Formulation Manager, Process Development

Company Description:

Molecular Templates (MTEM) is a clinical stage biopharmaceutical company targeting a variety of cancers through development of its innovative proprietary Engineered Toxin Body (ETB) platform. MTEM's first immunotoxin, MT-3724, is in clinical development for non-Hodgkin's lymphoma. Pipeline products for additional oncology targets are being advanced toward clinical development. For more information, please visit MTEM's website at www.mtem.com.

Position Overview:

Molecular Templates is seeking a highly-skilled and highly-motivated professional to support optimization and transfer of novel protein-based therapeutics to manufacturing activities. The Formulation Manager will be responsible for formulation development for new and existing products, stability studies designing and execution, data analysis, compatibility studies for clinical application, reports and document preparation for regulatory submission and technology transfer to other Manufacturing Departments. This position will require excellent technical, analytical and problem-solving skills, along with ability to operate independently on progressively more complex activities and projects.

Job Responsibilities will include:

• Analyze products' biochemical property to design formulation screening protocol that includes but not limited to buffers, excipients and pH under liquid formulation
• Design, develop and perform short-term stability studies for defined formulation under regular and accelerated conditions
• Understand manufacturing protocol to apply formulation design for in-process sample stability
• Design analytical protocol to evaluate product stabilities under each testing conditions
• Analyze experimental results to define stability and formulation
• Design, develop and perform clinical in-use compatibility studies for IV applications
• Maintain knowledge of scientific trends and industry processes through readings, conferences and seminars; review literature to enhance or improve study procedures and methods. Use professional concepts and company policies and procedures to solve a wide range of difficult problems in creative and practical ways
• Participate in the development of patent applications, regulatory documentation and clinical documentation (for example, Pharmacy Manual)
• Other duties and special projects, as assigned

Qualifications:

• Advanced Degree in Life Sciences, chemical engineering, biochemical engineering or related relevant field
• Minimum of five (5) years of relevant industry experience
• Demonstrated technical proficiency in biologic drug substance and drug product formulation
• Proven experience with protein chemistry and formulation development required
• Excellent written and verbal communication skills
• Excellent computer skills
• Excellent analytical skills and problem-solving skills
• Excellent organizational, time management, and multi-tasking skills
• Ability to maintain highest standards of accuracy and attention to detail
• Ability to function independently and exercise good judgement, as well as provide thought leadership
• Ability to identify problems and solutions then act to resolve

Reporting Structure:

This position currently has no supervisory responsibilities. This position reports to Sr. Director, Process Development.

Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.

Molecular Templates Inc https://mtem.isolvedhire.com