South San Francisco, California, United States · On-site
$159k–$207k/yr
Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our d…
Skills: Downstream purification, Process development, Biologics, Technology transfer, Process validation
Los Angeles, California, United States · Remote OK
$68k–$72k/yr
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and…
Skills: Troubleshooting, Installation, Preventive maintenance, Repair, Mechanical testing
Los Angeles, California, United States · On-site
Evaluate patients within twenty-four (24) hours, or 1 business day of physician referral. If unable to complete evaluation in 24 hours, documentation in medical record clearly defines cause for delay. • Develop effective…
Skills: Speech therapy, Patient evaluation, Treatment planning, Supervision, Documentation
Dublin, California, United States · On-site
STNA Dublin Post Acute Location: Dublin, OH Position Type: Full-Time Night Shift (Rotating weekend shift) Hours: 7:00pm – 7:00am $1,500 Sign-On Bonus for Full-Time STNA About Dublin Post Acute At Dublin Post Acute, we pr…
Skills: Resident care, Activities of daily living, Vital signs monitoring, Documentation, Infection control
Los Angeles, California, United States · Remote OK
$68k–$72k/yr
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and…
Skills: Troubleshooting, Installation, Preventive maintenance, Repair, Mechanical testing
Dublin, California, United States · On-site
STNA Dublin Post Acute Location: Dublin, OH Position Type: Full-Time Day Shift (Rotating weekend shift) Hours: 7:00am – 7:00pm $1,500 Sign-On Bonus for Full-Time STNA About Dublin Post Acute At Dublin Post Acute, we prov…
Skills: Resident care, Activities of daily living, Vital signs monitoring, Infection control, Patient documentation
Thousand Oaks, California, United States · On-site
$82k–$111k/yr
Career CategoryQualityJob Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious il…
Skills: Quality Assurance, Aseptic processing, GMP compliance, Drug product manufacturing, Visual inspection
Covina, California, United States · On-site
Easterseals Southern California transforms lives every day. For over a century, Easterseals has championed inclusion and independence—delivering essential services like early childhood programs, autism services, employme…
Skills: Therapy services management, Clinical supervision, Financial performance management, Budget development, Regulatory compliance
San Jose, California, United States · On-site
$28/hr–$37/hr
Work Flexibility: Onsite On Site Location: 5900 Optical Ct, San Jose, CA Shift: Monday – Friday, 8:00 AM – 5:00 PM Summary: As a Receiving Technician, you will support the in-house servicing, repair, and maintenance of …
Skills: Product Repair, Equipment Calibration, Quality Assurance, Documentation, ERP Systems
Irvine, California, United States · Hybrid
$77k–$117k/yr
Work Flexibility: Hybrid or Onsite What you will do – Act as primary liaison between multiple sites and cross-functional teams to gather and consolidate demand inputs, regulatory approval timeline, sales order, financial…
Skills: Demand Planning, Data Analysis, Microsoft Excel, ERP, PowerPoint
Bakersfield, California, United States · On-site
$87k–$96k/yr
Overview Working at Easterseals Southern California is an opportunity to make profound and positive differences in people's lives. At ESSC, you’ll join a team of caring colleagues who support each other, encourage collab…
Skills: Applied Behavior Analysis, Clinical Supervision, Case Management, Behavior Assessment, Parent Education
Oceanside, California, United States · On-site
$61/hr–$80/hr
Hours: Shift Start Time: 7 PM Shift End Time: 7:30 AM AWS Hours Requirement: 12/36 - 12 Hour Shift Additional Shift Information: Weekend Requirements: Every Other On-Call Required: No Hourly Pay Range (Minimum - Midpoint…
Skills: Neonatal Intensive Care, Patient Assessment, Care Planning, Neonatal Resuscitation, Critical Care
Chula Vista, California, United States · On-site
$61/hr–$90/hr
Hours: Shift Start Time: 7 PM Shift End Time: 7:30 AM AWS Hours Requirement: 12/36 - 12 Hour Shift Additional Shift Information: Weekend Requirements: Every Other On-Call Required: No Hourly Pay Range (Minimum - Midpoint…
Skills: Nursing process, Patient assessment, Care coordination, Critical thinking, Clinical judgment
Chula Vista, California, United States · On-site
$61/hr–$90/hr
Hours: Shift Start Time: 7 AM Shift End Time: 7:30 PM AWS Hours Requirement: 12/36 - 12 Hour Shift Additional Shift Information: Weekend Requirements: Every Other On-Call Required: No Hourly Pay Range (Minimum - Midpoint…
Skills: Nursing process, Patient assessment, Care coordination, Critical thinking, Patient advocacy
San Diego, California, United States · On-site
$25/hr–$34/hr
Hours: Shift Start Time: 8 AM Shift End Time: 5 PM AWS Hours Requirement: 8/40 - 8 Hour Shift Additional Shift Information: Mondays/Wednesdays/Thursdays Weekend Requirements: As Needed On-Call Required: No Hourly Pay Ran…
Skills: Clinical competencies, Medication administration, Patient care, Infection control, Electronic health records
Santa Maria, California, United States · On-site
If you are a current YAI employee, please click this link to apply through your Workday account. Key/Essential Functions & Responsibilities Maintains an active caseload of up to 20 – 25 individuals referred for START Ser…
Skills: Case management, Crisis intervention, Assessment and evaluation, Systemic consultation, Behavioral health
Watsonville, California, United States · On-site
If you are a current YAI employee, please click this link to apply through your Workday account. • Oversees the milieu and therapeutic programming of the assigned program, including the development and implementation of …
Skills: Program Administration, Staff Supervision, Therapeutic Programming, Interdisciplinary Team Coordination, Regulatory Compliance
Santa Maria, California, United States · On-site
If you are a current YAI employee, please click this link to apply through your Workday account. Key/Essential Functions & Responsibilities Maintains an active caseload of up to 20 – 25 individuals referred for START Ser…
Skills: Case management, Crisis intervention, Assessment and evaluation, Systemic consultation, Behavioral health
Los Angeles, California, United States · Hybrid
$95k–$105k/yr
Keck School of Medicine USC, Finance Department The USC Keck School of Medicine Finance Department is seeking a Financial Analyst II position. Working under the supervision of the Associate Finance Director, the Financia…
Skills: Financial Analysis, Financial Reporting, Budgeting, Financial Modeling, Forecasting
Los Angeles, California, United States · Remote OK
$23/hr–$40/hr
Serves as primary point of contact for access to USC academic medical centers and USC Health Sciences Campus. Under the direction of the Access Center Leadership, the Lead will serve as the point of contact for the team …
Skills: Patient Access, Customer Service, Medical Scheduling, Insurance Verification, Leadership
South San Francisco, California, United States • On-site
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The role serves as the downstream purification technical lead for commercial and late-stage biologics, overseeing process verification, investigations, and cross-site alignment. It also involves managing lifecycle activities, including process improvements, tech transfer validation, and regulatory filing updates.
Candidates typically require a PhD in a scientific discipline and over 10 years of related work experience. Strong expertise in downstream purification, process characterization, and regulatory support for commercial manufacturing is essential.
Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. 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.
Key Accountabilities/Core Job Responsibilities:
Serve as downstream purification technical lead for commercial manufacturing including continued process verification, investigations, deviation support, and cross-site alignment.
Support lifecycle management activities for commercial products, including process improvements, tech transfer validation activities, local and cross-site change management, regulatory filing updates (CBE, PAS, Ex-US expansion), and responses to health authority questions.
Drive technical continuity and alignment across CDMO and internal manufacturing sites by ensuring process understanding, lessons learned and technical decisions are consistently captured and applied.
Design, oversee, and interpret small-scale process development studies that inform large-scale manufacturing decisions, support root-cause investigations, and enable lifecycle improvements.
Build and maintain technical risk assessments (e.g., FMEA) and process history files to support robust commercial manufacturing and future late-stage programs.
Support the incoming late-stage process development pipeline and commercial programs by applying best practices, platform knowledge, and prior manufacturing experience while contributing to standardization of lifecycle management practices.
Qualifications/Skills:
Typically requires a PhD in Biology, Biochemistry, Chemical Engineering, or a related scientific discipline, plus 10+ years of related work experience.
Strong experience with commercial process support and technology transfers, downstream purification process characterization, and process validation.
Experience managing post-approval changes as a technical SME in collaboration with site, regulatory, supply chain and quality.
Experience reviewing batch records, supporting deviation investigations, and assessing process performance during manufacturing campaigns.
Proven track record of representing bioprocess functions in cross-functional teams and working effectively with CDMOs.
Broad experience in process characterization, design of experiments, and analytics.
Experience developing downstream purification processes to support early- or late-stage clinical production.
Expertise in AKTA protein purification systems, antibody characterization methods, and other biophysical techniques.
Excellent critical thinking, scientific problem-solving, and communication skills
Familiarity with BLA authoring and post-approval regulatory support is preferred.
This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
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.
Denali Therapeutics is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier using our proprietary TransportVehicle™ platform. We discover, develop and deliver medicines for people living with neurodegenerative, lysosomal storage and other serious diseases.
Offices: 161 Oyster Point Blvd, South San Francisco, California 94080, US · 5843 W Amelia Earhart Dr, Salt Lake City, Utah 84116, US
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