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Added 23 mins ago
Site Master Scheduler
GE Precision Healthcare LLC
United States
Bachelor’s degree in Supply Chain, Engineering, Operations or Business with a minimum of 2 years of relevant experience in master scheduling, production planning or supply planning in a…
Added 25 mins ago
GA
Principal Technical Product Manager, Data & Platform
GE Aerospace
Glen Allen, VA · Charlottesville, VA
- $152,000 to $222,000 USD / year
Own the access model. Own the Foundry security posture: design and maintain role-based access controls (RBAC), fine-grained security roles and markings, and scalable access provisioning, so…
Added 25 mins ago
GA
Sr Staff Applications Operations Engineer – Engineering Tools Automation & AI Ops
GE Aerospace
Charlottesville, VA · Glen Allen, VA
- $131,000 to $174,000 USD / year
Serve as the senior technical operations authority across engineering application pods (software, hardware and electronic design, and project and portfolio management tools) for US and UK…
Added 25 mins ago
MGR COMPUTER SYS SECURITY 2 (IAM & APPS)
Huntington Ingalls Industries
Newport News, VA
Bachelor's Degree and 6 years of progressive technical experience in research, engineering and design; Master?s Degree and 4 years of relevant experience
Added 25 mins ago
Audiovisual Design & Integration Specialist (Senior or Lead)
The Boeing Company
Herndon, VA
Boeing Defense, Space & Security (BDS) / Intelligence Systems (IS) is seeking motivated and self-starting Audiovisual Design & Integration Specialist (Senior or Lead) for a position based…
Added 25 mins ago
Principal Identity Access and Zero Trust Architect - TS/SCI with Polygraph
General Dynamics Information Technology
Chantilly, VA
GDIT is seeking an Enterprise Identity and Access Architect to lead the design and ownership of identity, authentication, authorization, privileged access, and Zero Trust access…
Added 25 mins ago
End User Computing Architect - Azure Virtual Desktop and VDI - TS/SCI with Polygraph
General Dynamics Information Technology
Chantilly, VA
10+ years of enterprise EUC, VDI, endpoint, or infrastructure engineering experience, including 5+ years in architecture or lead design roles.
Added 25 mins ago
Senior Cloud Platform and DevSecOps Engineer - TS/SCI with Polygraph
General Dynamics Information Technology
Chantilly, VA
DevSecOps,Linux,Microsoft Azure,Microsoft Windows,Systems Engineering
Added 25 mins ago
Senior Associate, Data Scientist - US Card (Applied GenAI)
Capital One
McLean, VA
Build machine learning and NLP models through all phases of development, from design through training, evaluation, and validation; partnering with engineering teams to operationalize them…
Added 25 mins ago
Senior Associate, Data Scientist - Credit Line Increase Program
Capital One
McLean, VA
…Development team will also partner with the credit program to design the model for destination usage and enable business policies backed by…
Added 25 mins ago
Senior Associate, Product Management, Card Data
Capital One
McLean, VA
At least 1 year of product management experience or at least 1 year of experience in product design, agile delivery, business analysis, data science, or software engineering
Added 25 mins ago
Principal Associate, Data Scientist - Alternative Data Strategy
Capital One
McLean, VA
Build machine learning models through all phases of development, from design through training, evaluation, validation, and implementation
Added 25 mins ago
Senior Associate, Data Scientist - Alternative Data Strategy
Capital One
McLean, VA
Build machine learning models through all phases of development, from design through training, evaluation, validation, and implementation
Added 25 mins ago
Associate Delivery Consultant – Modernization, ProServe A2C Delivery , ProServe A2C Delivery
Amazon
Arlington, VA · Herndon, VA
…(AWS). In this role, you'll work closely with customers to design, implement, and manage AWS solutions that meet their technical requirements and business objectives. You'll be a key player…
Added 25 mins ago
Cloud Engineer
Maximus
Richmond, VA
Research, design, develop, run tests, and evaluate systems supporting cloud implementation and integration with cloud service providers, applying principles and techniques of computer…
Added 26 mins ago
FIRE SAFETY WATCH CVN - ENGINEERING TECHNICIAN 1
HII
Newport News, VA
…technical data, such as laboratory or material test results and engineering design changes. Produces engineering documentation, reports, drawings (flow charts, block diagrams, and…
Added 26 mins ago
METROLOGY TECHNICIAN 2
HII
Newport News, VA
…electronic 3D instruments. Uses 3D model based software and design drawings to plan and execute the measurement survey including the analysis of the collected data to the end user.…
Added 27 mins ago
CNC Machining Operator
Staff Management | SMX
White, GA
Analyzes job orders, drawings, blueprints, specifications and design data in order to calculate dimensions, tool selection, machine speeds and feed rates.
Added 27 mins ago
CNC Machinist
Staff Management | SMX
Snoqualmie, WA
…work cross-functionally to ensure on-time delivery, and help design tools and fixtures that keep our operation running at its…
Added 27 mins ago
Construction Electrical Estimator
Staff Management | SMX
Sandston, VA
4 or more years estimating or cost control and or engineering experience in the commercial or industrial construction industry; design quality project experience preferred.
Added 27 mins ago
Construction Electrical Superintendent - Data Center
Staff Management | SMX
Lithia Springs, GA
Have a complete understanding of the project design, drawings, specifications, and installation requirements.
Added 27 mins ago
Electrical Construction Estimator - Data Center
Staff Management | SMX
Lithia Springs, GA
4 or more years experience in estimating or cost control and/or engineering experience in the commercial or industrial electrical construction industry.
Added 27 mins ago
Electrical Superintendent - Data Center
Staff Management | SMX
Sandston, VA
Have a complete understanding of the project design, drawings, specifications, and installation requirements
Added 27 mins ago
Electrical Estimator
Staff Management | SMX
Suffolk, VA
4 or more years estimating or cost control and or engineering experience in the commercial or industrial construction industry; design quality project experience preferred.
Added 27 mins ago
PCA Production Line Lead
Staff Management | SMX
Indianapolis, IN
Lead real-time troubleshooting with engineering teams

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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