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Process Development Scientist

Company: Actym Therapeutics, Inc.
Location: Berkeley
Posted on: January 12, 2022

Job Description:

Actym Therapeutics, Inc. is a Berkeley, CA based venture-backed biotechnology company focused on developing novel immunotherapies intended to transform the treatment of cancer. - -Patients burdened with metastatic disease desperately need new and effective treatment options. - -Actym's revolutionary microbial-based technology platform is designed to overcome the hostile tumor microenvironment and promote durable anti-tumor immunity. This technology allows for the safe, programmed delivery of multiplexed immunological payloads to tumor-resident immune cells after IV dosing, in a single therapeutic composition. This paves the way for safely targeting immunological pathways that are intractable using conventional small molecule or antibody-based therapeutics due to systemic toxicities, which are of significant interest to the biopharma community. -Actym recently completed a significant venture financing and is backed by top tier investors.

Our people are our greatest asset. They bring scientific talents in microbiology, process development, molecular biology, cancer immunology, genomic engineering, and pharmacology to make the future happen now.

Position Summary

Actym Therapeutics is a rapidly-growing company seeking a talented individual to join our CMC Development Team. As a Process Development Scientist I/II, you will report directly to the Process Development Lead and will be based in our Berkeley R&D facility.

Essential Duties And Responsibilities

Routine fermentation of wild-type and engineered Salmonell a strains to support CMC Development activities.
Experimental evaluation and optimization of fermentation conditions, medium formulations, and process parameters in shake flasks and bench-scale fermentors.
Development and optimization of downstream process conditions and operating parameters at bench scale, with emphasis on TFF-based technologies.
Experimental evaluation of STACT product formulations that provide enhanced product activity and stability.
Performance of microbiological assays for enumeration and characterization of STACT preparations (viable plate counts, microscopic cell counts, live/dead cell staining, specialized characterization methods to confirm engineered strain properties)
Support transfer of STACT upstream and downstream production processes to contract manufacturers. This includes writing and reviewing Actym CMC Development procedures, experimental protocols, draft manufacturing Master Batch Records, etc. Transfer activities may include onsite support at contract manufacturing facilities for demonstration of process operations, training of personnel and/or serving as Person-In-Plant (PIP) during non-GMP and GMP manufacturing runs.
Provide technical support to Quality for review and release of GMP batch documentation.
Provide expert technical input for review of business documents, including CDMO project proposals, MSAs, Quality Agreements, etc.
Provide general lab support and management
Communicate project updates and technical reports to supervisor and senior level management.
Identify and promptly troubleshoot technical issues.
Keen in learning new methods and technique.
Flexibility to multi-task across numerous scientific disciplines.
Familiarity with cell culture techniques for mammalian cells, insect cells and E. c oli a plus.

The incumbent will be responsible for assisting in the development of upstream and downstream process parameters to support manufacturing of Actym's clinical development candidates. The employee will be responsible for general lab support, executing projects within the laboratory, writing study/development plans and protocols, and summarizing data to clients and colleagues via technical reports. As a Scientist I/II, you may have one or more associates/associate scientists reporting to you.

Requirements

We are seeking a motivated Process Development Scientist with experience in process development for manufacturing of biotherapeutics. The position requires a drive to provide outstanding customer service by maintaining regular and effective communications with internal colleagues and external contractors as well as meeting or exceeding quality and timeline expectations.

PhD (1-2 years industry experience), MS (3-4 years industry experience) or BS (5+ years industry experience) in Microbiology, Biochemistry, Biotechnology, or Biochemical Engineering.
Hands-on experience with microbial fermentation and downstream processing technologies (especially Tangential Flow Filtration) is required.
Experience with performance of routine microbiological analyses to support process development is highly preferred.
Prior experience working with Contract Development and Manufacturing Organizations (CDMOs), including manufacturing process transfer and PIP experience for manufacturing runs, is a plus
Prior experience working in a cGMP regulated environment for pharmaceutical biologics development and/or manufacturing is a plus.
Prior experience working with Live Microbial Products (bacterial or viral) is a plus.
Good organizational and documentation skills and the ability to work independently in a fast-paced work environment are required.

Must be able to clearly and accurately present written data and be comfortable with oral presentations.
Independent, collaborative, team player.
Excellent multi-tasking abilities and exceptional attention to details are required.
Occasional travel to CDMO facilities to support contractor evaluations, process transfer, or PIP activities may be required.

Work Environment
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Work is performed in an office and laboratory environment. May be exposed to biological and chemical hazards. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. Light to moderate lifting and carrying objects with a maximum lift of 30lbs. Must be able to work while wearing personal protective equipment such as safety glasses, gloves, and lab coats deemed necessary to protect testing and to protect employees. Work is to be performed on site.

Disclaimer This job description is not necessarily a comprehensive list of all duties and responsibilities. The employer reserves the right to revise key functions of this position at any time. Actym is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Keywords: Actym Therapeutics, Inc., Berkeley , Process Development Scientist, Other , Berkeley, California

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