Drug Substance Manufacturing Process Lead
vor 1 Monat
Job Overview
">The Senior Process Manager will be responsible for overseeing the manufacturing process of Drug Substances at Sobi. This role involves ensuring compliance, reliability, cost-effectiveness, and sustainability in our production processes.
">About Us
">Sobi is a global biopharmaceutical company dedicated to improving the lives of patients with rare diseases. Our team is passionate about innovation and collaboration, working together to develop and manufacture life-changing treatments.
">Key Responsibilities
">- ">
- As a Subject Matter Expert (SME) for DS Biologics, you will lead cross-functional teams to optimize manufacturing processes and ensure compliance with regulatory requirements.">
- You will own and execute MSAT projects, such as manufacturing process and cost improvement initiatives, to drive business growth and efficiency.">
- Participate in internal activities related to manufacturing, including process changes, deviations, risk assessments, and CAPAs.">
- Issue, review, and approve applicable SOPs and manufacturing instructions to maintain quality standards.">
- Review and supervise technical studies, qualifications, and validations to ensure accuracy and compliance.">
- Contribute to the development of new analytical specifications and stability programs and review changes thereof.">
- Write and review applicable sections of the APR/PQR and registration files, variations, and market expansion.">
- Support sourcing evaluations of new contract manufacturers and participate in developing supply and quality agreements.">
- Lead the technical part of product transfers, scale-up activities, validations, and oversees manufacturing at external manufacturers for Sobi projects in clinical and commercial phases.">
- Stay up-to-date with external biopharmaceutical manufacturing technology advancements and introduce new technologies to improve processes, costs, or yields.">
Qualifications and Requirements
">- ">
- A university education in Chemistry, Biology, Biotechnology, Pharmacy, or a similar field.">
- At least 5 years of experience in development and manufacturing of DS for clinical and commercial use.">
- Scientific and technical background in CMC development and manufacturing of Drug Substances.">
- Recognized expert in drug substance manufacturing with demonstrable experience in cross-functional teams.">
- Regulatory knowledge, communication skills, and fluency in English.">
- Personal attributes: fulfillment of Sobi CARE values, ability to act independently, good communication skills, strong team player, and personal integrity.">
Salary and Benefits
">This position offers an estimated salary range of $120,000 - $180,000 per year, depending on location and experience. Additionally, Sobi provides comprehensive benefits, including health insurance, retirement plans, and opportunities for professional growth and development.
">Location
">This role is based in [insert location], with occasional travel required for meetings and training sessions.
">What We Offer
">We offer a dynamic and supportive work environment, where you can grow your career and make a meaningful impact in the lives of patients worldwide.
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