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 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. 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 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., a Northern Virginia-based scientific consulting firm providing technical, regulatory, and product development services to developers, manufacturers, and marketers of FDA-regulated products, seeks an enthusiastic, adaptable, self-motivated individual with excellent oral and written English communication skills.

Responsibilities include:

  • Assist in managing and coordinating office facilities
  • Assist with inventory management and fixed assets
  • Manage company-wide subscriptions and services
  • Provide logistical support for meeting coordination and corporate activities
  • Provide administrative support for general office needs, projects, and onboarding new employees
  • Oversee shipping and courier support
  • Manage and acquire office supplies
  • Coordinate staff meeting needs, i.e., create and circulate agendas, record staff meeting minutes, and filing
  • Assist with accounting functions such as monthly invoice process, the accounts payable process (credit card reconciliation and receipt management), and employee expense reporting
  • Provide support to scientific and regulatory projects as requested
  • Ensure compliance with company policies and sound business practices
  • Assist in building and maintaining databases to track projects, clients, and business-to-business relationships/work exchange
  • Assist the Contracts Manager in managing the contracting process
  • Assist the Director of Human Resource
  • Provide ad hoc administrative support

Minimum requirements

  • 3+ years of experience in administration, project/office management, contracting, and/or accounting.
  • Excellent attention to detail skills, organizational, follow-through, negotiation, and customer service skills
  • Proficient with Microsoft Office Suite and Adobe software, including the ability to draft and format MS Word documents, Excel spreadsheets, etc.
  • Strong interpersonal, verbal, and written communication skills
  • Ability to balance multiple tasks and timelines
  • Demonstrated experience working in a team environment.

This position is located in our Herndon, VA office.  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 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., a Northern Virginia-based scientific consulting firm providing technical, regulatory, and product development services to developers, manufacturers, and marketers of pharmaceuticals seeks an experienced pharmaceutical/biotech Quality Assurance professional to join our team of consultants.  We are looking for an enthusiastic, adaptable, self-motivated individual with excellent communication skills.

Clinical Quality Assurance (CQA) Responsibilities of the position include:

  • Performing review and gap analysis of client’s existing quality systems and leading development and implementation of Phase-appropriate CQA activities maintaining compliance with regulatory expectations.
  • Creation and review of CQA/GCP Policies/Standard Operating Procedures (SOPs).
  • Providing CQA oversight of client development programs, audit schedules, and audit plans.
  • Leading and executing GCP audits of vendors (i.e., Clinical Research Organization’s [CROs], Phase 1 Units, Clinical Pharmacology Units (CPUs), Central and specialty laboratories, CAP/CLIA laboratories, Trial Master File, etc.), Sponsors, and/or clinical site.
  • Interfacing with clients, vendors, and other functional groups to identify quality issues.
  • Supporting and conducting pre-inspection readiness audits and supporting client’s during regulatory inspections.
  • Authoring and/or reviewing clinical and regulatory project documents including, but not limited to protocols, investigator’s brochures, clinical study reports, etc.

The ideal candidate will have the following:

  • Bachelor’s degree, in a scientific field (e.g., biology, chemistry, biochemistry, etc.), is required.
  • Previous consulting experience is preferred.
  • A minimum of 8 years in the pharmaceutical/biotechnology industry and/or consulting with at least 5 years in a CQA function.
  • Excellent understanding of pharmaceutical regulations and guidelines (GCP).
  • Experience in authoring and/or reviewing clinical and regulatory project documents including, but not limited to protocols, investigator’s brochures, clinical study reports, etc.
  • Organizational and project management skills; must be able to provide simultaneous support for ongoing and rotating projects.
  • Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
  • Strong computer skills (e.g., Microsoft Word, Excel, PowerPoint, etc.).
  • Ability to work independently and within a group setting and to interact effectively with clients and different functional areas.

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 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., 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 experienced pharmaceutical/biotech Quality Assurance professional to join our team of consultants.  We are looking for an enthusiastic, adaptable, self-motivated individual with excellent communication skills.

Responsibilities of the position include:

  • Assist clients in the provision of Quality Assurance support services and function.
  • Lead the establishment and management of Phase-appropriate, Quality Management Systems to support client development activities and maintain compliance with regulatory expectations.
  • Review and negotiation of Quality Agreements
  • Create and review Standard Operating Procedures.
  • Evaluate and support implementation of electronic QMS systems for clients (e.g., Veeva, TrackWise).
  • Provide Quality Assurance oversight of client development programs, including interfacing with vendors (CMOs, etc.).
  • Maintain vendor regulatory compliance documentation to ensure compliance of contract service and material suppliers.
  • Be able to lead and execute GMP and/or CAP/CLIA Laboratory vendor audits and the authoring of audit reports.
  • Interact efficiently with managers and other functional groups to identify issues.

The ideal candidate will have the following:

  • Bachelor’s degree in a scientific field (e.g., biology, chemistry, biochemistry, etc.), is required.
  • Previous consulting experience is strongly desired.
  • A minimum of 8-10 years in the pharmaceutical/biotechnology industry and/or consulting with at least 5 years in Quality Assurance functions
  • Excellent understanding of pharmaceutical regulations (GxP) with experience in cGMPs and 21 CFR Part 11 compliance in terms of investigational and commercial products.
  • Experience in support of CMC/GMP activities is desired, with the capability to review/approve GMP documentation (specifications, protocols, batch records, etc.), make lot dispositioning, assign retest and expiry dates to materials, etc.
  • Familiarity with electronic QMS systems is desired.
  • Must be self-directed and able to conceptualize solutions and implement them
  • Demonstrated organizational and project management skills; must be able to provide simultaneous support for ongoing and rotating projects
  • Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
  • 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.
  • Have experience managing relatively small QA teams.

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 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., 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.

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