Director, Downstream Development

Location
Austin, TX, USA
Posted
Oct 20, 2019
Ref
83646
Required Education
Masters Degree/MBA
Position Type
Full time
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 lead late-stage Downstream Development and transfer of novel protein-based therapeutics to Manufacturing. This Director will be responsible for design and development of methods for protein purification, scale-up processes and testing of new proteins and technologies. This position will work closely with both the R&D team, Upstream Development and Production to optimize techniques and operations. This entails strategic and operational management of team; protocol development; process improvement; batch record review; scheduling; data analysis and technical report preparation; adherence to laboratory and company policies; assist in training plans and productivity oversight team. 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:
  • Manage design, develop and optimization of protein purification methods while consulting with leadership and external stakeholders. This includes but not limited to: buffer and solution preparation and selection, various filtration methods, centrifugation, chromatography, column packing and packed bed qualification, various sterilization methods, vialing and labeling; maintaining knowledge of scientific trends and industry processes through readings, conferences and seminars; reviewing literature to enhance or improve manufacturing procedures and methods.
  • Lead and conduct technology transfer, process validation activities and development of manufacturing specifications.
  • Analyze data, summarize conclusions and plans for further action, and present results to team members and management in a clear and timely manner.
  • Contribute to technical reports and CMC sections for regulatory filings.
  • Document all procedures and ensure that protocols are up-to-date in an accurate and timely manner.
  • Maintain knowledge of scientific trends industry processes through readings, conferences and seminars; review literature to enhance or improve manufacturing procedures and methods. Use professional concepts and company policies and procedures to solve a wide range of difficult problems in creative and practical ways.
  • Implement complex projects and process development, as needed.


Qualifications:
  • MS degree; or PhD in life sciences, chemical engineering, biochemical engineering or related relevant field
  • Minimum of eight (8) years of experience providing both scientific or operational expertise to protein-based downstream activities
  • 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 thought-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, Manufacturing.

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

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