Join the SciLucent Team

SciLucent encourages scientific and regulatory professionals to contact us regarding employment opportunities. If you do not see any positions listed below, we currently are not actively recruiting for any positions, however, we always welcome inquiries, and resumes submitted will be considered for upcoming open positions.

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 mid-level experienced scientific professional with a strong CMC Quality Assurance 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 Quality Assurance oversight of client CMC development programs, including interfacing with vendors (CMOs, etc.), review/approval of GMP documentation, lot dispositioning, maintenance of CMC documents, etc.
  • Maintain vendor regulatory compliance documentation to ensure compliance of contract service  and material  suppliers
  • Execute GMP vendor qualification audits and mock-PAIs/PLIs.
  • Develop and maintain stage-appropriate quality systems on behalf of clients to meet all regulatory requirements for development and commercial activities.
  • Create and review Standard Operating Procedures.
  • Lead investigations and prepare metrics to support Quality System Management Reviews.
  • Assure compliance to specifications on raw materials and manufactured goods.
  • Interact efficiently with managers and other functional groups to identify issues.

The ideal candidate will have the following:

  • Bachelor’s degree, if possible in a scientific field (e.g., biology, chemistry, biochemistry, etc.), is required.
  • Consulting experience and RQAP certification are desired.
  • A minimum of 6-8 years in the pharmaceutical/biotechnology industry and/or consulting with at least 4 years in Quality Assurance relating to the oversight of CMC development
  • Excellent understanding of pharmaceutical regulations especially experience with cGMPs and 21 CFR Part 11 compliance in terms of investigational and commercial products.
  • Excellent written and verbal communication skills
  • Demonstrated organizational and project management skills
  • Strong computer skills (e.g. Microsoft Word, Excel, PowerPoint, etc.)
  • Ability to work independently and within a group setting and to interact effectively with different functional areas.
  • Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.

Both local and remote applicants will be considered and are encouraged to apply. We offer a congenial work environment, the opportunity to work with knowledgeable consultants, a competitive salary, flexible benefits, profit sharing, and a tremendous opportunity for growth.

Please send a resume and cover letter to career@scilucent.com.  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.

SciLucent, Inc., an independent Northern Virginia-based scientific consulting firm is seeking and experienced and seasoned Regulatory Toxicologist to join our multidisciplinary consulting team.  The individual will work within the Nonclinical Safety & Development group and provide support to project teams and clients to develop and execute strategic and integrated nonclinical development programs for drugs, biologics, devices, and combination products in multiple therapeutic areas.  The successful applicant will be able to work in a team environment and provide expert scientific and regulatory services while requiring minimal supervision for primary job functions and responsibilities.

Job Requirements:

  • MS degree in toxicology or a related and relevant scientific field
  • 10 or more years experience working in nonclinical development, toxicology, and/or veterinary medicine in the pharmaceutical, biotechnology, and/or contract service industries
  • Prior experience and knowledge in working with Contract Research Organizations (CRO)
  • Must possess current knowledge and expertise in regulated drug development processes
  • Track record of successfully authoring quality nonclinical regulatory documents
  • Knowledgeable in regulatory guidance documents, precedents and GLP regulations
  • Excellent communication skills and ability to effectively address scientific and regulatory questions under pressure
  • Strong sense of teamwork and demonstrated experience working with project teams, clients and regulatory personnel
  • Must be detail-oriented, with an ability to think critically and innovatively
  • Must have a client service minded attitude and be able to travel (when restrictions on business travel are eased)

Essential Duties and Responsibilities:

The candidate will devise and execute integrated nonclinical development strategies to support the development activities of drugs, biologics, devices, and combination products.  Job responsibilities include:

  • Advise, guide, and design integrated national and international nonclinical drug development strategies for our clients
  • Provide oversight and management of program outsourcing activities
  • Review, analyze, and interpret scientific data, and effectively communicate data interpretation to project teams, clients, and regulatory agencies
  • Author and/or critically review nonclinical submission packages for scientific content and quality
  • Act as nonclinical representative for Agency interactions and meetings
  • Conduct scientific assessments (e.g., gap analysis, safety assessments)

Please send a cover letter and curriculum vitae or resume to career@scilucent.com.

Both local and remote applicants will be considered and are encouraged to apply. We offer a collegial work environment, the opportunity to work with knowledgeable consultants, a competitive salary, flexible benefits, retirement plan, generous paid time off plan, profit sharing, and a tremendous opportunity for growth.

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

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 mid-level experienced 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 strategic 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 that 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 regulatory CMC representative on project teams to ensure that 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.
  • Provide mentorship to internal team members through sharing of information on regulatory CMC issues.

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 6-8 years in the pharmaceutical/biotechnology industry and/or consulting with at least 4 years in CMC Regulatory Affairs.
  • Good understanding and experience with current GMPs and regulatory expectations for investigational and commercial products.
  • Experience with CTD format and content.
  • Ability to work independently and within a group setting and to interact effectively with different functional areas.
  • Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
  • Strong computer skills using MS Word, Excel, PowerPoint.

Both local and remote applicants will be considered and are encouraged to apply. We offer a congenial work environment, the opportunity to work with knowledgeable consultants, a competitive salary, flexible benefits, profit sharing, and a tremendous opportunity for growth.

Please send a resume and cover letter to career@scilucent.com.  Applications without cover letters will not be reviewed.  Salary is based on relevant experience.

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.

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 an enthusiastic, adaptable, self-motivated individual with excellent oral and written English communication skills for this entry-level position with our Nonclinical team.

Responsibilities include:

  • Perform data and editorial review of scientific documents, including nonclinical reports and regulatory submissions;
  • Assist in the tracking and maintenance of nonclinical files, and databases;
  • Support staff toxicologists and project teams;
  • Assist with requests for quotation for nonclinical programs;
  • Author nonclinical documents including nonclinical sections of regulatory submissions;
  • Provide support for internal nonclinical operations, as needed.

Minimum requirements include a Bachelor’s degree in a relevant scientific discipline (e.g., toxicology, biology, etc.), strong attention to detail, excellent written and verbal communication skills, highly proficient with Microsoft Office products, ability to balance multiple tasks to meet priorities and timelines, and demonstrated experience working in a team environment..

We offer a congenial work environment, the opportunity to work with knowledgeable consultants in multidisciplinary teams providing services in the business of drug development, a competitive salary, flexible benefits, profit sharing, and a great opportunity for growth.

Please send a resume and cover letter to career@scilucent.com and reference NSD Associate on documents submitted.  Applications without cover letters will not be reviewed.

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

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 an enthusiastic, adaptable, self-motivated individual with excellent oral and written English communication skills for this entry-level position.

Responsibilities include:

  • Manage CRM tool and accurately input all required client information
  • With assistance from practice lines, draft and coordinate SOW text and budget estimates
  • Manage and coordinate the executed contracting process for all functional areas of the company
  • Manage contract milestone activities
  • Identify, communicate, and resolve issues as they arise
  • Assist project managers in adhering to the terms of the SOW
  • Lead implementation of marketing plan and social media posting
  • Draft tracking systems for action items and other items as necessary
  • Maintain up-to-date project reporting
  • Maintain compliance to the contracts (MSA, NDA, CDA, SOW)
  • Act as a liaison and coordinator amongst functional areas and project managers
  • Assist with preparing and maintaining company contracting templates
  • Prepare reports as directed by the management team

Minimum requirements include a Bachelor’s in a relevant discipline and at least 2 years of experience in administration or contracting.  Also qualified candidates will possess excellent attention to detail skills, negotiation, customer service, writing, and computer skills, ability to balance multiple tasks and timelines, and demonstrated experience working in a team environment.  Experience in marketing and the drug development field are preferred but not required.

This is an entry-level position located in our Herndon, VA office, however, we will consider remote locations depending on experience.  We offer a congenial work environment, the opportunity to work with knowledgeable consultants in multidisciplinary teams and learn the business of drug development, a competitive salary, flexible benefits, profit sharing, and a tremendous opportunity for growth.

Please send a writing sample, resume, and cover letter to career@scilucent.com.  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.

Send a cover letter and CV or resume

SciLucent offers a congenial work environment, the opportunity to work with knowledgeable consultants in multidisciplinary teams and learn the business of healthcare product development, a competitive salary, flexible benefits, profit sharing, and a tremendous opportunity for growth.

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    SciLucent is committed to equal employment opportunity as a sound business practice.  Employment practices will not be influenced or affected by an applicant’s or employee’s race, color, religion, sex, national origin, age, disability, sexual orientation, marital status, or any characteristic protected by law.  Please see the two links below for important notices for job applicants and employees:

    Employee Polygraph Protection Act:  https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
    Equal Employment Opportunity Commission:  https://www.eeoc.gov/employers/upload/poster_screen_reader_optimized.pdf

    For other information regarding employment:

    Human Resources
    SciLucent
    585 Grove Street, Suite 300
    Herndon, VA  20170
    career@scilucent.com