GMP Supervisor - Downstream
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.
Molecular Templates is seeking a highly-skilled and highly-motivated professional to manage production through downstream 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:
- Manage downstream activities in pilot plant, including but not limited to: assist management with production schedules and priorities, monitor processing, maintain production equipment and facilities in the manufacturing areas, review documentation of materials and batch records, and ensure compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies, and safety practices.
- Provide daily oversight to production and personnel, 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.
- Perform quality requirements, including but not limited to: maintenance of logbook, batch record review, training records and compliance, SOP creation and modification, and author deviation and change requests
- Collaborate with Manufacturing and Process Development teams to improve processes or resolve production concerns.
- Identify and implement process improvements, particularly for optimization, efficiency and growth.
- 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 prtein purification, 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
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.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.