Objectives

The Scientist will be involved in the formulation and product development of Hilleman Laboratories pipeline products (including vaccines, mAbs, recombinant proteins). Responsibilities include development of robust formulation for drug substance and drug product discovery until phase 2 clinical development as well as development and supporting technology transfer of scalable and robust drug product manufacturing process to process validation with manufacturing partners. The individual will drive the execution of formulation and drug product development strategies, 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, 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 formulation science and drug product development within cross functional project teams
• Design and execute phase-appropriate DP formulation development, process development, process characterization, and process validation studies
• Execute development of project strategy and communicates complex data/decisions within department and cross functionally as necessary
• Assist in 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 conduct of experimental procedures to establish, optimise and qualify analytical methods for in-process control samples and for product release

Education, Experience, Knowledge and Skills:

• Bachelor / Master/ PhD degree in Pharmacy, Chemistry, Biology or Pharmaceutical Sciences and 6 / 4 / 2 years relevant industry experience, respectively.
• Experience with Statistics and Design of Experiment (DoE) applied in formulation development as well as product development in an industrial biopharmaceutical environment will be a distinct advantage.
• Extensive experience in CMC development for active pharmaceutical ingredients and drug products under cGMP for Bachelor and Master degree holders.
• Sound knowledge of current Good Manufacturing Practices (cGMP).
• Previous experience with the use of contract facilities is desirable.
• 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.
• Team player with initiative & drive.
• Strong verbal and written communication skills.
• Able to 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 good understanding of the inter-relationship 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 work effectively and efficiently in a team-based environment.
• Critical evaluation of results and ability to defend strategic guidance to resolve technical issues.