Supervisor, GMP Manufacturing - Downstream (2nd Shift)

Location
Austin, TX, USA
Posted
Oct 07, 2020
Ref
132757
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 currently has several ETB candidates in clinical development including MT-3724 and MT-5111. Additional preclinical compounds derived from our ETB platform technology 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 manage production through upstream activities of investigational medical product in state-of-the-art cGMP manufacturing facility. The GMP Supervisor will primarily manage daily supervision of operating personnel, scheduling and maintenance of manufacturing methods, and effective use of materials and equipment. This position will also work collaboratively with quality and facilities teams. This requires excellent technical skills and abilities, analytical and mathematical skills, organizational and time-management skills, verbal and written communication skills, plus ability to manage competing priorities and projects with ability to function independently and exercise of good judgement.

Job Responsibilities will include:
  • Ensure personnel safety.
  • Promote and maintain best-in-class housekeeping and organizational standards.
  • Provide on-the-floor support to team and production activities.
  • Develop and maintain production schedule for functional team.
  • Ensure Right-First-Time execution on on-time delivery of production plan.
  • Provide feedback and coaching to maximize individual/team performance and development.
  • Hire, on-board, train, develop, and manage performance of staff.
  • Review and approve Batch Record documentation; maintain compliance with production related documentation such as logbooks, equipment calibration, clean room behaviors.
  • Ensure team training compliance to curriculum and enable training and development activities.
  • Analyze process data, operational trends and performance.
  • Initiate action to prevent process and human performance related errors.
  • Communicate with Quality counterparts promoting a partnership in GMP execution.
  • Implement, promote and support creating positive change.
  • Maintain Key Performance Indicator tracking, implement counter measures and actively manage performance to identified goals.
  • Initiate and author SOP changes, perform root cause analysis for human performance related deviations and support risk assessment and change control processes.
  • Collaborate with technical, quality and operational team members to improve processes or resolve production concerns.
  • Identify and implement process improvements, particularly for optimization, efficiency and growth.


Qualifications:
  • Bachelor's degree or equivalent in related field
  • Minimum of five (5) years of related professional experience of manufacturing under GMP regulatory requirements.
  • Minimum of two (2) years of supervisory experience
  • Demonstrated experience and comprehensive knowledge of downstream processing activities, specifically chromatography, tangential flow filtration, bulk drug substance fill, required
  • Experience in biopharmaceutical industry, preferred
  • Comprehensive and demonstrated knowledge of laboratory equipment, product use, and terminology
  • Excellent problem-solving and analytical skills
  • Excellent project management, time management, and multi-tasking skills
  • Excellent written and verbal communication skills
  • Excellent computer skills with knowledge of spreadsheet, word processing and statistical analysis software
  • Ability to manage competing priorities or projects
  • Ability to function independently and exercise good judgement
  • Ability to identify problems and solutions then take action to resolve
  • Demonstrated ability to resolve technical and operational issues
  • Ability to understand instructions and to learn how to maintain equipment
  • Ability to apply attention to detail as applied to data review and compliance
  • High degree of reliability and professionalism
  • Ability to work in a fast-paced, high-growth team environment
  • Ability to lift 30 lbs. and must be able to stand, crouch, sit, bend, or stretch for extended periods of time
  • Must possess flexibility to work varying schedules to support operations, such as occasional 12-hour shift or night shift


Reporting Structure:

This position will have supervisory responsibilities. This position reports to Sr. Manager, GMP Manufacturing.

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

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