Senior Scientist, Drug Product, Manufacturing Science and Technology
Senior Scientist, Drug Product, Manufacturing Science and Technology
Sobi
Basel, Geneva or Stockholm
Sobi is looking to recruit a Senior Scientist for Drug Product within our Manufacturing, Science and Technology (MS&T) department. MS&T holds the senior scientific and technical knowledge for the manufacturing of our clinical and commercial products. MS&T drives the development and life cycle management for our manufacturing processes in both our internal and external manufacturing network and ensures compliant reliable, cost effective and sustainable manufacturing of our products.
Key Responsibilities:
- Act as Subject Matter Expert for Biological Drug Product development and manufacturing processes,
- Responsible for Life Cycle Management of commercial DP
- Responsible for continuous process verification (i.e. assure CMO perform relevant data trending and responsible for trending data under Sobi responsibility, i.e. release data) and involved in annual product review activities
- Responsible for process optimization where required/possible
- Involved in or lead implementation of new presentations, scale ups, major process changes, site transfers etc. for existing products at external manufacturers
- Participate in or lead internal activities related to external manufacturing such as process changes, major/critical deviations and CAPAs
- Support identification and evaluation of manufacturing partners within DP Biologicals
- Ensure that the applicable quality requirements for our pharmaceutical products are met
- Write, review and approve manufacturing instructions, annual product quality reviews (APR/PQR), applicable sections in registration files and variations, internal and external SOP´s, qualifications and validations.
- Provide manufacturing perspectives in development of new products and if required support the CMC teams during the late phase development
- Support technical due diligence activities as required
- Engage in external collaborations to strengthen Sobis resources
- Awareness of technology advancements, understand and introduce new technologies and how they may be applicable to process innovation, cost or yield improvement
Personal attributes:
The right candidate fulfills the following qualifications:
- University degree in Chemistry and/or Pharmacy and a minimum of 10 years of experience in the pharmaceutical industry
- Significant experience of Technology Transfers of Drug Product processes
- Strong scientific and technical background and experience of CMC development and manufacturing of Drug Product, Finished Good and IMP
- Experience of working in a cross functional matrixed environment and evidence of successful
- collaboration with internal and external parties.
- Experience of regulatory guidelines, regulatory authorities communication and file documentation
- Experience of cross functional teamwork and working in an international environment
- Excellent verbal and written communication skills in English and ability to communicate in a business environment
- Previous work involving direct contact with CMO´s is a merit
To be successful in the role you are driven, flexible and thrive in a role that requires both operational management and strategic overview. You have strong capabilities to analyze complex information or situations and provide sound solutions and to identify, adapt and implement new technologies.
You work independently and handle priorities in order to deliver business critical items in time. Strong team working skills are required to work effectively and establish/maintain effective working relationships with internal/external partners.
