboration and business needs.

Science and Technology (SAT) is part of the Global CMC Science & Technology Department (GCSAT). GCSAT is responsible for the optimization and life-cycle management of Sobis clinical and commercial manufacturing and analytical processes across internal and external networks. SAT ensures compliant reliable cost-effective and sustainable manufacturing and testing of our products now and in the future. The SAT team holds the senior scientific and technical knowledge for the manufacturing and analytical testing of Sobis clinical and commercial products and is responsible for maintaining the internal and external manufacturing/analytical processes at a validated stage.

Responsibilities:

• Subject matter expert (SME) for Small Molecules Drug Substance Manufacturing. 
• Process owner of Small Molecules process validation for Sobi products. 
• Lead and execute MSAT projects such as manufacturing process and cost improvement as part of LCM. 
• Participate in internal activities related to (external) manufacturing such as process changes major/critical deviations risk assessments and CAPAs. 
• Issue review and approve applicable internal and external SOPs and manufacturing instructions. 
• Review and supervise the setup execution and documentation of technical studies qualifications and validations. 
• Write and review applicable sections of the APR/PQR. 
• Write and review applicable sections in registration files variations and market expansion. 
• Support in sourcing evaluation of new Small Molecules contract manufacturers and participation in developing supply and quality agreements. 
• Lead the technical part of a product transfer scale-up activities validations and oversee manufacturing of Small Molecules processes at external manufacturers for Sobi projects in the clinical and commercial phase. 
• Be aware of external biopharmaceutical manufacturing technology advancements understand and introduce new technologies and how they may be applicable to process innovation cost or yield improvement 

Qualifications :

Requirements:

• University degree in Chemistry Biology Biotechnology Pharmacy or similar
• 6 years of experience in the development and manufacturing of small-molecule drug substances for clinical and commercial use
• 3 years of experience in a commercial setting leading the technical pieces of product transfer scale-up and validation
• Experience reviewing applicable sections of the APR/PQR
• Scientific and technical background in CMC development and manufacturing of drug substances small molecules
• Experience with regulatory guidelines regulatory authorities communication and file documentation 
• Experience overseeing external vendors such as CMOs CDMOs etc.
• Demonstrable experience working in a cross-functional team with the ability to multitask prioritize and be an effective decision-maker

Personal Attributes 

• Fulfillment of all of Sobis values  
• Ability to act independently and take initiative 
• Good communication skills oral/written and listening  
• Strong team player 

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 $140000 - $165000.  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 Sobis 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 1900 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 were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre 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 cant 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   

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Remote Work :

Yes

Employment Type :

Full-time