Senior Process Manager DS Biologics
Senior Process Manager DS Biologics
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Job Description
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 Sobis 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 Sobis 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 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.
- 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.
Qualifications :
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
Additional Information :
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 fastgrowing 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 decisionmaking 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
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
