Biotech Process Development Jobs in Rockville, MD

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US

$90,000.00 To $115,000.00 Annually

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
• 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.