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Sobi - Swedish Orphan Biovitrum AB

Headquartered in Stockholm, Sweden, Swedish Orphan Biovitrum AB is an international biopharmaceutical company dedicated to transforming the lives of individuals

MSAT Technical Lead – Drug Substance

Location

North Carolina

Posted

50 days ago

Salary

$153K - $211K / year

Seniority

Senior

Bachelor Degree10 yrs expEnglish

Job Description

MSAT Technical Lead – Drug Substance

Sobi - Swedish Orphan Biovitrum AB

• 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 SOP’s 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

Job Requirements

  • University degree in Chemistry, Biology, Biotechnology, Pharmacy, or similar
  • +10 years of experience in the development and manufacturing of small-molecule drug substances for clinical and commercial use
  • Scientific and technical background in CMC development and manufacturing of Drug Substance, Small Molecules
  • Significant NDA experience, preferably as a lead
  • Experience with regulatory guidelines, regulatory authorities communication, and file documentation
  • Experience overseeing external vendors such as CMOs, CDMOs, etc.
  • Demonstrable experience of working in a cross-functional team with the ability to multitask, prioritize, and be an effective decision maker
  • Fluent in English
  • Mandarin proficiency is helpful

Benefits

  • 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

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