Philipp Höfer Email & Phone Number

Hanover, Nds, De

Mainz, Rhineland-Palatinate, De

Department head providing strategic leadership to CMC enabling teams:- CMC Excellence & Stragey- CMC Manufacturing Technologies- CMC Business Services- CMC CoordinationTogether, we aspire to enable CMC development by offering specialized expertise and designing streamlined processes that help our colleagues to get connected and accelerate product development.

Mainz, Rhineland-Palatinate, De

Built a department from scratch that provided subject matter expertise and innovative concepts for collaboration to the global CMC development orgnization amidst unprecedented growth.

Mainz, Rhineland-Palatinate, De

- Built a team of senior subject matter experts to oversee external protein development projects- Strategized protein development activities

Mainz, Rhineland-Palatinate, De

- Led and strategically advises technical development programs- Acted as senior expert on resolving CMC issues- Provided guidance for fostering the internal collaboration between technical development and regulatory affairs- Drove the development of the CMC strategy and technology innovation- Led Module 3 related due diligence activities

Abbott Park, Illinois, Us

Chemistry and manufacturing control: cross-functional lead for early stage DS manufacturing development of enzymes and hormones; CMC expert for biological products within Abbott’s pharma divisionKnowledge management: initiator and lead for an Abbott-wide cross-divisional community of practice on biologicsChange management: active engagement in a change program rollout at an Abbott manufacturing site (value stream mapping, GEMBA, Kaizen methodology); development of a Hanover site-related transformation concept/planOperational excellence: co-supervision of a green belt six sigma project, active promotor of close collaboration between development and operations

Technical lead for DS development of Pelmeg (biosimilar to Neulasta),reporting to the global program teamManagement: technical biosimilar development and CMC activities according toquality, time and budget; chemistry manufacturing control (CMC) activities;supervision of international contract research, development and manufacturingorganisations; management of external staff; coordination and lead of internal andexternal project experts; steering of decision making processesStrategy and business: set-up of technical development program (DS) andembedment into global biosimilar program; support of due diligence and partneringactivitiesPrimary subject matter expert: cell line and process development; FMEA riskassessments; process characterisation and validation; reference materialsQuality expert: Good Manufacturing Practice (GMP) compliance; co-auditor forPelmeg manufacturing processRegulatory support: review and editing of quality modules (CTD); participation inscientific advice meeting; quality responsible for Pelmeg MAA

Schrobenhausen, De

- Project and product management- Manufacturing engineering and functional specification- Coordination of qualification activities- Support of sales as technology lead- Cross-functional management support- Member of the R&D Advisory Board of Bauer Resources GmbH

Laupheim, Baden-Württemberg, De

Team leader and project manager for the establishment of new upstream processing technologies:- CHO-based process development under the aspect of Quality by Design (fed-batch and perfusion)- Process Analytical Technology- Spectroscopic (Raman, Fluorescence, UV/Vis) and multivariate process monitoring and control- Media and feed development- Critical evaluation of new technologies including single-use technologies- Knowledge management

Rio De Janeiro, Rio De Janeiro, Br

Sub-project leader: - Process development for the production of vaccines in adherent VERO cellsAuthoring of a development project proposal for the scale up of yellow fever virus production in bioreactors.

Montreal, Ca

Second generation polyhydroxyalkanoates were designed to combine functionality and material properties that are desired for fine applications in regenerative medicine. Genetically modified Methylobacterium extorquens strains were screened for their capability to form the functionalized biopolyesters designed. The most promising candidate was chosen for fermenter studies. The production was scaled up to reach yields that allowed for initial material characterization.- Design of second generation biomaterials- Metabolic and genetic engineering of bacteria for the production of biomaterials- Cultivation of bacteria in shake flasks and fermenters (20-150 L)- Bioprocess development- Structural and material characterization

Montreal, Ca

Development of a bioprocess for the production of hemp and flax fibers

Phd, Chemical Engineering

Biotechnology

Diplom-Biotechnologe (Msc), Biotechnology

Education record