Director, Biopharmaceutical Downstream Purification Process Development

Company Description:

Molecular Templates is a clinical stage biopharmaceutical company focused on the discovery and development of differentiated, targeted, biologic therapeutics for cancer. We believe our proprietary biologic drug platform technology, referred to as engineered toxin bodies, or ETBs, provides a differentiated mechanism of action that may address some of the limitations associated with currently available cancer therapeutics. ETBs utilize a genetically engineered form of Shiga-like Toxin A subunit, or SLTA, a ribosome inactivating bacterial protein, that can be targeted to specifically destroy cancer cells. Additional information about Molecular Templates can be obtained at www.mtem.com.

Position Overview:

Molecular Templates is seeking an experienced and highly-skilled professional to join the Process Development department as Director of Downstream Purification Process Development. This position will lead the development of purification processes for harvested E. coli produced engineered biologic therapeutics. The downstream purification bioprocesses are used for pre-clinical production at pilot plant scale, then scaled up and transferred to GMP manufacturing for clinical trial materials production in Molecular Templates manufacturing facility or at contract manufacturing facility. The Director will be responsible for design, development and scale up of the protein purification steps leading to delivery of bulk drug substance. The Director will lead assessment and introduction of new protein purification technologies. This position will work closely with the R&D, Upstream Fermentation Process Development and Manufacturing teams to optimize downstream purification steps suitable for Manufacturing Operations. The Director will work closely with Molecular Templates Manufacturing Sciences and Process Sciences Teams to prepare Downstream process descriptions and batch records for technology transfer to Manufacturing Operations. This position will require excellent technical, analytical, and problem-solving skills, leadership skills and ability to work in a fast-paced environment.

Job Responsibilities will include:

• Manage design, development, and optimization of protein purification steps suitable for pilot plant production and scale up for GMP manufacturing
• Lead and conduct process optimization, process characterization, technology transfer, process scale-up for clinical production and eventual full-scale commercial production
• Define strategy and plans for downstream purification leading to high quality drug substance with targeted CQAs
• Prepare technical reports and CMC sections for regulatory filings.
• Prepare downstream process descriptions, protocols for purification at small-scale and scale-up for GMP production.
• Introduce new purification technologies into downstream process to improve quality, yield and ease of operations in manufacturing.
• Lead downstream tech transfers to CDMOs and ensure downstream is executed successfully and delivers clinical grade batches of drug substances
• Serve as subject matter expert for downstream process development at Molecular Templates
• Lead team of downstream purification scientists to execute development studies leading to well designed, operationally executable purification steps for drug substance production
• Define critical process parameters and acceptable operating ranges for downstream process steps
• Establish in-process controls to ensure target performance of each downstream purification step to deliver drug substance meeting release specifications
• Train and develop staff to become proficient in downstream process development, process characterization and tech transfer
• Provide status updates on downstream development progress on projects to cross-functional teams and management forums
• Serve as a member of the Process Development leadership team

Qualifications:

• PhD in life sciences, chemical engineering, biochemical engineering or related relevant field
• Minimum of eight (8) years experience providing both scientific or operational expertise for downstream process development
• Minimum of two (2) years supervising direct reports
• Experience in biopharmaceutical industry, required
• Proven experience with developing and designing downstream processes, required
• Demonstrated technical proficiency in biologic drug substance processes with expertise in downstream purification operations, such as centrifugation, filtration, UF/DF, chromatography, and buffer formulation
• Excellent problem solving and analytical skills
• Excellent project management, time management and multi-tasking skills
• Excellent written and verbal communication skills
• Excellent computer skills
• Ability and willingness to work in the laboratory and perform hands-on training
• Ability to maintain highest standards of accuracy and attention to detail
• Ability to manage multiple projects and competing deadlines
• Ability to function independently, exercise good judgement and provide thoughtful leadership
• Ability to work in a fast-paced, high-growth, and team-based environment
• Ability to identify problems and solutions, then take action to resolve

Reporting Structure:

This position has supervisory responsibilities. This position reports to Vice President, Process Development.

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

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