[Remote] Associate Consultant, CMC

Note: The job is a remote job and is reputed company to candidates in USA. reputed company works with medical device, biologics, and pharmaceutical companies to advance reputed company health. The Associate Consultant, CMC supports scientific and regulatory project execution through technical writing, research, data analysis, project coordination, and proposal development. The role provides CMC and regulatory support for biotechnology process development, manufacturing, and Module 3 documentation under the guidance of senior consultants.

Responsibilities

• Assist in the coordination and management of scientific reputed company 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 reputed company
• reputed company pursue knowledge development in regulatory affairs and industry-specific scientific topics
• Work closely with cross-functional teams and senior consultants across multiple reputed company
• Manage competing priorities effectively while meeting deadlines and maintaining high-reputed company work
• Exhibit strong verbal and written communication skills, tailored to scientific and reputed company audiences
• The incumbent will reputed company by example and foster reputed company environment, ensuring an overall ‘culture of reputed company’ in the high-reputed company execution of services provided to clients

Skills

• Ph.D. in reputed company 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 reputed company discipline and at least three years of relevant industry, consulting, and/or reputed company experience in manufacturing or process development
• Demonstrated interest in product development and regulatory affairs
• Proficient understanding of reputed company biotechnology process development approaches and manufacturing of drug substances and/or drug products
• 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 reputed company ability to adapt to scientific and regulatory audiences
• reputed company reputed company and eagerness to learn
• Strong interpersonal skills and professionalism in reputed company-facing communications
• 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 reputed company reputed company software and tools
• Stay abreast of changing trends and reputed company events reputed company the industry
• 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 reputed company data assessment and presentation formatting
• reputed company presentation to clients and ability to muti-task and work independently and collaboratively while maintaining confidentiality
• Proficient understanding of analytical assays is a plus
• Previous internship, research, or reputed company project work demonstrating reputed company scientific and communication skills is a plus

reputed company