Senior Process Manager MSAT

vor 17 Stunden

Basel, Schweiz Sobi Vollzeit
Company 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

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 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 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 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.
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.

An Equal Opportunity Employer
Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.

#J-18808-Ljbffr

  • Process Manager Msat

    vor 5 Monaten

    Basel, Schweiz Skillhubs Vollzeit

    Are you ready to make a difference in the lives of patients suffering from severe rare conditions? Do you dream of being part of a biopharma leader that's rewriting the narrative of medical advancement? Look no further - To support our client growth, we are looking for an **Manufacturing Science and Technology (MSAT) expert.** **Role & Function** The MSAT...

  • Msat Process Manager Small Molecules

    vor 5 Monaten

    Basel, Schweiz Sobi Vollzeit

    Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere. **Role &...

  • Senior Process Manager MSAT

    Vor 3 Tagen

    Basel, Schweiz Sobi Vollzeit

    Job DescriptionThe 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,...

  • Senior Process/Project Manager

    vor 4 Wochen

    Basel, Basel-Stadt, Schweiz St. Claraspital AG Vollzeit

    Job DescriptionAt St. Claraspital AG, we are seeking a highly skilled and experienced Senior Process/Project Manager to join our team. As a key member of our organization, you will be responsible for leading and managing projects to promote synergies and ensure the effectiveness of process optimizations across departments.Your key responsibilities will...

  • Senior Process Engineering Manager

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Triplan Ingenieur AG Vollzeit

    Jobbeschreibung: Als erfahrener Senior Projektingenieur bzw. Projektmanager leitest Du die Abteilung «Process Engineering» bei Triplan Ingenieur AG. Deine Aufgaben umfassen die Planung von Projekten von der Konzeption bis zur Umsetzung, teilweise direkt bei unseren Kunden vor Ort. Du koordinierst die beteiligten Interessengruppen (Kundenorganisation,...

  • Senior Process Engineer

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    Job Title: Senior Process EngineerWe are seeking a highly skilled Senior Process Engineer to join our team at Gi Group SA. As a key member of our team, you will be responsible for the development and optimization of isolation processes for peptides.Key Responsibilities:Collaborate with our in-house team to develop and optimize isolation processes for...

  • Senior Process Engineer

    vor 1 Monat

    Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    Senior Process EngineerWe are seeking a highly skilled Senior Process Engineer to join our team at Gi Group SA. As a key member of our team, you will be responsible for supporting the development and optimization of isolation processes for peptides.Key Responsibilities:Collaborate with our in-house team to develop and optimize isolation processes for...

  • Senior Process Engineer

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    Senior Process EngineerWe are seeking a highly skilled Senior Process Engineer to join our team at Gi Group SA. As a key member of our team, you will be responsible for the development and optimization of isolation processes for peptides.Key Responsibilities:Support the in-house team in the development and optimization of isolation processes for...

  • Senior Manager Accounting

    vor 4 Wochen

    Basel, Basel-Stadt, Schweiz Viking Vollzeit

    Job Title: Senior Manager AccountingViking is seeking a highly skilled Senior Manager Accounting to join our team in Basel, Switzerland. As a key member of our finance department, you will be responsible for ensuring the integrity of our accounting information and providing financial guidance to our leadership team.Key Responsibilities:External Audit:...

  • Strategy Manager, Process Automation

    vor 5 Monaten

    Basel, Schweiz ABB Vollzeit

    **Strategy Manager, Process Automation**: **Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gender, LGBTQ+, abilities, ethnicity and generations....

  • Senior Automation Manager

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Lonza Vollzeit

    At Lonza, we are seeking a highly skilled and experienced Senior Automation Manager to provide strategic and technical leadership in delivering large-scale capital projects across the European region (excluding Visp, Switzerland).The ideal candidate will have a deep understanding of automation systems, process controls, and manufacturing execution systems,...

  • Senior Cost Manager

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Turner & Townsend Vollzeit

    Job Title: Senior Cost ManagerJob Summary:We are seeking a highly skilled Senior Cost Manager to join our team in Switzerland. As a Senior Cost Manager, you will be responsible for managing complex projects in the Life Sciences sector and working in an international environment.Key Responsibilities:Develop, implement, and maintain cost management procedures...

  • Senior Process Engineer

    vor 3 Monaten

    Basel, Schweiz PM Group Vollzeit

    OverviewPM Group is a leading International engineering, architecture, project and construction management firm. With a network of offices in Europe, Asia and the US and a multi-discipline team of more than 3,500 people, we deliver complex capital projects in the pharma, life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy...

  • Process Engineer

    vor 1 Monat

    Basel, Basel-Stadt, Schweiz agap2 - HIQ Consulting Vollzeit

    About agap2 - HIQ Consultingagap2 - HIQ Consulting is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.Job DescriptionWe are seeking a skilled Process Engineer to...

  • Process Engineer

    vor 2 Monaten

    Basel, Basel-Stadt, Schweiz agap2 - HIQ Consulting Vollzeit

    {"h2": "About agap2 - HIQ Consulting", "p": "As a leading European engineering and operational consulting group, we specialize in the industry, serving clients in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors. Our team of experts provides support to clients in the realization...

  • Senior Process Engineer

    vor 3 Wochen

    Basel, Schweiz https:www.energyjobline.comsitemap.xml Vollzeit

    Overview PM Group is a leading International engineering, architecture, project and construction management firm. With a network of offices in Europe, Asia and the US and a multi-discipline team of more than 3,500 people, we deliver complex capital projects in the pharma, life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy...

  • Senior Process Engineer

    Vor 2 Tagen

    Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    **Job Title:** Senior Process Engineer - Peptide Development SpecialistWe are seeking a highly skilled Senior Process Engineer to join our team as a Peptide Development Specialist. The successful candidate will support the development and optimization of isolation processes for peptides, including precipitation, crystallization, spray drying, and...

  • Process and Compliance Manager

    vor 5 Monaten

    Basel, Schweiz NTT DATA Vollzeit

    **Req ID**: 258136 We are currently seeking a Process and Compliance Manager to join our team in Basel, Basel-Stadt (CH-BS), Switzerland (CH). Overall, the role of the Data Migration Process & Compliance Manager is to: - Understand Data Migration Program strategy and associated defined processes. - Understand European, pharmaceutical industry, financial...

  • Process and Compliance Manager

    vor 5 Monaten

    Basel, Schweiz Hashmap Vollzeit

    **Req ID**:258136 We are currently seeking a Process and Compliance Manager to join our team in Basel, Basel-Stadt (CH-BS), Switzerland (CH). Overall, the role of the Data Migration Process & Compliance Manager is to: - Understand Data Migration Program strategy and associated defined processes. - Understand European, pharmaceutical industry, financial...

  • Senior Manager Accounting

    vor 1 Monat

    Basel, Basel-Stadt, Schweiz Viking Vollzeit

    Job Title: Senior Manager AccountingViking is seeking a highly skilled Senior Manager Accounting to join our team in Basel, Switzerland. As a key member of our finance department, you will be responsible for ensuring the integrity of our accounting information and providing financial insights to support business decisions.Key Responsibilities:Ensure accurate...