This positions hold important leadership roles, responsible for analytical and formulation development aspects of early and late stage clinical Biologics. and are directly responsible for analytical method development/qualification/validation, drug candidates’ characterization, formulation development and cGMP testing. This roles require managing direct reports, interacting with clients and close collaboration with other departments to support clients’ process development and manufacturing efforts.

Responsibilities include

• Leading analytical and formulation development programs to ensure proper integration of all project components for meeting sponsor timelines. Developing study protocols and experimental designs emerging protein drug candidates from research into preclinical and clinical studies.
• Developing, qualifying and tracking performance of analytical methods to deliver an integrated suite of high quality assays to support preclinical and clinical sample testing and formulation selection. Typical suite of methods include HPLC/UPLC, Capillary Electrophoresis, Imaged Capillary Electrophoresis, ELISA and particle counting/characterization (HIAC/MFI).
• Characterization of drug candidates with respect to drug substance and drug product identity, purity, structure elucidation and stability by applying analytical and biophysical methodologies.
• Formulation development for parenteral therapeutics evaluating the critical components by using one-factor-at-the-time and DOE approach.
• Performing and coordinating cGMP testing on product release and stability programs. Performing stability trending, provide support for troubleshooting and laboratory investigations.
• Managing laboratory personnel by providing technical leadership, performing in-depth data analysis and coordinating team efforts.
• Managing cost and timelines.

Requirements

• Degree in biophysical/biochemical sciences, pharmaceutical sciences, biochemical engineering, or other scientific discipline
• Experience managing laboratory personnel is required for both Project and Group Leader.
• For Group Leader position, previous experience in industry biopharmaceutical development is required. Ph.D. and 2 year experience, M.S. and 7 year experience, B.S. and 12 year experience
• Broad technical competence in protein-based analytics
• High level, independent problem solving of both technical and logistical project issues
• Experience working in a cGMP environment preferred, but not required

Interested? Please do not hesitate in sending your CV and/or the best contact details for yourself to info@thetechrg.com and our team of skilled consultants would be very happy to contact you with more details.