CMC & Manufacturing, Science and Technology Drug Substance Lead

GeneralGeneralFull TimeRemoteSeniorTeam 1,001-5,000Since 1991H1B No SponsorCompany SiteLinkedIn

Location

North Carolina

Posted

2 hours ago

Salary

$153K - $211K / year

Seniority

Senior

Bachelor Degree10 yrs expEnglish

Job Description

CMC & Manufacturing, Science and Technology Drug Substance Lead

Sobi - Swedish Orphan Biovitrum AB (publ)

• Responsible for Drug Substance (DS) synthesis of a small molecule used in oral dosage forms. • Lead the technical workstreams of manufacturing process transfers from development to commercial site and between commercial sites. • Scale-up activities, process validations and oversee manufacturing of Drug Substance small molecules at external manufacturers for projects in clinical and commercial phase. • Collaborate effectively with external manufacturing partners to oversee all technical drug substance synthesis aspects (GMP and non-GMP steps). • Lead internal activities related to external manufacturing such as process change assessments, major/critical deviations, risk assessments and CAPAs. • Review and supervise design, set up, execution and documentation of DS related technical studies (CMC development as well as commercial operations), process and equipment qualifications and validations. • Write and review applicable sections in registration files, variations and market expansion.

Job Requirements

  • University education in Chemistry, Pharmacy or similar.
  • 10+ years of experience of development and manufacturing of Drug Substance small molecule, non-sterile dosage forms for clinical and commercial use.
  • Recognized expert in synthetic organic chemistry and process R&D; experience with deuterated molecules is a plus.
  • Experience of working with external manufacturers.
  • Demonstrable experience of working in cross functional team with ability to lead functional teams, prioritize and be an effective decision maker.
  • Experience of regulatory guidelines (FDA & EMA), regulatory authorities communication and filing documentation.
  • Fluent in English, intermediate to full proficiency in Chinese is a plus.

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

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