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For a late-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics, we are currently looking for a Process Engineer.
To further strengthen their CMC team, we are looking for an experienced and motivated CMC scientist/ senior Scientist Process Engineer. The scientist/ senior scientist CMC will play a lead role supporting technology transfer of the drug substance (DS) manufacturing process to multiple large scale external manufacturing partners (CMOs) to enable rapid scale-up, process characterization, qualification and commercial manufacture of therapeutic antibodies and Fc engineered molecules.
KEY ACCOUNTABILITIES AND RESPONSIBILITIES:
- Work with internal and external leads and SMEs from the Drug Substance, Drug Product, Supply chain, Quality, Analytics and Manufacturing excellence teams to provide technical expertise in technology transfer activities of drug substance processes (upstream and downstream) to external manufacturing sites.
- The role will require technical leadership in early / late stage programs.
- To support the on-going optimization of the upstream/downstream processes.
- Serve as Manufacturing /Technical first point of contact on specific workstreams, leading teleconferences with CMOS and internal teams, following up with stakeholders on action items etc.
- Desired hands-on experience in chromatography, Viral inactivation, Virus filtration and UF/DF operations.
- Knowledge of Delta V / MES desired.
- Experience in transferring processes and process troubleshooting to large scale manufacturing facilities.
- Support drafting, review and approval of tech transfer and manufacturing documentation such as risk assessments, gap analyses, batch records, process descriptions, and sample plans.
- Update project dashboards/presentations with project status to provide timely communication of status to internal team.
- Work with CMOs to compile and trend DS manufacturing process data during tech transfer and manufacturing campaigns.
- Facilitate the establishment of integrated CMC operational plans with internal and external service providers by providing expert input, problem resolution definition and priority setting and oversee their execution, scope and budget.
- Support, prepare and review CMC DS sections to support timely submission of clinical trial applications and (s)BLA/MAA/J-MAA filings, amongst others;
- As a member of the CMC team actively contribute to technical and strategic CMC discussions;
- Proactively identify and track project critical path items ‐ identify risks & knowledge gaps, work with the teams to formulate, develop and monitor corrective actions and communicate risk to CMC leadership;
- Work in close collaboration with quality assurance to ensure activities are performed in line with the required quality standards;
- Provides input to budget forecast cycles.
- Masters / PhD in chemistry, pharmaceutical sciences, bio‐engineering, or other discipline within pharmaceutical / biotechnology sciences
- Ability to lead tech transfer activities and previous experience in this area is desired.
- Strong technical expertise in the field of biological drug substance manufacturing, tech transfer, scale up, process characterization and process validation
- Expected experience: >3y within relevant industry
- Desire to work in a fast-paced environment, and relevant experience in managing outsourced projects with external vendor
- Ability to provide hands-on problem-solving skills and strong critical thinking.
- Excellent organizational and coordination skills;
- Ability to provide attention to detail whilst keeping the view on the overall project goal;
- Strong technical expertise combined with good interpersonal skills and ability to communicate effectively with internal and external stakeholders;
- Flexible attitude, capable to balance multiple priorities;
- Quality conscious attitude;
- Experience and knowledge in the preparation of regulatory submissions;
- Able to operate in a dynamic surrounding of a fast-growing biotech company with challenging timelines;
- Fluent in English, written and spoken
- In depth knowledge of ICH and GMP regulations;
- Works independently within the scope of his assigned field and supports others;
- Keep abreast with relevant scientific and/or technical developments. Searches literature and other sources independently and applies knowledge;