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 FDA-regulated products, is looking to expand its regulatory affairs team with an experienced scientific consultant with strong interpersonal skills.  We are looking for an enthusiastic, adaptable, self-motivated individual with excellent communication skills and demonstrated project management ability for this position.

Responsibilities

  • Maintain project trackers to meet deliverable due dates
  • Effectively lead communications with clients, healthcare agencies, and project team
  • Lead and guide cross-functional project team professionals
  • Manage the implementation of scientific/regulatory strategies and associated project timelines
  • Author regulatory documents and lead teams preparing FDA submissions
  • Draft and review regulatory documents for scientific content, quality, and messaging
  • Assist a project team in preparing for FDA meetings
  • Provide support and guidance to clients and ensure that regulatory documentation is accurate and compliant with relevant regulations, guidelines, and industry standards
  • Participate in business development activities

Requirements

  • Minimum of a Bachelor’s degree in a relevant scientific discipline; an advanced degree in science and/or regulatory affairs experience is preferred
  • A minimum of 3 years’ experience as a scientific/regulatory professional in the pharmaceutical/biotech industry; consulting experience in regulatory affairs and experience across a variety of therapeutic areas is desirable
  • Strong experience leading projects
  • Knowledge of basic FDA principles
  • Excellent communication skills and client management skills
  • Pharmaceutical development, pre-approval regulatory experience

Skills and Capabilities

  • Strong project management, communication, and interpersonal skills
  • Ability to interpret scientific information
  • Ability to build and maintain client relationships
  • Familiarity with regulatory affairs in the drug development industry
  • Fluency in vocal and written English

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 its 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, a competitive salary, flexible benefits, profit sharing, and the ability to develop a tremendous amount of knowledge and expertise across many stages and areas of healthcare product development.

Please send a resume and cover letter—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. (www.scilucent.com), 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.
  • 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)

Both local and remote applicants will be considered and are encouraged to apply. We are a small company and at this time are unable to sponsor candidates for employment.

Our most valuable resource is our people.  We hire intelligent, creative, passionate professionals with a strong desire to learn.  At its 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, a competitive salary, flexible benefits, profit sharing.

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

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 nonclinical study monitoring background to join our team of experienced professional toxicology consultants.  We are looking for an enthusiastic, adaptable, self-motivated individual with excellent communication skills.

Responsibilities of the position include:

  • Manage all aspects of outsourced nonclinical studies including study design, competitive bidding, pre-study activities, study monitoring, data and report review.
  • Monitor the studies including site visits, as needed, to ensure scientific, regulatory, compliance and animal welfare regulations expectations are met and quality reports are delivered on agreed upon timeline.
  • Provide technical and scientific nonclinical study advice for a wide range of study designs, route of administration, and species commonly used in drug development.
  • Provide regulatory toxicology support to clients.
  • Author reports and/or regulatory documents as needed.
  • Interact with clients and vendors.
  • Provide scientific and innovative advice to internal and external parties.
  • Participate in business development activities.

The ideal candidate will have the following:

  • Bachelor’s degree, in a scientific field (e.g., biology, chemistry, biochemistry, etc.), is required.
  • Prior experience in Study Directorship or coordination in a Contract Research Organization (CRO) is highly desired.
  • A minimum of 4 years in the pharmaceutical/biotechnology industry, CRO, and/or consulting with significant study monitoring experience.
  • Good understanding of technical study conduct, study design, procedures, and documentation practices and regulatory requirements.
  • Proven knowledge of Good Laboratory Practices (GLP).
  • 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.
  • Excellent communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
  • Available to travel 30 – 70% of the time.

Both local and remote applicants will be considered and are encouraged to apply. We are a small company and at this time are unable to sponsor candidates for employment.  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.

ASSOCIATE – CHEMISTRY, MANUFACTURING, AND CONTROLS (CMC) AND QUALITY

SciLucent, Inc. is a Northern Virginia-based scientific consulting firm providing technical, regulatory, and product development services to developers, manufacturers, and marketers of FDA-regulated products.  We are expanding our scientific consulting team with enthusiastic, adaptable, self-motivated individuals with excellent oral and written English communication skills for this entry-level position.

Responsibilities include:

  • Research and apply current regulatory expectations relating to manufacturing, analytical methods, stability, and supply chain controls.
  • Assist in managing CMC development projects.
  • Author/compile CMC sections of regulatory submissions.
  • Assist in the selection process for contract manufacturing/laboratory vendors to support client programs.
  • Assist in the creation and execution of phase-appropriate Pharmaceutical Quality Management Systems to comply with applicable cGMPs.
  • Assist in the preparation of study protocols/reports, specifications, analytical methods, batch records, and other technical documents supporting CMC development.
  • Review, assess, and/or analyze CMC development data/information to draw conclusions and/or formulate strategies to progress product development.
  • Process, publish, and review electronic regulatory submissions in eCTD format.
  • Perform quality control review of technical aspects of regulatory submissions and critical review of submission components to ensure technical completeness of submissions.
  • Provide support to colleagues in the other SciLucent practice areas including clinical, nonclinical, regulatory, and quality.

Minimum requirements include a Bachelor’s degree in a relevant scientific discipline (e.g. chemistry, biochemistry, biology etc.), strong attention to detail, excellent writing, computer, and presentation skills, ability to balance multiple tasks to meet priorities and timelines, and demonstrated experience working in a team environment.  We desire folks that have inherent curiosity and internal drive to provide excellent service to clients.  Experience in the regulatory field is preferred, but not required.

Our most valuable resource is our people.  We hire intelligent, creative, passionate professionals with a strong desire to learn.  At its 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, a competitive salary, flexible benefits, and the ability to develop a tremendous amount of knowledge and expertise across many stages and areas of healthcare product development.

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

ASSOCIATE – CHEMISTRY, MANUFACTURING, AND CONTROLS (CMC) REGULATORY  AFFAIRS

SciLucent, Inc. is a Northern Virginia-based scientific consulting firm providing technical, regulatory, and product development services to developers, manufacturers, and marketers of FDA-regulated products.  We are expanding our scientific consulting team with enthusiastic, adaptable, self-motivated individuals with excellent oral and written English communication skills for this entry-level position.

Responsibilities include:

  • Author/compile CMC sections of regulatory submissions.
  • Research and apply current regulatory expectations relating to manufacturing, analytical methods, stability, and supply chain controls.
  • Assist in managing CMC development projects.
  • Assist in the selection process for contract manufacturing/laboratory vendors to support client programs.
  • Assist in the creation and execution of phase-appropriate Pharmaceutical Quality Management Systems to comply with applicable cGMPs.
  • Assist in the preparation of study protocols/reports, specifications, analytical methods, batch records, and other technical documents supporting CMC development.
  • Review, assess, and/or analyze CMC development data/information to draw conclusions and/or formulate strategies to progress product development.
  • Process, publish, and review electronic regulatory submissions in eCTD format.
  • Perform quality control review of technical aspects of regulatory submissions and critical review of submission components to ensure technical completeness of submissions.
  • Provide support to colleagues in the other SciLucent practice areas including clinical, nonclinical, regulatory, and quality.

Minimum requirements include a Bachelor’s degree in a relevant scientific discipline (e.g. biology, chemistry, biochemistry, etc.), strong attention to detail, excellent writing, computer, and presentation skills, ability to balance multiple tasks to meet priorities and timelines, and demonstrated experience working in a team environment.  We desire folks that have inherent curiosity and internal drive to provide excellent service to clients.  Experience in the regulatory field is preferred, but not required.

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, a competitive salary, flexible benefits, and the ability to develop a tremendous amount of knowledge and expertise across many stages and areas of healthcare product development.

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

ASSOCIATE – NONCLINICAL SAFETY & DEVELOPMENT (NSD) – Pharma Industry

SciLucent, Inc., a Northern Virginia-based scientific consulting firm providing technical, regulatory, and product development services to developers, manufacturers, and marketers of FDA-regulated products.  We are expanding our scientific consulting team with enthusiastic, adaptable, self-motivated individuals with excellent oral and written English communication skills for this entry-level position.

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 desire folks that have inherent curiosity and internal drive to provide excellent service to clients.  Prior experience at an in vivo laboratory or nonclinical contract research organization (CRO) preferred, but not required.  Interest in nonclinical safety and development desired.

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, a competitive salary, flexible benefits, and the ability to develop a tremendous amount of knowledge and expertise across many stages and areas of healthcare product development.

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 interest and effort in applying for our open position; while all applicants will be considered, only candidates selected for interviews will be contacted.

ASSOCIATE – CLINICAL & REGULATORY AFFAIRS — Biotech

SciLucent, Inc., a Northern Virginia-based scientific consulting firm providing technical, regulatory, and product development services to developers, manufacturers, and marketers of FDA-regulated products.  We are expanding our scientific consulting team with enthusiastic, adaptable, self-motivated individuals with excellent oral and written English communication skills for this entry-level position.

Responsibilities include:

  • Assist in the preparation and compilation of clinical and regulatory documents;
  • Author clinical documents including clinical sections of regulatory submissions;
  • Perform quality control review of technical aspects of clinical development documents and regulatory submissions with critical review of submissions to ensure technical completeness;
  • Process, publish, and review electronic regulatory submissions in eCTD format; and
  • Provide support and document retrieval, review, and analysis across the fields of toxicology, chemistry, and medicine.

Minimum requirements include a Bachelor’s in a relevant scientific discipline (e.g., toxicology, biology, chemistry, biochemistry, etc.), strong attention to detail, excellent writing and computer skills, ability to balance multiple tasks and timelines, and demonstrated experience working in a team environment.  We desire folks that have inherent curiosity and internal drive to provide excellent service to clients.  Experience in the clinical or regulatory field preferred but not required.

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, a competitive salary, flexible benefits, and the ability to develop a tremendous amount of knowledge and expertise across many stages and areas of healthcare product development.

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