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Downstream Process Development Manager Jobs in California

Debut Biotech

Staff Process Engineer

San Diego, CA · On-site

Staff Process Engineer Summary The Staff Process Engineer, Downstream Processing (DSP) will take a leading role in the strategy, development, and execution of downstream purification processes for ...

Debut Biotech

Staff Process Engineer

San Diego, CA · On-site

Staff Process Engineer Summary The Staff Process Engineer, Downstream Processing (DSP) will take a leading role in the strategy, development, and execution of downstream purification processes for ...

BioTalent

Laboratory Technician

Tustin, CA · On-site

$19.61 - $24.51/hr

🚀 Laboratory Technician, Process Development Downstream 📍 Tustin, CA | On-site 🗓 Monday-Friday | Nighshifts 🌱 Support the Development of Life-Saving Biopharmaceuticals 🎓 Great ...

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Downstream Process Development Manager information

What is a downstream process development manager?

A Downstream Process Development Manager is a professional responsible for overseeing the development and optimization of downstream processes in biomanufacturing, particularly the purification and recovery of biological products after fermentation or cell culture. They lead teams in designing, scaling up, and validating processes such as filtration and chromatography to ensure product quality and regulatory compliance. These managers collaborate with cross-functional teams, manage timelines, and troubleshoot technical challenges to streamline production. Their role is critical in ensuring the efficiency and safety of biologic drug manufacturing.

What are the key skills and qualifications needed to thrive as a downstream process development manager, and why are they important?

To thrive as a Downstream Process Development Manager, you need a solid background in biochemistry, chemical engineering, or a related field, often with an advanced degree and industry experience in bioprocessing. Expertise in chromatography systems, filtration technologies, and statistical process control tools, along with familiarity with GMP regulations, is critical. Strong leadership, project management, and cross-functional communication skills help drive innovation and team performance. These competencies ensure efficient process development, regulatory compliance, and successful scale-up of biomanufacturing operations.

What are common challenges faced by downstream process development managers, and how can they be addressed?

Downstream Process Development Managers often encounter challenges such as optimizing purification processes for yield and purity, scaling up from lab to production, and troubleshooting process deviations. Addressing these issues requires strong collaboration with upstream teams, analytical departments, and manufacturing. Staying current with emerging technologies, maintaining robust documentation, and fostering a culture of continuous improvement are key to successfully overcoming these hurdles and ensuring efficient process transfer to manufacturing.

What are the most commonly searched types of Downstream Process Development jobs in California?

The most popular types of Downstream Process Development jobs in California are:

What cities in California are hiring for Downstream Process Development Manager jobs?

Cities in California with the most Downstream Process Development Manager job openings:

Associate Scientist, Process Development Downstream

Tustin, CA • On-site

Avid Bioservices
Pharmaceutical and Medicine Manufacturing • 51 - 200 employees
Learn more about Avid Bioservicesexternal

$94K - $118K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 15 days ago

Key responsibilities

  • Design, optimize, and transfer downstream processes for monoclonal antibody development programs.

  • Perform experiments at the bench scale to support process development, characterization, and process improvements.

  • Communicate experimental results through oral presentations and technical documentation to support regulatory filings.

Job description

Description
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
Within Process Development, the Associate Scientist, Process Development - Downstream in the Purification Process Development lab will design, optimize scales and transfer downstream processes for mAb development programs.
Key Responsibilities:
  • Applies established platform approaches and utilizes problem-solving skills to rapidly solve day- to day experimental challenges.
  • Performs experiments at the bench scale, spanning the end-to-end downstream drug substance process.
  • Applies fundamental scientific and engineering principles to purification processes to support process development and process characterization, evaluate process improvements and resolve potential processing issues.
  • Designs suitable experiments and analyzes results to draw meaningful conclusions.
  • Communicates work through oral presentations and written documentation including technical reports and GMP documents to support regulatory filings.
  • Participate with cross-functional teams and interact with representatives from Process Development, Project Management, Manufacturing, and Quality to arrive at and implement viable/practical solutions to support clinical/commercial manufacturing.
  • Provides scientific technical support for technology transfer of processes to manufacturing.
  • Demonstrates the desire to expand and develop skills in purification.
  • Utilizes out-of-the-box thinking to contribute to technology development.
  • Familiarity with design of experiments and statistical analysis of data.
  • May be the primary project contact with a client and must be able to articulate the science and problem solving.
  • May supervise laboratory assistants or research associates but primarily would be an individual contributor.
  • Other duties may be assigned.

Minimum Qualifications:
  • PhD degree, with preferred 2 years of process development and/or similar experience or:
  • Master's degree and minimum 2 years; with preferred 4 years of process development and/or similar experience or:
  • Bachelor's degree and minimum of 4 years; preferred 6 years of process development and/or similar experience.

Preferred Qualifications:
  • Process development experience.

Position Type/Expected Hours of Work:
This role is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5 p.m. unless otherwise stated by Supervisor. The employee must also, if instructed, have the ability to work overtime and/or weekends when necessary.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $94,400 - $118,000 annually, depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
  • You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
  • Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
  • You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
  • You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.

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