Responsible for leading downstream process development and validation activities to develop and optimize antibody and non-antibody protein biosimilar molecules purification processes and define process parameters, limits and ranges Provide technical and scientific leadership for team of technicians and analysts involved in downstream process development for development and optimization of any single unit operation such us PrA, IEX, HIC, and filtrations of antibody and non-antibody protein biosimilar molecules;
prioritizes group tasks and manages resources in order to meet organizational goals. Lead or contribute as a key member of the department for interacting extensively with process development group and other departments of the company.
Management of downstream projects from the earlier development to process scale up (I) with demonstrated successful track record (II, III).
Coordinate internal resource related to the downstream laboratory with proven leadership skills (II, III).
Leads lab operations of standard downstream steps such us affinity, ion-exchange, hydrophobic and size-exclusion chromatographs as well as nanofiltration, depth filtrations and tangential filtration.
Develop and optimize of downstream processes of antibody and non-antibody protein biosimilar molecules to meet the regulatory guideline in term of quality product and impurities related to the process.
Contribute in validations / characterization activities and downscale model execution & qualification (III).
Good knowledge of stepwise of early development for therapeutic recombinant monoclonal antibodies (biosimilar drugs) (III).
Reporting and keeping updated project activities and redaction of Standards Operating Procedures, development and qualification reports.
Designs experiments, analyzes data, and draws conclusions. Ensures accurate and complete documentation of lab activities to ensure appropriate regulatory submission.
Writes technical reports for tech transfer and regulatory submission.
Implements QbD (quality by design) approaches and utilize DoE (design of experiment) for experimental planning, data analysis.
Working according to GLP standards.
Continuous Improvement - will support process improvements throughout the development process.
Requirements and personal skills
Education : Degree in relevant Biochemistry / chemistry specialty, Phd is a plus or +8 years as Downstream Technician.
Languages : Fluent Spanish, working knowledge in English, knowledge of other languages will be an asset.
Experience (years / area) : +1 (I), 3-6 (II) or +6 (III) years of relevant expertise in the downstream activities working with biologics pharmaceuticals and biotech environments.
Specific Knowledge : Expert in development and optimization of downstream steps such us affinity, ion-exchange, hydrophobic and size-exclusion chromatographs as well as nanofiltration, depth filtrations and tangential filtration.
Qualification and validation of downstream unit operations. Good understanding of guideline requirement in term of purity and impurities target.
High understanding of structure, function and post-translation modifications of monoclonal antibodies (biosimilar drugs) as well as standard purification platform of monoclonal antibodies (II, III).
Notable hands on viruses clearance study and guideline requirements (II, III). Understanding (I) or Expertise (II, III) in QbD, PAT guidelines for process development and scale up.
Knowledge of cGMPs as applied to process development and scale up.
Travels : Not required.
Personal skills : High level communications skills with other departments. Excellent problem solving skills as well as time management and organizational skills.
Must have strong verbal and written communication skills. Ability to communicate effectively with others internally (up, down, and laterally) and externally to the organization.
Willingness to work extended and, at times unusual hours to meet business needs.