Associate Consultant, CMC Position Summary: The Associate Consultant is an entry-level consulting role responsible for supporting scientific and regulatory project execution. This position involves direct contributions t…
Skills: Technical writing, Regulatory affairs, CMC, Biotechnology, Process development
Description Security Clearance: Active Top Secret security clearance with eligibility and ability to obtain SCI access. Travel Requirement: Up to 50% Sherpa 6 is seeking an experienced Network Engineer with a strong cybe…
Love Where You Work! If working for a team of dynamic professionals that create award winning projects for some of the world’s most successful companies sounds exciting, rand* construction corporation is where you …
Skills: Construction Management, Project Management, Procore, Blueprint Reading, Safety Protocols
Senior Telecommunications Equipment Installer and Repairer
Alexandria, Virginia, United States · Hybrid
Senior
GovCIO is currently hiring a highly experienced Senior Telecommunications Equipment Installer and Repairer to support critical data center operations, infrastructure modernization, and platform engineering activities for…
Skills: Data center operations, Infrastructure modernization, Structured cabling, Power systems, UPS systems
ANSER
Tactical Communications Policy and Strategy Analyst
Alexandria, Virginia, United States · On-site
$143k–$208k/yr
Senior+
Company Overview: ANSER enhances national and homeland security by strengthening public institutions. We provide thought leadership for complex issues through independent analysis, and we deliver practical, useful soluti…
Skills: Tactical Communications, Policy Analysis, Systems Engineering, Network Strategy, Defense Acquisition System
Outreach Coordinator The Outreach Coordinator is an entry-level data and research role focused on identifying prospective members, organizing and segmenting audience data, and preparing qualified contacts for the Members…
Skills: Research, Data management, List building, Data hygiene, CRM
Job Description: Founded in 1912, ITW (NYSE: ITW) is a global industrial company built around a differentiated and proprietary business model. The company’s seven industry-leading segments leverage the ITW Business Model…
Skills: Machining, CNC operation, Quality inspection, Preventive maintenance, Time management
Philadelphia, Pennsylvania, United States · Hybrid
Senior$94M raised
We are looking for a Senior DevOps Engineer to join our PISA DevOps team in Alexandria, VA. This is an amazing opportunity to work on several growing products in the Clarivate Intellectual Property Group. We would love t…
Job Title Maintenance Technician Job Description Summary Responsible to assist with the operation troubleshooting, diagnostics, housekeeping, and repairs on commercial buildings, industrial systems, vehicles, grounds, an…
General Infomatics, Inc. is a trusted partner to U.S. government agencies nationwide, delivering program support, healthcare services, strategic technology solutions, and knowledge management under the highest standards …
SAIC is seeking an Economic Security Analyst to support our team of qualified, diverse, and highly motivated individuals supporting the Office of the Under Secretary of War for Research and Engineering (OUSW(R&E)). The q…
Position Overview We are seeking an experienced Operations & Maintenance (O&M) Project Manager to support DHS/FPS facility operations, maintenance, repair, and project activities. The O&M Project Manager will coordinate …
Space Planner- Onsite (US Citizens Eligible to Obtain Clearance)
Alexandria, Virginia, United States · On-site
Senior
Position Overview We are seeking an experienced Space Planner to support DHS/FPS with workplace planning, space utilization, site assessments, relocation planning, and office/facility reconfiguration activities. The Spac…
Skills: Space planning, Workplace planning, Space utilization, Site assessments, Relocation planning
Description Travel Requirement: As needed, up to 50% Security Clearance: Active DoD Top Secret clearance with SCI eligibility Sherpa 6 is seeking an experienced Senior Counter-Unmanned Systems (C-sUAS) Systems Integrator…
Skills: Systems integration, C-sUAS, Technical advisory, Systems engineering, Data flow analysis
E&M Technologies, Inc.
Critical Minerals All Source Analyst
Alexandria, Virginia, United States · On-site
Senior
Description POSITION: Critical Minerals All Source Analyst WORK LOCATION: Alexandria, VA JOB CATEGORY: Intelligence JOB TYPE: Full Time REQUISITION ID: EM43-040 CITIZENSHIP: United States Citizen CLEARANCE TYPE: TS/SCI W…
TYLin is a globally recognized, full-service infrastructure consulting firm committed to providing innovative, cost-effective, constructible designs for the global infrastructure market. With over 3,000 employees through…
Skills: Low-voltage Power Distribution, Medium-voltage Electrical Distribution, Lighting Design, Emergency Power Systems, Electrical Calculations
Software Architect, Lead The Opportunity: This capability is transforming how mission stakeholders make sense of complex, multi‑INT environments. Built around a team of AI agents that fuse, detect, and forecast activity …
Skills: Software architecture, Java, C++, Python, Distributed systems
TYLin is a globally recognized, full-service infrastructure consulting firm committed to providing innovative, cost-effective, constructible designs for the global infrastructure market. With over 3,000 employees through…
Skills: Project Scheduling, Primavera P6, CPM Scheduling, Construction Management, Work Force Planning
TYLin is a globally recognized, full-service infrastructure consulting firm committed to providing innovative, cost-effective, constructible designs for the global infrastructure market. With over 3,000 employees through…
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
$90k–$115k/yr
Full-time
postgraduate degree
Posted 6d ago
~40 hrs/week
Responsibilities
The Associate Consultant will support scientific and regulatory project execution through technical writing, data analysis, and project coordination. They will contribute to CMC and cGMP documentation while working closely with cross-functional teams to advance client projects.
Requirements
Candidates should hold a Ph.D. in a scientific discipline with 1-3 years of relevant experience, or a master's degree with at least three years of industry experience. Proficiency in biotechnology process development, manufacturing, and regulatory technical writing is required.
Full job description
Associate Consultant, CMC
Position Summary:
The Associate Consultant is an entry-level consulting role responsible for supporting scientific and regulatory project execution. This position involves direct contributions to client deliverables through technical writing, research, and data analysis, as well as support in project coordination and proposal development. The role requires foundational scientific knowledge in one or more of the relevant technical disciplines, strong organizational and communication skills, and a demonstrated interest in regulatory affairs and product development. The Associate Consultant will work closely with project teams and senior staff while developing subject matter expertise and consulting skills.
The Associate Consultant, CMC, position will be responsible for providing technical and regulatory support and advice under the guidance of Senior or Principal Consultants, or in inter-disciplinary, cross-functional teams. This support will encompass a working knowledge of biotechnology process development and manufacturing and regulatory technical writing for Module 3 sections for INDs and/or BLAs.
The CMC unit at Biologics Consulting is responsible for developing, implementing, and directing regulatory, quality and technical strategies for new and mature products and interacting with regulatory agencies by providing strategic input, risk assessments and overseeing preparation of regulatory submissions.
Biologics Consulting Group, Inc. works with medical devices, biologics and pharmaceutical companies to advance patient health.
Responsibilities:
Assist in the coordination and management of scientific projects across multiple therapeutic areas.
Contribute to the preparation of CMC and cGMP technical documents, including regulatory submissions (Module 3), literature reviews, and scientific reports.
Participate in proposal preparation and development to support business growth.
Actively pursue knowledge development in regulatory affairs and industry-specific scientific topics.
Work closely with cross-functional teams and senior consultants across multiple projects.
Manage competing priorities effectively while meeting deadlines and maintaining high-quality work.
Exhibit strong verbal and written communication skills, tailored to scientific and professional audiences.
The incumbent will lead by example and foster a team environment, ensuring an overall ‘culture of quality’ in the high-quality execution of services provided to clients.
Requirements:
Ph.D. in related scientific or technical discipline (such as, Biotechnology, Biotech Engineering or Biochemistry) strongly preferred with 1-3 years of experience in process development, manufacturing and technical writing at a biopharma/biotech company or in support of a CDMO; previous consulting experience not required.
Alternatively, a master's degree in a related discipline and at least three years of relevant industry, consulting, and/or government experience in manufacturing or process development.
Demonstrated interest in product development and regulatory affairs.
Proficient understanding of current biotechnology process development approaches and manufacturing of drug substances and/or drug products.
Proficient understanding of analytical assays is a plus
Ability to evaluate, synthesize, and summarize scientific data effectively.
Experience reviewing and/or authoring scientific or regulatory documents.
Strong verbal and written communication skills, with a clear ability to adapt to scientific and regulatory audiences.
Collaborative mindset and eagerness to learn.
Strong interpersonal skills and professionalism in client-facing communications.
Previous internship, research, or academic project work demonstrating applied scientific and communication skills is a plus. However, this experience must have provided a minimum of one year of experience in process development and/or manufacturing.
Ability to create effective PowerPoint presentations and leverage current software and tools.
Stay abreast of changing trends and current events within the industry.
Key Performance Indicators:
Achievement of billable hours target
Timeliness and quality of deliverables
Ability to manage multiple assignments effectively
Engagement in professional development activities
Positive collaboration and support of project teams
Essential Skills:
Proficient with MS Office Suite and Copilot or equivalent AI tools for technical writing, graphics and formatting.
English language facility in technical writing.
Proficient in math, diplomacy and leadership skills, professionalism, time management, and statistics for regulatory dossier data assessment and presentation formatting.
Professional presentation to clients and ability to muti-task and work independently and collaboratively while maintaining confidentiality.
The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Leading FDA Regulatory & Product Development Consulting Firm for Biologics, Drug, Combination Products & Medical Devices
Industry
Business Consulting and Services
Company size
51-200 employees
Founded
1993
Headquarters
Alexandria, Virginia
LinkedIn followers
6,345
ABOUT
Biologics Consulting is a complete FDA regulatory and product development consulting firm for cell & gene therapy, biologics, pharmaceuticals, and medical devices. In the three decades since its founding, Biologics Consulting has become the go-to consulting partner for companies large and small seeking to bring innovative, safe, and effective products to market in the US. Our team of regulatory scientists, FDA consultants, and professional services staff has decades of industry and FDA experience that allows us to provide an unparalleled insider perspective for our clients.
OUR DIFFERENCE
The Biologics Consulting difference is all about the unique combination of regulatory expertise we have under one roof. Our team has depth of knowledge and breadth of experience across all product types and development pathways. This value proposition allows us to address the full scope of a client’s regulatory and product development challenges from preapproval to commercialization.
OUR EXPERIENCE AREAS
- Biologics
- Medical Devices
- Pharmaceuticals
- Biosimilars
OUR SERVICES
- CONSULTING – Regulatory, Product Development, Clinical Planning and Quality support.
- SUPPORT SERVICES – Medical Writing, e-Publishing & Submissions, US Agent Services, Due Diligence
OUR CLIENTS
Our clients span the industry, from established multi-national pharmaceutical, biotechnology, and medical device companies to academic and research institutions. We also support small biotech and medical device start-ups. Since our founding, we have professionally services over 4,500 clients from 58 different countries.
Offices: 100 Daingerfield Rd, Alexandria, Virginia 22314, US
Biotherapeuticsregulatory strategyproduct developmentpreclinical safety testingclinicalmedical devicesvaccinespharmaceuticalscell and gene therapye-publishing
How much do Engineering jobs in Alexandria, VA pay?
Based on 269 listings with disclosed salaries, most engineering jobs in Alexandria, VA pay between $72k–$185k per year. Individual offers vary with seniority, company size, and specialization.
How many Engineering jobs are open in Alexandria, VA right now?
There are currently 393 open engineering positions in Alexandria, VA listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Engineering roles in Alexandria, VA?
Companies currently hiring include Leidos, Booz Allen Hamilton, CACI International Inc, ANSER, RBF Consulting, a Company of Michael Baker International, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Engineering jobs in Alexandria, VA?
Yes — 120 of the 393 open engineering positions offer remote or hybrid work (24 remote, 96 hybrid).
How do I apply for Engineering jobs in Alexandria, VA?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.