Senior Process Manager MSAT

vor 4 Wochen

Basel, Schweiz Sobi group Vollzeit

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

The right candidate will manage the following tasks:

  • Subject matter expert (SME) for Drug Substance of small molecule, non-sterile dosage forms.
  • Process owner of Drug Substance small molecule, non-sterile dosage forms validation for Sobi products.
  • 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 analytical 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.
  • Lead and execute MSAT projects such as manufacturing process and cost improvement as part of LCM.
  • Support in sourcing evaluation of new Drug Substance small molecule, non-sterile dosage form 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 Drug Substance small molecule, non-sterile dosage forms 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, Pharmacy or similar.
  • +5-10 years of experience of development and manufacturing of Drug Substance small molecule, non-sterile dosage forms for clinical and commercial use.

Skills/Knowledge/Languages

  • Scientific and technical background of CMC development and manufacturing in Drug Substance small molecule, non-sterile products.
  • Recognized expert in Solid and Non-Sterile dosage forms manufacturing.
  • Demonstrable experience of working in cross-functional teams with ability to multi-task, prioritize and be an effective decision maker.
  • Experience of regulatory guidelines, regulatory authorities communication and file documentation.
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.

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