Manager / Sr. Manager, Manufacturing Operations

Location
Austin, TX, USA
Posted
Oct 03, 2020
Ref
190108
Required Education
Bachelors Degree
Position Type
Full time
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 lead GMP manufacturing operations. The Manager / Sr. Manager, Manufacturing Operations 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 efficient operations. This position will work closely with quality, engineering, and supply chain teams as well as with internal/external stakeholders and senior leadership to ensure good manufacturing practices and guidelines as well as corporate goals and strategic objectives are met. This position 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:
  • Manage and direct daily GMP operations including but not limited to scheduling, staffing, training, material use, and on-the-floor support and troubleshooting for production activities.
  • Provides hands-on supervision of manufacturing staff in the operation of pharmaceutical manufacturing equipment including but not limited to incubators, single-use fermenters, microfluidizers, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment.
  • Maintain Key Performance Indicator tracking and actively manage progress towards operational and strategic goals.
  • Plan, schedule, and support medium- and long-term production tasks and ensure schedule adherence.
  • Ensure Right-First-Time execution and on-time delivery of the production plan.
  • Provide oversight for all required documentation needed production activities.
  • Provide oversight for the review of manufacturing SOPs, batch documentation and logbooks as well as initiation of deviations, CAPAs and change controls.
  • Ensure timely corrections to batch documentation and logbooks.
  • Ensure compliance with current corporate policies, regulatory guidelines, and safety practices.
  • Ensure equipment and manufacturing facility remain in working order and ensure timely submission of work orders for facility and equipment maintenance and repair.
  • Initiate action to prevent process and human performance related errors.
  • Identify and implement process improvements, particularly for optimization, efficiency, and collaborate with technical, quality, and operational team members to improve processes or resolve production concerns.
  • Recruit, hire, on-board, train, and develop a high-preforming team. Provide supervision and complete evaluations for individual/team performance and development of direct reports.
  • Actively participate in an environment which fosters safety, quality, and continuous improvement.

Qualifications:
  • Bachelor's in the biological sciences, chemical/biochemical engineering, or related field with 7+ years relevant experience (Manager Level) or 10+ years relevant experience (Sr. Manager Level).
  • Bachelor's in related field with (15+) years relevant experience will be considered.
  • 5+ years of experience managing others, required.
  • Extensive experience working in a cGMP environment, required.
  • Extensive experience with fermentation and/or purification processes, required.
  • Extensive knowledge of biopharmaceutical manufacturing processes and equipment, required.
  • Extensive knowledge of SOPs, cGMPs, safety principles, regulatory guidelines, and quality systems, required.
  • Supervisory and or leadership experience which demonstrates proficiency in selection of team and effectively managing personnel issues highly desired.
  • Adaptable to a fast paced, complex, and ever-changing business environment.
  • Effective communication and technical writing skills with support groups in the coordinating system to obtain needed cooperation and support as required in a timely and effectively manner.
  • Ability to work independently, prioritize and manage time efficiently with strong problem solving and analytical skills.
  • Highly motivated and proactive with a track record of taking initiative to achieve business results.
  • Ability to identify problems and take action to resolve them.
  • Strong oral and written communication skills.
  • Excellent organization skills.


Reporting Structure:

This position has supervisory responsibilities. This position reports to Director, Manufacturing.

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

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