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Added 1 min ago
Model Development & Decision Science Director
Columbia Bank
Lake Oswego, OR
Expertise in quantitative modeling, credit portfolio modeling, CECL, stress testing, scenario analysis, statistical modeling, machine learning, predictive analytics, and AI/ML solution…
Added 2 mins ago
Instructor: Outdoor Products
Oregon State University
Bend, OR
OSU-Cascades invites applications for a full-time (1.00 FTE), 9-month fixed-term Instructor position in Outdoor Products. Reappointment is at the discretion of the Senior Associate Dean .
Added 2 mins ago
Registered Nurse - Vascular Access
Veterans Affairs, Veterans Health Administration
Portland, OR
Added 2 mins ago
Registered Nurse - Vascular Access (Intermittent)
Veterans Affairs, Veterans Health Administration
Portland, OR
Added 2 mins ago
Instructional Designer - Healthcare Consulting
Huron Consulting Group
Portland, OR
We’re looking for an Instructional Design Associate to join our team. You’ll be part of our commercial eLearning product team within the Healthcare Consulting Business Unit of Huron’s…
Added 2 mins ago
Clinical Testing Automation Analyst
Highmark Health
Salem, OR
The Associate Technical Analyst supports the development, execution, and maintenance of automated testing solutions that improve the quality, reliability, and efficiency of clinical and…
Added 2 mins ago
Senior Product Owner/Manager, Next Best Action Configuration
Humana
Salem, OR
Maintain visibility into actions and treatments moving through definition, configuration, testing, and implementation.
Added 2 mins ago
Lead Service Designer
Humana
Salem, OR
…concept initiatives across framing, research, service design, testing, and planning for implementation. We are looking for a highly curious and hardworking designer who is ready to dive…
Added 2 mins ago
Lead Product Manager, Channels
Humana
Salem, OR
Partner with business stakeholders to support testing, validation, and readiness activities prior to production deployment.
Added 2 mins ago
Configuration Lead, Compensation
Humana
Salem, OR
…support business objectives, regulatory requirements, and the associate experience. The Lead provides strategic guidance on Workday capabilities, compensation processes, and leading…
Added 2 mins ago
Lead Product Owner
Humana
Salem, OR
Support the testing and validation of business rules and product capabilities prior to implementation.
Added 2 mins ago
Associate Cobol Technical Analyst
Highmark Health
Salem, OR
Support various aspects of requirements testing (e.g. testing plan, scenarios, documentation, defect management) to ensure minimal production defects are realized and completing analysis of…
Added 2 mins ago
GA
Principal Technical Product Manager, Data & Platform
GE Aerospace
Salem, OR
- $152,000 to $222,000 USD / year
Added 2 mins ago
GA
Sr Staff Applications Operations Engineer – Engineering Tools Automation & AI Ops
GE Aerospace
Salem, OR
- $131,000 to $174,000 USD / year
Bachelor's degree from an accredited university or college with a minimum of 5 years of professional experience OR an Associate's degree with a minimum of 8 years of professional experience…
Added 10 mins ago
Accounting Specialist
University of Kansas
Lawrence, KS
…of various systems utilized in office operations. Engage in testing data for new systems, system upgrades, and/or new…
Added 10 mins ago
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Clinic Account Representative
Abbott
Overland Park, KS
- $22.5 to $45 USD / hour
Associate degree or equivalent combination of education and experience.
Added 15 mins ago
UO
Post-Doctoral Associate
University of Colorado Denver
Boulder, CO
- $52,416 USD / year
The postdoctoral associate will be responsible for designing and developing new catalysts, testing new reactions, optimizing conditions to improve yields, exploring substrate scope, and…
Added 20 mins ago
BV
Laboratory Analyst I
Bureau Vertias North America
TN
- $18 to $20 USD / hour
The Laboratory Analyst I, CHNOS is responsible for performing elemental, physical property, and wet chemistry testing on a wide variety of client samples using analytical chemistry…
Added 20 mins ago
Operations Helper - Entry Level 2026
Eastman
Kingsport, TN
Candidates must be able to demonstrate basic knowledge and skills by completing the ACT Workkeys assessment testing and attain required scores within 12 months of hire date.
Added 21 mins ago
Sr. Program Manager DA Eligibility, Worldwide DSP Performance
Amazon
Nashville, TN
…screenings program globally - including background checks, drug testing, as well as alternative screening methodologies. The PM owns the creation and implementation of policy, programmatic…
Added 21 mins ago
Senior Solution Architect
HCA Healthcare
Nashville, TN
Develop and maintain automation testing best practices and standards for enterprise use
Added 21 mins ago
GI
Cashier/Sales Associate - Store 6010
Gpm Investments LLC
Kingsport, TN
- $11 to $13 USD / hour
…screening in accordance with company policy and applicable law. Our testing protocols are designed to comply with state-specific regulations, including those related to lawful off-duty…
Added 30 mins ago
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IT Support Analyst
Leapfrog Services, Inc.
Atlanta, GA
- $50,000 to $55,000 USD / year
Stable internet connection and ability to work remotely using Leapfrog-provided equipment when participating in after-hours on-call support or planned disaster recovery testing.
Added 38 mins ago
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Full Stack Quality Assurance Engineer
Carrier
Kennesaw, GA
- $79,000 to $158,000 USD / year
…performance through system-level, regression, and performance testing. You will collaborate with Scrum teams throughout the development lifecycle for Carrier’s Commercial Energy Management…
Added 55 mins ago
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OnSite Specialist - St. Louis, MO
Stryker
Saint Louis, MO
- $21.58 to $29.2 USD / hour
+ Bachelor's or Associate's degree, or equivalent certifications.

Actalent

Associate Director, Biologics Analytical Development

Durham, NC, United States

$165,000 to $220,000 USD / year

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Job details

Pay: $165,000 to $220,000 USD / year
Posting language: English
Posted: Nov 5, 2026

Original job description

Job Title: Associate Director, Biologics Analytical DevelopmentJob DescriptionWe are seeking an Associate Director of Biologics Analytical Development to provide scientific leadership and strategic direction for analytical sciences across a growing biologics development portfolio. This position will play a key role in establishing analytical strategies, advancing late-stage analytical development, and ensuring robust, phase-appropriate analytical methods and control strategies throughout clinical development and toward commercialization. The role requires deep expertise in biologics analytical development, CMC regulatory knowledge, strategic leadership, and experience managing external development partners.

Responsibilities

Establish and evolve analytical strategies supporting multiple biologics development programs.
Develop scientific standards, best practices, and analytical governance across development programs.
Identify opportunities to strengthen analytical capabilities, technologies, and external partnerships.
Provide scientific guidance and mentorship to analytical scientists.
Serve as a senior technical resource for complex analytical challenges and guide teams toward scientifically sound solutions.
Provide scientific leadership for analytical lifecycle management including method validation, comparability strategies, specification development, and reference standard strategies.
Guide analytical planning for late-stage clinical development, process validation, commercial readiness, and regulatory submissions.
Support phase-appropriate product characterization and the continued development of product and process knowledge.
Lead or provide technical direction for investigations involving out-of-specification or out-of-trend analytical results.
Partner with analytical project leads to establish consistent scientific and analytical approaches across development programs.
Collaborate across Cell Line Development, Upstream and Downstream Process Development, Formulation Development, Bioassay, Manufacturing, Quality, Regulatory Affairs, and related technical functions.
Provide analytical expertise during technology transfer, process validation, and preparation for commercial readiness.
Provide scientific oversight of external analytical laboratories, CROs, and development partners.
Lead technical interactions with external partners.
Support analytical technology transfers, due diligence activities, and regulatory inspections.
Evaluate emerging analytical technologies and recommend implementation where scientifically appropriate.

Essential Skills

Strong background in biologics analytical development and Analytical CMC.
Experience advancing biologic products through IND and clinical development.
Expertise in analytical lifecycle activities such as method validation, comparability, specification development, reference standards, and analytical control strategies.
Experience leading multidisciplinary CMC teams within a matrix organization.
Experience managing CDMOs, CROs, external laboratories, or other development partners.
Strong understanding of CMC regulatory expectations for biologic products.
Demonstrated experience supporting the development of biologic products.
Demonstrated experience advancing biologics through IND and clinical development.
Experience leading multidisciplinary CMC teams in a matrix environment.
Experience managing CDMOs and external development partners.
Strong scientific communication, leadership, and project-management capabilities.

Additional Skills & Qualifications

Ph.D. in Chemical Engineering, Biochemical Engineering, Biological Sciences, or a related scientific discipline with 6+ years of pharmaceutical or biotechnology Analytical CMC experience OR B.S. or M.S. with 12+ years of experience.
Experience supporting Phase 2 and/or Phase 3 clinical development.
Experience supporting commercial readiness and BLA submissions.
Experience addressing questions from U.S. or global health authorities.
Experience with technology transfer, comparability, process validation, and analytical lifecycle management.
Experience supporting multiple concurrent development programs within a biotechnology environment.

Work EnvironmentThe position is based in Durham, NC, and requires onsite work in a full-time, direct hire capacity. The role involves collaboration with cross-functional teams, including Cell Line Development, Process Development, Quality, Regulatory Affairs, and Manufacturing. The work environment is dynamic and involves managing external development partners, including CDMOs and CROs, to oversee testing and specialized development activities. Job Type & LocationThis is a Permanent position based out of Durham, NC. Pay and BenefitsThe pay range for this position is $165000.00 - $220000.00/yr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.Competitive salary and health benefits, 401k. Opportunities for training and career advancement. Collaborative and inclusive work environment. Access to cutting-edge research and technology. Job Type & LocationThis is a Permanent position based out of Durham, NC. Application DeadlineThis position is anticipated to close on Nov 13, 2026. Workplace TypeThis is a fully onsite position in Durham,NC.About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

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Skills

Leadership
Regulatory affairs
Inspection
Communication skills
Project management
Chemical engineering
Biotechnology
Collaboration
Research

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