Principal Scientist Formulation Development (m/f/d)
Who we are
ProBioGen is an internationally active biopharmaceutical CDMO based in Berlin. We support biotech and pharmaceutical companies in the development and manufacturing of complex biopharmaceuticals, from recombinant proteins and antibodies to viral vectors and vaccines.
To expand our Formulation & Developability activities, we are seeking experienced scientific expertise to independently design and lead customer projects while contributing to the strategic development of our service offering.
As Principal Scientist Formulation Development, you will be responsible for customer-specific formulation, developability, and stability projects from technical assessment through final recommendation. You will design tailored, product- and phase-appropriate development programs that balance scientific requirements with material availability, timelines, manufacturability, and customer needs.
What you create
- Develop tailored project and study strategies based on drug-substance characteristics, development phase, target product profile, material availability, timelines, and CMC-relevant risks.
- Lead formulation, developability, and stability projects across biopharmaceutical modalities, including antibodies, recombinant proteins, viral vectors, and vaccines.
- Design screening, optimization, high-concentration, stress, and stability studies and apply Design of Experiments (DoE), statistical modeling, and multivariate analysis to support efficient decision-making.
- Integrate biophysical, chromatographic, electrophoretic, and particle-analysis data into a robust product understanding and translate the results into formulation decisions and de-risking actions.
- Incorporate relevant processability and drug-product requirements early in development, including concentration, filtration, freeze/thaw, mechanical stress, storage, and fill/finish considerations.
- Act as the scientific point of contact for international customers and represent formulation development in project assessment, study design, data discussions, and final recommendations.
- Provide scientific leadership across interfaces and collaborate closely with Analytics, Downstream Process Development, QC, Manufacturing, CMC, and Project Management.
- Advance the Formulation & Developability platform by evaluating new methods and technologies and establishing more efficient, data-driven, and automated development and analysis workflows.
- Monitor scientific, technological, and market trends, assess emerging customer needs, and translate them into potential new formulation and developability services, study concepts, and technology offerings.
- Together with Business Development and relevant internal functions, assess the scientific and business potential of new capabilities and support their translation into clearly defined, scalable service offerings.
- Work with Business Development and Marketing on the scientific positioning and promotion of the Formulation & Developability offering, for example through technical content, customer presentations, white papers, webinars, and conference contributions.
- Provide technical leadership and mentoring and strengthen scientific decision-making and methodological expertise within the team.
What you bring along
- University degree in biochemistry, biophysics, biotechnology, pharmacy, chemistry, biology, or a related scientific discipline; a PhD is preferred.
- Several years of relevant industry experience in formulation development, developability, stability assessment, or drug product development of biopharmaceutical drug substances and products.
- Strong understanding of the physicochemical principles governing the stability of biopharmaceutical drug substances, including relevant degradation, aggregation, interaction, solubility, and colloidal stability mechanisms.
- Experience in formulation development of biopharmaceutical drug substances and in the rational use of buffers, excipients, stabilizers, and surfactants; experience with proteins, antibodies, viral vectors, or vaccines is particularly relevant.
- Experience with DoE, statistical experimental design, and data-driven development; knowledge of JMP or comparable software is an advantage.
- Strong understanding of modern biophysical and stability-indicating analytics and the ability to integrate orthogonal data into clear development decisions.
- Experience in the scientific leadership of complex, interdisciplinary projects and in direct interaction with customers and internal stakeholders.
- Ability to assess scientific and technological developments for their practical and commercial potential as new services.
- Excellent communication and presentation skills and excellent written and spoken English; good German skills are an advantage.
Additional advantages include experience in a CDMO or CRO environment, with high-concentration biologics, viral vectors, or vaccines; knowledge of regulatory and CMC requirements; and experience with automation, data science, technology assessment, or building new scientific service offerings.
What you can expect
ProSphere. Partnership environment, company events ProBalance. Flexible workschedule and special vacation days ProHealth. Yoga, Shiatsu, health days and discounted membership in the Urban Sports Club ProCare. Technical equipment, laboratory clothing, monitor glasses, company pension plan ProTaste. Cafeteria with Convini fridge, daily fresh lunch specials and free drinks ProTalent. Onboarding with mentoring program, innovation days, further training opportunities
Whom to ask
Every talent is welcome! Apply now via our online form! Do you have any questions? I will be happy to help you.