Careers

SciLucent, Inc., a Northern Virginia-based scientific consulting firm providing technical, regulatory, and product development services to developers, manufacturers, and marketers of pharmaceuticals and medical devices, seeks a scientific professional with a strong CMC Regulatory Affairs background to join our team of experienced professional consultants.  We are looking for an enthusiastic, adaptable, self-motivated individual with excellent communication skills.

Responsibilities of the position include:

• Provide CMC regulatory guidance to clients including planning, authoring, and managing the production of clear and persuasive CMC-related regulatory submissions for pharmaceuticals, biologics, and combination products such as INDs, NDAs/BLAs, meeting requests, and meeting packages.
• Develop, manage, and ensure overall project timelines support the coordination and preparation of timely submissions.
• Communicate and coordinate with relevant internal and external clients and team members to identify and ensure the preparation of required CMC documentation and data needed for regulatory submissions.
• Act as CMC regulatory representative on project teams to ensure development activities support and comply with the relevant regulatory requirements.
• Maintain up-to-date working knowledge of relevant regulatory regulations, guidance, and the current regulatory environment.

The ideal candidate will have the following:

• Bachelor’s degree preferably in a scientific field (e.g., biology, chemistry, biochemistry, etc.). An advanced degree is desirable.
• A minimum of 2 years in the pharmaceutical/biotechnology industry and/or consulting.
• Good understanding and experience with current GMPs and regulatory expectations for investigational and commercial products.
• Knowledge of biologic product development is desired.
• Experience with CTD format and authoring Module 3 content.
• Ability to work independently and within a group setting and to interact effectively with different functional areas.
• Ability to independently work on multiple projects and to effectively manage time.
• Good communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
• Working knowledge of MS Word, Excel, PowerPoint and the ability to acquire knowledge of job specific software.

Both local and remote applicants will be considered and are encouraged to apply. Our most valuable resource is our people.  We hire intelligent, creative, passionate professionals with a strong desire to learn.  At our core – collaboration, camaraderie, growth, and collective hard work without egos.  Our culture is one that encourages, supports, and celebrates our colleagues!  We offer a congenial, supportive, and flexible work environment, the opportunity to work with knowledgeable consultants, and the ability to develop a tremendous amount of knowledge and expertise across many stages and areas of healthcare product development.  Additionally, we offer the following benefits:  medical, dental, vision, FSAs, HSA, EAP, Life insurance, disability insurance, 401K with company contribution, ESOP, Holidays, and PTO.  The base salary range for this position is $50,000 – $90,000.  Any offered salary is based on internal equity, internal salary ranges, market data/ranges, applicant’s skills and prior relevant experience, certain degrees, and certifications.

Please send a resume and cover letter to [email protected].  Applications without cover letters will not be reviewed.

SciLucent is an equal opportunity employer.  We thank all applicants for their efforts in applying for our open position; while all applicants will be considered, only candidates selected for interviews will be contacted.