Thomas Perch Groth Email & Phone Number

Denmark

Denmark

Måløv, Capital Region, Denmark

Global Research Technologies Strategy & Operations

Ballerup, Capital Region, Denmark

• R&D Business Excellence, R&D Management
• Leading strategic cross-functional optimisation, transformation, and change management projects in close collaboration with stakeholders in the R&D VP areas
• PMO lead on the R&D Business Excellence project pipeline with focus on executing strategy, strengthening effectiveness & efficiency, removing bottlenecks, and fostering “Enterprise Thinking” across R&D, by building.

Ballerup

• Pharmaceutical Product Support, CMC Device & DevelopmentManagement and development of a department of 13 FTEs (life science academics) doing:
• Formulation expert input to early and late stages of pharmaceutical development
• CMC input to regulatory documentation
• Root cause investigations related to primary packaging and formulation of marketed products
• Expert scientific statements and reports to support the Life Cycle Management of marketed products
• Preparation of protocols for extractable studies

Bagsværd, Denmark

CMC API Planning and OptimisationMember of the CMC API Pilots management team. Responsibilities include supporting line management (corporate vice president and directors), and driving cross-departmental optimisation/simplification projects within quality, governance, GMP, and business and strategy processes.

Måløv, Denmark

CMC Oral Protein FormulationConducted an optimisation project within the oral GLP-1 area in CMC Development

Bagsværd, Denmark

• CMC API Development
• Created and developed a centre of excellence of QMS (GMP and non-GMP), LEAN, and training practices
• Expanded and lead a team of project managers (5 FTEs)
• Identified business critical improvements across a 500 people large CVP area in close cross-functional collaboration with stakeholders (leaders and specialists in development departments, CMC API pilot facilities, and.

Bagsværd, Denmark

• CMC API Development, CMC Development
• Ensured a constant exploration of synergies between LEAN, QMS (GMP and non-GMP), and training practices
• Ensured best practice and alignment of these areas’ agendas across four VP areas
• Drove LEAN leadership and improvement projects together with a network of VP area QMS, LEAN, and training responsible specialists

Måløv, Denmark

• CMC API Development, CMC SupplyManagement and development of deliverables and the team of 19 FTEs (highly skilled innovative and creative PhD chemists/specialists and synthesis technicians). Team deliverables:
• Developing chemical processes from research scale to pilot plant scale in CMC early and late-stage development: synthetic peptides, side chain reagents, side chain acylation of peptide and proteins
• Synthesis of API starting materials and pre-clinical batches
• Process transfer from research. Transfer to external CMOs and CMC API pilot plant
• Establishment of the use of flow chemistry for side chain acylation in CMC Development
• Process documentation and Q&A handling from health authorities

Måløv, Denmark

• CMC Drug Product Development, CMC SupplyManagement and development of deliverables and the two teams of combined 20+ FTEs:
• Structural characterisation of peptides, proteins, and side chains
• Chemical analyses of leachables and unexpected impurities in production processes
• Analytical method validation
• Filing documentation and handling of Q&A from health authorities

CMC Analysis and Formulation, CMC Supply

R&D Business Support, Strategic R&D

Clinical Business Support, Global Development

Clinical Business Support, Global Development

Ph.D., Organic Chemistry

Solid phase chemistry, combinatorial chemistry, and methodology development, under the supervision of Nobel Laurate Prof. Morten Meldal..

M.Sc., Chemistry

Educational focus: organic chemistry and mathematics Master theses titles: Part 1: Carbapenem Synthesis – An Aziridine Precursor, Grade.

Bachelor Of Business Administration (Hd), Accounting Management And Process Control

Education record

Education record