Tübingen, Baden-Württemberg, Germany
I help teams finding solutions throughout the product development. Pharmaceutical researcher with 10+ years of experience with passion for CMC. Successful track record on: - End-to-end product development (Ophthalmics and Injectables); - QbD - project risk-assessment, DoE and control strategy ; - End-to-end product development; - Project management.
- Set up strategic concepts for product and process development (e.g. CMA, CPPs, FMEA, control strategy). - Contribute to key CMC concepts for different mRNA-based products (IMPD/IND, briefing book, personalized medicines). - Build departmental structures for performance management, increase productivity and continuous improvement. - Lead root-cause investigations related to product development and manufacturing performance. Propose and implement CAPAs. - All attributions as Manager Process Development with larger team (3 sub-teams - 15 individuals).
- Guide the development and optimization of GMP-compliant, scalable manufacturing process for production of RNA products. - Plan, supervise, monitor and control technology projects for manufacturing and process control of mRNA-LNPs. - Support process transfer of mRNA vaccines to different manufacturing sites, and scales. - Manage a team of scientists, engineers and technical assistants.
Responsible for end-to-end development of complex generic product (i.e. injectable and ophthalmic suspensions/nanosuspensions/liposomes/hydrogels). The main responsibilities being: - Resource management & Product delivery. Lead the product development effort from initial strategy to launch, in line with the business priorities - quality, cost and timelines - ensuring the product is robust, stable and scalable. Look for opportunities for process improvement of process and optimization of resources; - Tech Transfer. Lead transfer of product to FTO sites or to Late Stage Development based on product requirement. - Coach & Mentoring. Coach and mentor a multidisciplinary and multicultural team compose of formulation and analytical scientists. Enhancement of the overall scientific competence and capability of the site and team. Active participation in recruitment, selection, performance of team. - Compliance. Track and drive compliance to quality, safety and regulatory requirement. - Continuous Improvement. Look for opportunities for process improvement and optimization of resources. Assess business opportunities with new technologies for complex 505B2 products. - Internal and External relationships. Actively interacts with internal cross-functional teams for closure of requirements for project. Facilitate and strengthen the interaction with different sites. Interaction with external CFT on all technical issues.
Same responsibilities and attributions as for Tech Lead position.
Responsible for the formulation and process development of complex ophthalmic formulations to enable successful scaling up. Key responsibilities are: - Formulation Development. Guide team in prioritization of the best POC design for product in consultation with experts. Design, plan and execute process optimization trials for small scale PoC, ensure the robustness of the process, respond to deficiencies with proper justification - Regulatory support. Conduct phase-wise drafting and compilation of regulatory documents and data as per project requirements. - Facilities. Ensures suitability of small/intermediate scale equipment train, including URS writing. - Coaching & Mentoring. Provide guidance to Operators/Engineers/Technicians/Interns in setting up experiments. Key skills involved: Approaches of Quality-by-Design (QbD), Statistical testing, Quality awareness, Stakeholder management, Influencing leadership, Critical and integrative mindset, risk assessment.
Responsible for the early development of liquid formulations for small molecules having semi-fluorinated alkanes (SFA) as main excipient: - R&D. Design, execute and evaluate experiments/studies, presenting results to senior management. Responsible for feasibility of several formulation within the company pipeline for glaucoma, AMD, cataract and blepharitis. - Cross team collaboration. Scientific support for formulation challenges to other teams, including successfully ensuring stabilization of EvoTears(r) Omega (licensed to UrsaPharm). Technical support for the outsourced steps of the development. - Explore the use of semi-fluorinated to other routes of administration (e.g. dermal drug delivery). Generate new IP for new SFA applications. - Coach and mentor of other formulation scientists in the ophthalmic drug product development, including hands-on training on relevant techniques in vitro and ex-vivo techniques. - Build in-house capability to execute in-vitro and ex-vivo animal studies, including CAPEX proposal, equipment installation and training.
Projects: (a) Development of liposomes to associate siRNA sequences to silence key genes of Acanthamoeba spp. (b) Development of dermal formulations using extracts from Brazilian plants. Responsibilities: - Design and execute experiments with with proper documentation. Collect and interpret data from experiments conducted. Explore new IP opportunities within the ophthalmic drug delivery front. Interact with the scientific community to expand understanding on the drug delivery systems and reporting results (e.g. conferences and papers). - Coaching and mentoring students in the manufacturing and control of colloidal DDS and cell culture (including international MSc. student of Charite Berlin). Lecturer at the School of Pharmacy (Pharmaceutical Technology; Production and Control of Solid Dosage Forms; Production and Control of Liquid Dosage Forms). Advising and mentoring of M.Sc. and undergraduate students. - Facilities. Responsible for building capability in human cell culture (immortalized lines) and liposomal manufacturing at small scale.