Director, GMP Manufacturing

Location
Austin, TX, USA
Posted
Aug 23, 2019
Ref
83647
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 a highly-skilled and highly-motivated professional to lead GMP technical operations and manufacturing facility. This Director will oversee and manage the development, planning, implementation and maintenance of manufacturing methods, processes and operations for plant activities. This position will ensure the effective use of materials, equipment and employees in producing quality products; recommend and author manufacturing policies and procedures; prepare documentation, reports and SOPs as required; and select, train and evaluate personnel to ensure the efficient operation. Also, this position will work closely with Quality teams, external stakeholders and senior leadership to ensure good manufacturing practices guidelines, as well as corporate goals and strategic objectives are met. This requires excellent technical skills and abilities, analytical and mathematical skills, organizational and time-management skills, verbal and written communication skills, plus ability to apply attention to detail.

Job Responsibilities will include:
  • Oversee plant activities, including but not limited to: monitoring processing, maintenance of production equipment and facilities in the manufacturing areas, overseeing documentation of all required production activities, ensure efficiency of materials, and ensuring compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies, and safety practices.
  • Direct operations of production, including but not limited to: scheduling, staffing, training, material use, and troubleshooting to ensure all operations are in full compliance with regulatory and safety guidelines.
  • Partner with Quality to ensure quality requirements, including but not limited to: maintenance of logbook, batch record review, training records and compliance, SOP creation and modification, lead critical level investigations as related to the manufacturing process, approve deviations, non-conformances, and CAPAs, as required.
  • Author and maintain training plans and oversee manufacturing management team.
  • Identify and implement process improvements, particularly for optimization, efficiency and growth
  • Provide leadership related to 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.
  • Coordinate and liaise with collaborators CDMOs to ensure alliance and milestones are met.
  • 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 operational expertise and supervision of plant activities related to biologic production
  • Experience in biopharmaceutical industry, required
  • Proven experience with plant production, required
  • Demonstrated technical proficiency in biologic drug substance processes
  • 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 plant and perform hands-on training, as needed
  • 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 strategic and operational 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