Senior Process Manager MSAT
Senior Process Manager MSAT
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
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 oversees 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.
- 510 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 Sobis 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 1700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our daytoday wins and a Board with a stellar track record were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre 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 firsthand 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 groundbreaking 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 cant 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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Remote
Company Industry
Key Skills
- Loan Processing
- Continuous Improvement
- Lean
- Management Experience
- Math
- Process Improvement
- Fair Housing Regulations
- Project Management
- Process Management
- Underwriting
- Leadership Experience
- Supervising Experience
