Process Development Scientist Jobs in California

Keep current with all regulatory guidelines, compendia requirements, and technical innovations.

Strong knowledge of virus, protein and DNA/RNA chemistry

Knowledge and expertise in principles and practice of current Good Manufacturing Practices (cGMP)

Demonstrated verbal and written skills in technical reports and documents

Experience in separation technologies including multiple modes such as capillary electrophoresis, AUC and mass spectrometric in analyses of biologics

Experience in statistical analysis using JMP or other software

Offer guidance and lab-level leadership for incumbent associates, with possibility for 1-2 direct report(s)

May include approximately 20% remote work, with flexibility based on project needs

BS+8 / MS+6 / PhD+2 years minimum industry experience in a process development or MSAT role

Excellent communication and presentation skills. Capability to convey complex technical information in a clear, concise, and influential manner

Prior experience developing purification processes for virus, VLP, or gene therapy vectors for GMP clinical manufacturing.

Working knowledge of the GMP manufacturing environment, which may include involvement in process transfer, review of batch records/deviations/CAPAs, or ‘person-in-plant’ duties.

Strong project management and organizational skills.

Leads technical support activities related to maintaining commercial product supplies through management of internal and external resources.

Knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing is preferred.

Contributes to user requirement specification and provides expert process technical support to utilize and validate new and improved technologies.

Experience with statistical data analysis tools is preferred.

Excellent troubleshooting skills and ability to solve complex technical issues.

Ensure compliance with regulatory requirements and safety protocols in all laboratory activities, maintaining a strong focus on quality and compliance.

Stay up-to-date with the latest scientific and technological advancements and apply this knowledge to advance product development.

Substantial experience in experimental design, execution, and data analysis within a scientific research and development environment, focusing on process optimization.

Substantial experience developing and ensuring adherence to Standard Operating Procedures (SOPs).

Outstanding analytical, problem-solving, and critical thinking skills, with a proven ability to tackle complex scientific challenges.

Excellent written and verbal communication abilities, including effectively communicating complex scientific concepts to technical and non-technical stakeholders.

Coordinate effectively with different functional teams from Product Development, Bioinformatics, Operation, Quality, Product management, etc.

Knowledge of statistical methods and data analysis experience is required

Proven experience of working in cross-functional development teams and strong communication skills

Knowledge and experience with single cell genomics is strongly desired.

Trouble shooting skills to address customer complaints

Minimum of 3 years of demonstrated experience in R&D or research laboratory environment in genomics technologies or related field.

You have superior skills and experience, and constantly strive to be world-class in what you do

See below for role responsibilities and desired qualifications.

Experience with viral vector production.

Experience in process development planning and strategy is required; familiarity with preclinical drug development processes is a bonus.

Experience with technology transfer to CDMO/manufacturing facilities, and process characterization experience is a plus.

Competitive salary of $100,000 - $180,000/year, commensurate with experience

Develop people and project management skills to allow large multi-department projects to be carried out efficiently.

Employ advanced skills in the design and data analysis of experimental studies

Able to integrate experimental design expertise with technical knowledge

Manage CDMO(s) and collaborate with internal and external teams to develop drug products

Strong experience with pre-formulation and parenteral formulation development in the areas of protein, oligonucleotide or gene therapy

Experience in formulation characterization & analytical instrumentation.

Strong communication and organizational skills to manage multidisciplinary projects.

Hands-on experimental experience in molecular biology. Preferrably in genomics, or enzymology.

Strong written and oral communication skills.

Experience with customer. Experience in Sequencing-based technology development.

Develop new NGS library prep and Sequencing workflows for Complete Genomics’ sequencing platform.

Design and execute experiment plans to demonstrate technical feasibility.

Manage complex calendar for VP of Process Development

Manage and facilitate agendas for weekly meetings. Responsible for tracking action items within

Bachelor’s degree (or equivalent experience) OR

Associate Degree and 2+ years of administrative experience supporting an Executive Director or VP level OR

High School Degree and 3+ years of administrative experience supporting an Executive Director or VP level

Experience working in a team environment with other administrative assistants

Comprehensive and solid experience in general molecular biology and cell culture techniques are required for this role.

Extensive experience in bioanalytical methods and assay development across multiple platforms (e.g., ELISA, MSD, Luminex) is highly desired.

In-depth experience in multi-parameter flow cytometry (e.g., surface staining, nuclear antigens, viability, proliferation, cytokines, etc.), including panel development and troubleshooting.

Experience in gene editing and genome engineering technologies.

Experience in stem cells and/or tissue biology.

Experience with performance of experiments in mouse models is a plus.

Knowledgeable, with good technical insight of molecular biology, particularly PCR and MSP, DNA extraction and modification

Knowledge FDA quality systems regulations (QSR) and ISO standards (ISO 13485 or ISO 9001-2008) a plus.

Excellent mathematical and analytical skills, reasoning ability, critical attitude and communication skills

World class healthcare company, providing significant career development and financial opportunities

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