Objectives

The Scientist will be involved in the development of Hilleman Laboratories pipeline products (including vaccines, mAbs, and recombinant proteins). Responsibilities include development of a robust formulation for drug substance and drug product discovery till phase 2 clinical development as well as development/tech transfer of scalable and robust drug product manufacturing process from early phase to process validation. The individual will provide technical guidance for formulation and drug product development efforts, author technical protocols, design and implement experimentation, generate technical reports, and author related CMC sections to support regulatory submissions.

The Scientist will closely collaborate with Process Development, analytical development, quality control and quality assurance. The individual will also interface with external contract organizations as required.

Responsibilities

• Provide technical expertise in execution of vaccines and biologics product formulation development.
• Provide technical expertise for clinical drug product process development / engineering and clinical drug product manufacturing support.
• Author/review development documents and support regulatory submissions and responses.
• Represent drug product development within cross-functional project teams.
• Design and execute phase-appropriate DP formulation development, process development, process characterization, and process validation studies.
• Assist with development of project strategy and communicate complex data/decisions within department and cross-functionally as necessary.
• Assist with various laboratory operations in the development and application of analytical methods for biologics and biopharmaceuticals such as Mab, recombinant proteins, bacterial and/or viral vaccines.
• Assist with conducts of experimental procedures to establish, optimise, and qualify analytical methods for in-process control samples and product release.

Education, Experience, Knowledge And Skills

• Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering or related pharmaceutical science and 8+ years of relevant industry experience.
• Master’s degree in Chemistry, Biology, Pharmacy, Engineering, or related pharmaceutical science; 6+ years of relevant industry experience.
• PhD in Chemistry, Biology, Pharmacy, Engineering, or related pharmaceutical science; 4+ years of relevant industry experience.
• Bachelor’s or Master’s: Extensive experience in CMC development for active pharmaceutical ingredients and drug products under cGMP.
• Sound knowledge of current Good Manufacturing Practices (cGMP).
• Prior experience in the use of contract facilities.
• Experience working in a multi-disciplinary team environment.
• Familiarity with current applicable scientific literature and applicability to various projects.
• Ability to investigate and develop new processes and technologies for project advancement.
• Well-organized and detail-oriented, with ability to effectively prioritize tasks, eager to learn, interact cooperatively and effectively with others in a team environment, and consistently demonstrate reliability and responsibility.
• Experience with Statistics and Design of Experiment (DoE) applied to an applied research and development and industrial biopharmaceutical environment will be a distinct advantage.
• Team player with initiative & drive.
• Strong verbal and written communication skills.
• Comply with laboratory safety practices and standard operating procedures.
• Experienced and demonstrated track record in biopharmaceutical development including, but not limited to drug product development, drug product process characterization, QbD, control strategy, and validation.
• Good understanding of protein degradation and stabilization strategies.
• Good understanding of CMC management with involved function areas to drive and meet deliverables in the matrix environment and cross-functional improvements.
• Preferably, experienced in lyophilization and/or combination drug product development with a good understanding of the inter-relationships among formulation parameters, process parameters, device performance, product delivery, and quality.
• Excellent communication, technical, organizational, interpersonal, and leadership skills are required.
• Must be a team player prepared to work effectively and efficiently in a team-based environment.
• Critical evaluation of results and ability to defend strategic guidance to resolve technical issues.