Senior Process Manager MSAT
vor 1 Monat
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
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.
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.
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.
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