Sobi group
Senior Process Manager MSAT
Sobi group, Durham, North Carolina, United States, 27703
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 workEmphasis on work/life balanceCollaborative and team-oriented environmentOpportunities for professional growthDiversity and InclusionMaking a positive impact to help ultra-rare disease patients who are in need of life-saving treatmentsJob 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 Sobi's clinical and commercial manufacturing processes from internal and external networks. MSAT ensures compliant, reliable, cost-effective, and sustainable manufacturing of our products now and in the future. The MSAT team holds the senior scientific and technical knowledge for the manufacturing of Sobi's clinical and commercial products and is responsible for always keeping the internal and external manufacturing processes in a validated stage.Key ResponsibilitiesProcess 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 SOPs 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 oversee manufacturing of DP processes at external manufacturers for Sobi projects in clinical and commercial phases.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 ExperienceUniversity education in Chemistry, Biology, Biotechnology, Pharmacy, or similar.5+ years of experience in development and manufacturing of DP for clinical and commercial use.Skills/Knowledge/LanguagesScientific and technical background of CMC development and manufacturing of aseptic drug products.Recognized expert in aseptic drug product manufacturing.Demonstrable experience of working in cross-functional teams with the ability to multitask, prioritize, and be an effective decision-maker.Experience of regulatory guidelines, regulatory authorities communication, and file documentation.Personal AttributesFulfillment of all of Sobi's 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 diseases.
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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 Sobi's clinical and commercial manufacturing processes from internal and external networks. MSAT ensures compliant, reliable, cost-effective, and sustainable manufacturing of our products now and in the future. The MSAT team holds the senior scientific and technical knowledge for the manufacturing of Sobi's clinical and commercial products and is responsible for always keeping the internal and external manufacturing processes in a validated stage.Key ResponsibilitiesProcess 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 SOPs 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 oversee manufacturing of DP processes at external manufacturers for Sobi projects in clinical and commercial phases.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 ExperienceUniversity education in Chemistry, Biology, Biotechnology, Pharmacy, or similar.5+ years of experience in development and manufacturing of DP for clinical and commercial use.Skills/Knowledge/LanguagesScientific and technical background of CMC development and manufacturing of aseptic drug products.Recognized expert in aseptic drug product manufacturing.Demonstrable experience of working in cross-functional teams with the ability to multitask, prioritize, and be an effective decision-maker.Experience of regulatory guidelines, regulatory authorities communication, and file documentation.Personal AttributesFulfillment of all of Sobi's 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 diseases.
#J-18808-Ljbffr