(Principal) Senior Scientist, Purification Process Development
Molecular Templates is seeking a highly skilled and motivated professional to support downstream process development. The Principal or Senior Scientist will be responsible for developing robust, efficient, and scalable downstream processes for the manufacture of recombinant biologics. This includes experimental design, execution, analysis, and report authoring of process development activities like cell lysis, various clarification methods, filtration, chromatography, ultrafiltration, diafiltration, formulation and vialing.
This position may be responsible for leading a team or project team and will be responsible for delegating activities and ensuring the team's proper execution of experiments. Additional activities will include solution preparation, equipment maintenance and calibration, data management, report authoring, review of manufacturing processes and identification of continuous process improvement opportunities. This includes new product scale-up, purification, process optimization, technology transfer and process validation activities, as well as developing production procedures and product specifications. This position will require excellent technical, analytical and problem-solving skills, along with ability to operate independently and lead a small team on progressively more complex activities and projects.
- May include leadership of a small team or project team in downstream development activities
- Independently develop downstream processes for biologic manufacturing activities. This includes, but is not limited to buffer and solution preparation, cell lysis, various filtration methods, centrifugation, chromatography, column packing and packed bed qualification, various sterilization methods, vialing and labeling, and process data recording and trending.
- Capable of progressing multiple activities in parallel
- Work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
- Exercise judgment in selecting methods, techniques and evaluation criteria for obtaining results
- Network with key contacts outside own area of expertise
- Conduct limited characterization of protein products, impurities, and protein purification using common laboratory techniques
- Maintain detailed experimental records. Complete required documentation in an accurate and timely manner, adhering to written procedures and regulatory requirements.
- Review and revise established protocols and SOPs related to drug development, such as process development and optimization techniques. This may also include developing and optimizing assays, conducting limited literature search of research study protocols and reports, regulatory documents, and other potential resources.
- Conduct general laboratory duties, including washing glassware, ordering supplies, and maintaining inventory e.g. buffer and basic laboratory equipment
- Assist with non-complex projects, such as laboratory sanitization and organization or implementation of new instrumentation, as needed
- Support technology transfer of downstream process internally and externally
- Occasional preclinical manufacture (lab scale) of biologics for formulation, characterization, etc.
- Support downstream manufacturing investigations through scale-down studies and experimental investigations
- Author execution plans, technical reports, process descriptions, and risk assessments for internal and external review
- Maintain knowledge of scientific and industry trends
- Degree in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry field or similar field of study, advanced degree, preferred.
- Degree plus minimum years of relevant industry experience: BS + thirteen (13) years, or MS + nine (9) years, or PhD + four (4) years
- Demonstrated proficiency in downstream processing activities/protein purification, required
- Experience in biopharmaceutical industry, required
- Experience in developing and designing downstream processes, required
- Proficiency with Akta and Unicorn programming, required
- Experience leading a project, preferred
- Previous experience overseeing the work of others, preferred
- Experience with statistical, multivariate analysis and JMP software, preferred
- Excellent written and verbal communication skills
- Excellent computer skills with knowledge of spreadsheet and word processing
- Excellent problem-solving and analytical skills applied to investigations
- Excellent organizational, time-management and multi-tasking skills
- Ability to maintain high standards of accuracy and attention to detail
- Ability to follow written and verbal instruction and work under supervision
- Ability to work in a fast-paced, 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 may have indirect or direct supervisory responsibilities. This position reports to the Leader of Downstream Process Development.
Molecular Templates celebrates and supports our differences and is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, veteran status, disability, or any other legally protected characteristic.
MTEM is committed to providing reasonable accommodations for qualified individuals. If you need assistance with your application due to a disability, you may contact us at: email@example.com.
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