Scientist I , Analytical Development & Quality Control

We are a high-performing, innovative, team-based organization, where collaboration, flexibility, initiative, energy, and motivation is essential. Reporting to the Senior Manager of ADQC, the primary role of the Scientist I in Analytical Development/Quality Control (ADQC) is to provide support to clinical programs by providing quality testing and delivering results in accordance with cGMP standards. Ensuring our products are safe for patients and fit for purpose.

The Scientist I in Analytical Development/Quality Control (ADQC) (QC focus) is responsible for authoring technical reports and protocols, performing routine analytical testing, data analysis, method qualification and method validation. The candidate will work closely with Process Development, Manufacturing, and Quality organizations to support raw material, in-process, release, and stability testing onsite. The successful candidate will be experienced with analytical techniques including but not limited to qPCR/ddPCR, AUC, Biolayer Interferometry (BLI), electrophoresis, ELISA, CE (CE-SDS, cIEF), and UV/Vis spectroscopy. The successful candidate with have working knowledge of cGMP testing regulations.

• Seeking Bay Area based candidates. GMP laboratory experience in the pharmaceutical industry required*

RESPONSIBILITIES:

Routine Sample Testing and Data Analysis: 30% of TIME

• Perform testing of raw material, in-process, release, and stability samples under cGMP

• Maintain accurate and well-organized laboratory records

• Perform primary review of QC raw data and trend results

• Draft technical reports using statistical analysis

• Review and present analytical data to cross-functional teams

• Author QC SOPs and complete change control

• Support the authoring and review of CMC sections of INDs

• Identify gaps and mitigate impact when industry guidelines or pharmacopeia sections are updated

• Train colleagues in areas of expertise

• Perform testing in support of process development

• Evaluate results against defined acceptance criteria

Method Qualification and Validation: 40% of TIME

• Implementation of phase-appropriate test methods and specifications.

• Identify trends that drive method requirements and ensure methods are fit for purpose

• Provide technical guidance as subject matter expert to QC staff

• Transfer, optimize and trouble-shoot analytical methods for use in Quality Control

• Draft analytical method Standard Operating Procedures

• Draft protocols and reports in support of analytical method qualifications.

• Execute testing in support of analytical method qualification and validation.

Quality System Oversight: 30% of TIME

• Maintain a cGMP compliant testing laboratory

• Perform equipment PMs, and manage equipment calibration documentation

• Support implementation of new Laboratory Information Management System (LIMS)

• Author technical documents for reference material qualification studies

• Lead laboratory investigations

• Other duties as assigned, nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

QUALIFICATIONS:

Education:

• Ph.D. in a relevant scientific field; MS Degree or Bachelor of Sciences degree in a technical discipline (Biochemistry, Biology, or related field) is required.

Experience:

• 8+ years of relevant hands on GMP laboratory experience in the pharmaceutical industry.

• Strong background in assay qualification/validation under ICH Guidelines.

• Knowledge of viral gene therapy (adeno associated viral vectors) preferred.

• Ability to work independently and work with others in designing and developing experiments, analyzing, and interpreting data in a rigorous way.

• Ability to multi-task and support more than one project simultaneously.

• Understanding and knowledge of key scientific software programs (SoftMax, QuantaSoft, etc.)

• Understanding and knowledge of regulatory requirements for biologic products and cGMPs.

• Strong organizational, analytical, and problem-solving skills.

• Strong communication skills both written and oral with demonstrated ability to present ideas and information and data effectively via one-on-one discussions, team meetings and partnership interactions.

• Experience with CMC activities for clinical programs.

• Strong regulatory and GMP acumen.

Skills:

• Sound understanding of scientific principles.

• General understanding of compendial testing, ICH qualification/validation.

• Strong verbal and written communication skills and effective interpersonal, technical discretion and troubleshooting skills are essential.

• Must be a team player, strong critical thinker, exhibit a willingness to meet project timelines and multitask effectively in a dynamic fast-paced environment under challenging timelines.

• Proficient or familiar with Microsoft based Windows programs: Word, Excel and PowerPoint.

BASE SALARY COMPENSATION RANGE:

Bay Area-based candidates: $128,000/yr. - $149,000/yr.