Senior Scientist, Method Validation

Key Skills

AWS, Azure, Docker, JavaScript, Linux Operating system, Python Programming, R Programming, SQL

Job Description

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company based in South San Francisco, California, with offices in Salt Lake City, Utah and Zurich, that is dedicated to defeating neurodegenerative diseases through rigorous therapeutic discovery and development. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.

We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.

Opportunity:

The Sr. Scientist, Method Development will report to the Sr. Director, Quality in Salt Lake City. This position will primarily drive analytical method validation and defined strategies for QC in the Denali SLC new large molecule drug substance clinical manufacturing facility. This position will develop processes and procedures for the SLC QC defined by collaboration with TechOps for support of clinical product acceptance criteria. Additionally, routine review of cGMP documentation following Good Documentation Practices (GDP) to support assay data release activities prior to QA disposition. 

Responsibilities:

• Work with Analytical Development for methods in development to plan validation activities to support SLC QC and GMP requirements.
• Apply advanced scientific knowledge to analytical methods while following SOPs, GMPs and other industry required regulations.
• Apply quantitative methods: analyze data, evaluate results, form conclusions, and provide/implement process or document improvement.
• Independently design and execute qualifications, verifications, and validations to SLC manufacturing products related to project outcomes and expectations from Analytical Development group.
• Optimize assay conditions, improve product design and related processes and procedures, and troubleshoot technical issues.
• Collaborate cross-functionally with scientists, process scientists, analytical scientists, and leadership to support development of analytical methods for products.
• Maintain complete and comprehensive records of testing and findings.
• Write summaries and reports. Assist with revisions to SOPs, laboratory records and other documentation as assigned.
• Present complex technical findings/conclusions and project status updates to internal partners.
• Actively participate in routine maintenance and lab safety as required by SOPs and testing procedures.
• Prioritize studies and activities to align with project goals and be responsible for timely project completion.
• Assist in the training/coaching of new scientists. Provide technical and scientific leadership to other team members.
• Maintain a high level of professional expertise by staying current with scientific and industry literature, technologies, and products.
• Troubleshoot chemical methods and day to day operations and maintenance.
• Execute and manage required change controls, deviation, document change and CAPA processes for QC methods and processes if required.
• Document and report product or service-related quality events
• Support the development and implementation of standard operating procedures, policies and work instructions for processes governing quality services throughout the QC department.
• Support the development of raw material chemical and consumable standards.
• Clear, collaborative, and effective communication to discuss analytical and quality requirements with internal and external Denali partners including, manufacturing operations, MSAT, Quality and TechOps teams.
• Additional activities assigned or required as directed.

Required Qualifications:

• BS degree in core scientific discipline
• 10 years of related experience, with preference in clinical cGMP pharmaceutical QC.
• Working knowledge of analytical instrumentation (HPLC, LCMS, cell based assays, compendial verification, CE, IEF)
• Familiarity with large molecule drug substance manufacturing
• Knowledge of current USP/Ph. Eur./FDA/ISO/GMP standards and guidance
• Ability to effectively collaborate in a dynamic, fast paced, multidisciplinary team environment.
• Ability to work independently or in team environments under deadlines
• Excellent verbal and written communication skills
• Familiar with compliant software management and data integrity principles
• Ability to consistently identify mistakes and maintain a keen eye for detail
• Ability to closely follow quality standards and company quality expectations
• Proficiency with MS Office, quality system databases, electronic document management, and various analytical software solutions and electronic lab notebook (ELN).
• Committed to Denali values of growth, unity, grit and trust as well as values related to accountability, transparency, and scientific rigor.

Preferred Qualifications: 

MS or PhD in core scientific discipline

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Salary Range: $128,000.00 to $147,276.00. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers