Senior Process Manager (DS Biologics)

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.

Manufacturing Science and Technology (MSAT) is part of the Global CMC, Science & Technology Department (GCSAT). GCSAT is responsible for optimization and life cycle management of Sobi's clinical and commercial manufacturing processes from internal and external network. MSAT ensures compliant, reliable, cost effective and sustainable manufacturing of our products now and in future. The MSAT team holds the senior scientific and technical knowledge for the manufacturing of Sobi's clinical and commercial products and is responsible for always keeping the internal and external manufacturing processes in a validated stage.

Key Responsibilities: 

Including, but not limited to the following:

• Subject matter expert (SME) for DS Biologics.
• Process owner of DS validation for Sobi products.
• Lead and execute MSAT projects such as manufacturing process and cost improvement as part of LCM.
• 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.
• Support in sourcing evaluation of new DS 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 DS 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, Biology, Biotechnoclogy, Pharmacy or similar.
• +5 years of experience of development and manufacturing of DS for clinical and commercial use.

Skills/Knowledge/Languages

• Scientific and technical background of CMC development and manufacturing of Drug Substance.
• Recognized expert in drug substance 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

Personal Attributes

• Fullfillment of all of Sobi CARE values
• Ability to act independently and take initiative
• Good communication skills, oral/written and listening
• Strong team player

Personal Attributes

• The role is likely to suit someone with an outgoing personality, who enjoys building things as part of a team and who is not afraid of the unknown. Ambiguity is a characteristic of a fast-growing organization and the successful candidate is likely to be someone who thrives on change and on the possibilities created by a changing environment.
• Significant drive and enthusiasm should be a prominent part of your character
• A strong team player, with demonstrated decision-making abilities
• Highly developed interpersonal skills, and the ability to build and maintain networks both externally as well as internally
• Structured and organized approach, in a flexible and adaptable spirit
• Highest levels of personal integrity, with a strong personal commitment to adhere to all rules, regulations, standard operating procedures and the values and ethics, compliance to rules and regulations
• A facility and ease in communicating in a scientific environment and with specialized audiences