Lead Upstream Late-Stage Bioprocess Development Scientist

AGC Biologics A/S; København; In loco; DKK 850.000 - 1.100.000; Tempo pieno

Vantaggi offerti da questo lavoro

Mentoring arrangement

Canteen arrangement

Employee Club

Employee discount opportunities

Descrizione del lavoro

AGC Biologics is seeking a Senior Scientist to lead upstream late-stage development activities, focusing on process characterization, down-scale model qualification, and data analysis. You will guide studies from design to reporting, act as SME for clients and internal stakeholders, and drive practical next steps based on scientific findings.

Responsibilities include planning PC studies, designing DSMQ, applying DoE and JMP, contributing to FMECA and risk assessments, supporting LIVCA, WCB,

Competenze

• Bachelor's/Master's/PhD in biotech, biochemical engineering, or related field.
• At least five years' industry experience with a Master's or two years with a PhD.
• Solid experience with mammalian cell culture, bioreactor operations and scale-up.
• Experience with late-stage process development, including characterization, scale-down models or tech transfer.
• Design studies, apply statistics, interpret complex data, and communicate conclusions.
• Experience with process risk assessments and scientific reporting.
• Fluent in written and spoken English.

Mansioni

• Plan and lead process characterization (PC) studies with data evaluation and reporting.
• Design and evaluate down-scale model qualification (DSMQ) studies for representativeness.
• Apply statistical methods, including DoE, and tools such as JMP to support conclusions.
• Contribute to FMECA and other risk assessments to identify critical parameters.
• Support late-stage development activities: LIVCA, WCB, scale-up and tech transfer.
• Provide scientific guidance to lab staff and communicate findings to clients.
• Contribute to development reports, technology transfer docs and regulatory submissions.

Conoscenze

Mammalian upstream processes

Bioreactor operations

Scale-up

Design of Experiments (DoE)

JMP

Statistical analysis

Regulatory documentation

Client communication

Formazione

Biotechnology / Biochemical Engineering degree

Strumenti

DSMQ

FMECA

AMBR250

Process modelling

DSMQ

JMP

Descrizione del lavoro

AGC Biologics is seeking a Senior Scientist to lead upstream late-stage development activities, focusing on process characterization, down-scale model qualification, and data analysis. You will guide studies from design to reporting, act as SME for clients and internal stakeholders, and drive practical next steps based on scientific findings.

Responsibilities include planning PC studies, designing DSMQ, applying DoE and JMP, contributing to FMECA and risk assessments, supporting LIVCA, WCB,