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Associate Downstream Process Development Scientist Jobs in California

Development Scientist

San Diego, CA · On-site

$80K - $120K/yr

SkylineDx USA is seeking a Development Scientist to support process development and assay support activities for our CLIA‑certified laboratory. This role plays a key part in assay development ...

Work closely with senior scientists and engineers to implement process improvements. Support ... culture) and downstream (purification)operations; 2. Experience with mammalian cell culture ...

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Associate Downstream Process Development Scientist information

What is an Associate Downstream Process Development Scientist?

An Associate Downstream Process Development Scientist is a professional who works in the biotechnology or pharmaceutical industry, focusing on developing and optimizing processes that purify biological products, such as proteins or antibodies, after they have been produced by cells. Their work is crucial for ensuring the final product meets quality and safety standards before it is used in research or clinical applications. They typically perform laboratory experiments, analyze data, and collaborate with other scientists and engineers to improve yield and efficiency. This role is often entry-level or early-career, providing hands-on experience in process development and technical troubleshooting.

What are the key skills and qualifications needed to thrive as an Associate Downstream Process Development Scientist, and why are they important?

To excel as an Associate Downstream Process Development Scientist, you need a solid understanding of biochemistry, chemical engineering, and downstream purification techniques, often supported by a bachelor's or master's degree in a life science or engineering discipline. Familiarity with chromatographic systems (such as AKTA), filtration equipment, and analytical tools, as well as knowledge of GMP/GLP regulations, is typically required. Strong problem-solving, attention to detail, and effective teamwork and communication skills help you navigate complex experiments and collaborate with cross-functional teams. These skills ensure efficient process optimization, compliance with regulatory standards, and successful development of biopharmaceutical products.

What is the difference between Associate Downstream Process Development Scientist vs Associate Upstream Process Development Scientist?

AspectAssociate Downstream Process Development ScientistAssociate Upstream Process Development Scientist
Primary FocusPurification and recovery of bioproductsCell culture and fermentation processes
Required SkillsProtein purification, chromatography, filtrationCell culture, bioreactor operation, media preparation
Work EnvironmentLaboratories, manufacturing facilitiesLaboratories, bioreactor labs
Common CertificationsBiotech or bioprocessing certificationsBiotech or bioprocessing certifications

Both roles are essential in biopharmaceutical development, focusing on different stages of the production process. The Associate Downstream Process Development Scientist specializes in purification techniques, while the Associate Upstream Process Development Scientist concentrates on cell growth and fermentation. Understanding these distinctions helps candidates target their skills and career paths effectively.

What are some typical challenges faced by an Associate Downstream Process Development Scientist, and how can they be addressed?

Associate Downstream Process Development Scientists often encounter challenges such as optimizing purification processes, troubleshooting equipment performance, and ensuring batch-to-batch consistency. These challenges can be addressed by maintaining meticulous documentation, collaborating closely with upstream and analytical teams, and staying current with best practices in chromatography and filtration. Proactively seeking feedback from experienced colleagues and participating in cross-functional meetings can also help in identifying solutions and improving process efficiency.
What are the most commonly searched types of Downstream Process Development Scientist jobs in California? The most popular types of Downstream Process Development Scientist jobs in California are:
What cities in California are hiring for Associate Downstream Process Development Scientist jobs? Cities in California with the most Associate Downstream Process Development Scientist job openings:

Senior Scientist I, Process Development

LGC Group

Petaluma, CA • On-site

$104K - $142K/yr

Full-time

Posted 9 days ago


Job description

Company Description
Axolabs is a business unit of LGC, and a leading provider of CRO / CDMO capability to the therapeutic oligonucleotide discovery and development industry. Centred out of LGC's site in Kulmbach, Germany, Axolabs works closely with its customers to assist the identification and development of lead candidates with a broad suite of bioinformatics, biology, chemistry, manufacturing and analytical services that support discovery, pre-clinical and clinical trials and scale-up manufacture. With a track record in Nucleic Acid Therapeutics that traces back more than 20 years, Axolabs provides deep knowledge and expertise in the services it provides, working collaboratively and responsively with its clients to assist them in achieving their objectives.
Axolabs facility in Petaluma is focused on manufacturing scale-up and production to cGMP of multigram to kilograms of API for pre-clinical and clinical development. Our site in California has been involved in oligonucleotide synthesis for three decades and established the therapeutics activity in 2019. With around 70 staff and two manufacturing trains, Axolabs offers a flexible manufacturing service out of Petaluma that draws where necessary on our industry and chemical and analytical expertise in Kulmbach.
Job Description
Position Summary:
The Senior Scientist in LGC Axolabs Process Development will serve as a subject matter expert (SME) in scale up/down solid-phase oligonucleotide synthesis, purification, concentration, conjugation, and downstream processing steps in preparation for handover to routine manufacturing.
This role involves leading process development initiatives, providing technical guidance to cross-functional teams, and engaging with clients to ensure successful and timely execution of each assigned program.
LGC Axolabs has an extensive, ever-evolving global client base along with impressive technical capabilities within a state-of-the-art GMP facility. As the needs for the organization continue to grow, we are seeking technically adept and highly motivated candidates who can contribute to innovative solutions in oligonucleotide process development. The successful candidate will be detail-oriented, proficient in advanced chemistry techniques, and experienced in oligonucleotide manufacturing. This role requires strong problem-solving skills, technical leadership, and direct interaction with clients to support their project needs.
Areas of Responsibility:
Routine tasks include leading process development of all unit operations of custom oligonucleotide manufacturing including but not limited to: solid phase synthesis, cleavage and deprotection, preparative HPLC purification, conjugation chemistry, ultrafiltration/diafiltration, and lyophilization according to established project timelines. Also included will be sample preparation of samples to the Analytical Development Team and technical support provided to the manufacturing team for relevant programs.
To perform this job successfully, an individual must be able to perform each essential function satisfactorily.
Essential Functions:
  • Serve as a subject matter expert (SME) in process development of oligonucleotide APIs, including research and implementation of novel techniques.
  • Independently design, execute, and interpret complex experiments, including use of DoE techniques.
  • Lead technical discussions with internal teams and clients to define development strategies, troubleshoot challenges, and drive project deliverables.
  • Author and review technical documentation, including client updates, project plans, QPPs, TDRs, and SOPs.
  • Collaborate with cross-functional teams (e.g., Analytical Development, Quality Control, and Manufacturing) to integrate development solutions into oligonucleotide production workflows.
  • Maintain working knowledge of relevant regulatory and pharmacopeia guidelines (FDA/ICH/USP) to ensure compliance across tech transfer activities.
  • Provide mentorship and technical guidance to junior scientists, supporting skill development and scientific excellence within the team.

Shift hours: Monday through Thursday, 8:00 a.m. to 6:00 p.m. PT
Qualifications
Minimum Qualifications:
  • Bachelor's degree in Chemistry, Biology, Biochemistry, or related discipline with 7+ years of applicable experience, or Master's degree with 5+ years, or Ph.D. with 0-3 years of experience in a related field.
  • Advanced technical understanding of oligonucleotide manufacturing processes and hands-on experience with relevant chemistry techniques, equipment, and methods.
  • Strong communication skills, both written and verbal, to effectively collaborate with internal cross-functional teams and external partners
  • Demonstrated dedication to scientific excellence and alignment with LGC's core values and quality standards
  • Proficiency in Microsoft Office, Outlook, Word, Filemaker Pro, IFS, and Excel
  • Self-starter with strong problem-solving skills and the ability to work independently and with the broader team
  • Ability to manage multiple development projects simultaneously while maintaining attention to detail and deliverable timelines.
  • Demonstrated commitment to scientific excellence and alignment with LGC's core values and quality standards.

Preferred Qualifications:
  • Technical understanding of oligonucleotide manufacturing processes and hands-on experience with relevant chemistry techniques, equipment, and methods
  • Working knowledge of ChemDraw and Unicorn software (Synthesis and Purification)
  • Prior experience in a GMP-regulated environment within a CMO/CDMO or pharmaceutical manufacturing setting

Physical Requirements:
The physical requirements outlined here reflect those that an employee must satisfy to effectively carry out the essential duties of this position. Reasonable accommodations can be provided to assist individuals with disabilities in performing these essential duties.
Additional Information
The typical pay range for this role is:
Minimum: $93,750 USD per year
Maximum: $156,250 USD per year
This range represents the low and high end of the anticipated salary range for the California-based position. The actual base salary will depend on several factors such as experience, skills, and location.
About LGC:
LGC is a major international life sciences tools company, delivering key components and solutions to fast-growing application areas in human healthcare and applied market segments. Our high-quality product portfolio features important tools for genomic analysis and quality assurance applications, appreciated for their performance, quality, and scope.
Our values
  • PASSION
  • CURIOSITY
  • INTEGRITY
  • BRILLIANCE
  • RESPECT

Equal opportunities
At LGC, we hold the conviction that every applicant and employee should be appreciated for their distinct skills, regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or parental leave, religion, or belief. Shortlisting, interviewing, and selection procedures are consistently performed without bias toward gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership.
For more information about LGC, please visit our website www.lgcgroup.com
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