Team Lead, Manufacturing - GMP Downstream (1st Shift)

Location
Austin, TX, USA
Posted
Nov 04, 2020
Ref
190806
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 an energetic and highly motivated professional to support downstream processing of therapeutic proteins. This position will execute protein purification unit operations within GMP manufacturing. The Team Lead ensures the effective use of materials, equipment, employed in producing quality products; recommends and authors manufacturing policies and procedures; and prepares documentation, reports, and SOPs as required. This position will provide on-the-floor execution and leadership support to bioprocessing unit operations. The Team Lead will be responsible for adhering to Standard Operating Procedure (SOP) guidelines, Good Manufacturing Practices and all safety requirements in a multi-product GMP manufacturing facility. 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:
  • Perform protein purification for downstream manufacturing activities
  • Document and verify production steps in accordance with manufacturing instructions
  • Develop and adhere to production schedules and timelines
  • Work cross-functionally to achieve team goals
  • Partner with Quality Assurance personnel to deliver quality product
  • Provide direction and coaching to team members during bioprocessing manufacturing
  • Communicate status, actions, and drive improvement on key performance indicators
  • Ensure safety, compliance and Right-First-Time execution
  • Support room and equipment preparation for manufacturing operations
  • Maintain readiness of materials, rooms and equipment for operations
  • 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
  • Identify and implement process improvements, particularly for optimization, efficiency, and growth
  • Collaborate with technical, quality, and operational team members to improve processes or resolve production concerns
  • Actively participate in an environment which fosters safety, quality, and continuous improvement

Qualifications:
  • Bachelor's degree with 5+ years relevant experience; A.S. with 8+ years relevant experience will be considered.
  • Experience working in a GMP manufacturing environment with purification processes, required
  • Experience with Chromatography, Ultrafiltration/Diafiltration, Bulk Fill and Column Packing, required
  • Knowledge of biopharmaceutical manufacturing processes and equipment, required
  • Knowledge of SOPs, cGMPs, safety principles, regulatory guidelines, and quality systems, required
  • 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 in a timely and effective 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 meet deadlines and maintain production schedule
  • Ability to identify problems and take action to resolve them
  • Ability to follow written and verbal instruction and work under supervision
  • Strong oral and written communication skills
  • Ability to lift up to 40lb loads multiple times per shift and carry up to 30 lbs; Must be able to stand, crouch, sit, bend, or stretch for extended periods of time


Reporting Structure:

This position does not have supervisory responsibilities. This position reports to Manufacturing Operations Supervisor, Downstream.

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

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