Manufacturing Associate - GMP Downstream

Location
78729, Austin
Posted
Sep 19, 2018
Ref
38532
Required Education
High School or equivalent
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 experienced and highly-motivated professional to support downstream processing for production activities. This position will perform functions related to production and GMP manufacturing operations, including routine protein purification, including optimization and formulation, equipment maintenance checks and calibration, buffer and solution preparation, and finished product activities, such as printing, labeling and filling. This position will also be responsible for general facility and equipment preventative maintenance and sanitization. This will require excellent technical skills and strict adherence to Standard Operating Procedure (SOP) guidelines and verbal instructions and accurate and timely completion of manufacturing batch records.

 

Job Responsibilities will include:

  • Perform protein purification for downstream manufacturing activities. This includes, but not limited to: buffer and solution preparation, various filtration methods, centrifugation, chromatography, column packing and packed bed qualification, various sterilization methods, vialing and labeling, process data recording and trending.
  • Conduct limited characterization of protein products, impurities, and protein purification using common laboratory techniques.
  • Complete required documentation in an accurate and timely manner, strictly adhering to established SOPs and regulatory requirements.
  • Adhere to production schedules and timelines
  • Ensure highest degree of personal safety and facility security throughout operations
  • Conduct general laboratory and equipment maintenance duties, including washing glassware, ordering raw materials, products and other resources, and maintaining inventory (e.g. buffer), conducting preventative and safety checks on facility and equipment
  • Assist with non-complex projects, such as facility sanitization and organization, implementation of new instrumentation or proposal of technical improvements, as needed

 

Qualifications:

  • High school diploma or equivalent with college science coursework, required; or Associates degree or Bachelor's degree in life science, chemistry, pharmaceutical science or related field, preferred
  • Minimum of two (2) years relevant experience in GMP manufacturing environment or laboratory conducting or supporting protein purification methods
  • Experience in biopharmaceutical industry, preferred
  • Demonstrated experience and comprehensive knowledge of downstream processing activities, specifically protein purification, required
  • General knowledge of compliance with internal and external safety, quality, and regulatory standards in accordance with 21 CFR Part 211
  • Excellent written and verbal communication skills
  • Proficient computer skills with knowledge of spreadsheet and word processing
  • Excellent problem-solving and analytical skills
  • Excellent organizational, time management and multi-tasking skills
  • Ability to meet deadlines and maintain production schedule
  • Ability to follow written and verbal instruction and work under supervision
  • Ability to understand and exercise basic mathematical calculations
  • Ability to work in a fast-paced, high-growth team environment
  • Ability to lift 75 lbs. manually or with additional assistance from staff and/or mechanical lifting equipment (e.g. dolly, cart, lift, hand truck, etc.). 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 has no supervisory responsibilities. This position reports to GMP Supervisor.

 

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.

https://mtem.isolvedhire.com/jobs/38532-19034.html