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Senior Process Manager MSAT

4 months ago

Durham, United States Sobi Full time
Job DescriptionJob DescriptionCompany 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

Manufacturing Science and Technology  (MSAT) is part of the Global CMC, Science & Technology Department (GCSAT).

GCSAT is responsible for optimization and life cycle management of Sobis clinical and commercial manufacturing processes from internal and external network. MSAT ensures compliant, reliable, cost effective and sustainable manufacturing of our products now and in future. The MSAT team holds the senior scientific and technical knowledge for the manufacturing of Sobis clinical and commercial products and is responsible for always keeping the internal and external manufacturing processes in a validated stage.

Key Responsibilities

 

  • Subject matter expert (SME) for DP.
  • Process owner of DP 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 SOP’s and manufacturing instructions.
  • Review and supervise set up, execution and documentation of technical studies, qualifications and validations.
  • Contribute during set up of new product specifications and stability programs and review changes thereof.
  • 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 DP contract manufacturers and participation in developing supply and quality agreements.
  • Lead the technical part of a product transfer, scale up activities, validations and oversees manufacturing of DP processes at external manufacturers for Sobi projects in 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

Education/Learning Experience/Work Experience

  • University education in Chemistry, Biology, Biotechnoclogy, Pharmacy or similar.
  • +5 years of experience of development and manufacturing of DP for clinical and commercial use.

 

Skills/Knowledge/Languages

  • Scientific and technical background of CMC development and manufacturing of aseptic DrugProduct.
  • Recognized expert in aspetic drug product manufacturing
  • Demonstrable experience of working in cross functional team with ability to multi task, prioritize and be an effective decision maker
  • Experience of regulatory guidelines, regulatory authorities communication and file documentation
  • Fluent in English

 

Personal Attributes

  • Fullfillment of all of Sobi CARE values
  • Ability to act independently and take initiative
  • Good communication skills, oral/written and listening
  • Strong team player

 



Additional Information

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 1,700 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.