Req ID: 5321
Date: Oct 26, 2020
LEON (GENHELIX), León, ES
Business Unit: Mabxience
Responsible for leading formulation process development activities. Provide technical and scientific leadership for team of technicians and analysts involved in formulation process development for development 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.
Management of formulation activities from the earlier development to process scale up (I) with demonstrated successful track record (II, III).
Design pre-formulation screening studies, stability studies, forced degradation studies, drug product device testing studies and in-use drug product stability studies.(II, III).
Leads activities of stabilities studies (long term, stress, accelerated and force degradation) (III).
Assist in drug product development/fill & finish activities.
Develops and optimizes buffer formulations.
Reporting and keeping updated project activities and redaction of Standards Operating Procedures, development and qualification reports.
Prepare technical reports timely and efficiently, including presentation of data in group meetings.
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 and development.
Working according to GLP standards.
Continuous Improvement – will support process improvements throughout the development process.
Requirements and personal skills
Education: Degree in Chemistry, Pharmaceuticals, Biochemistry or Biology. Phd is a plus.
Languages: Fluent Spanish and English, knowledge of other languages will be an asset.
Experience (years/area): 1-3 years of analytical experience relevant to the role. A hands-on analytical background is required, with previous experience in standard protein analytical techniques (SDS-PAGE, CE-SDS, IEF, cIEF, RP-HPLC, SEC, IEx-HPLC, HIC) to evaluate protein formulated product.
Specific Knowledge: Previous knowledge and hands-on experience with biophysical characterization techniques including DLS is a plus, including sub-visible particulate analysis by MFI.
Travels: Not required.
Personal skills: Ability to work successfully under appropriate supervision using scientific judgment and professional competency.
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