Senior Scientist, Associate Director, Director, VP of Biomedical Research
The position will have broad expertise in the development of diverse biologics modalities (mAbs, proteins, conjugated proteins, multi specific formats) and dosage forms with associated formulation and process technologies for high-concentration protein formulations, pre-filled syringes, cartridges, and larger volume, liquid and lyophilized, formulations.
They will have demonstrated such leadership through commercialization of multiple Biologics Drug/Combination products. They will also possess exceptional people-management skills, articulate in oral, formal and presentation communications, be able to operate in complex and diverse professional environments, and have experience with change management.
- D. in Biology, Biochemistry, molecular biology, Chemical engineering, Biotechnology, Bioengineering, Pharmaceutical Sciences or a related discipline;
- 12+ years professional experience in development in the biopharmaceutical industry with demonstrated expertise in Biologics Drug Product Development and experience in development through commercialization of Biologics drugs. At least three years of experience with managing formulation and process development teams;
- Experience spanning early and late-stage stage aspects of Biologics Formulation & Drug Product development;
- Late-stage experience in scale-up, and technology transfer of Biologics Drug Products (Liquid, lyophilized, pre-filled syringes, cartridges) through commercialization.
- Knowledge of Drug Substance development work flows for Biologics (Cell Line, Cell Culture, Purification, Fermentation,);
- Strong background in anticipating needs of injectable commercial manufacturing organizations;
- Thorough knowledge of current regulatory expectations and demonstrated experience of successful licensures;
- Ensure appropriate technical, scale-up and production strategies and timelines are in place;
- Ensure production, technology transfer, validation and regulatory outcomes meet or exceed industry standards
- Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
- Provide sound scientific and technical leadership and advocacy to support the development of robust manufacturing processes and products, integrating current regulatory and industry standards
- Established record of internal and external science and technology influence demonstrated through publications, patents, and presentations;
- Open and engaging personality and the ability to work successfully with a dynamic team and diverse stake-holders within the Biologics network;
- Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations
- Flexibility to undertake some traveling.
Interested candidates should submit their resumes to firstname.lastname@example.org