Top 21 Director of science Jobs in Frederick, Md

Senior Director, Companion Diagnostics
Precision Medicine Group —Frederick, MD
- $203,200 - $304,800 a year
- Online Application
- Microsoft Word
- Microsoft Excel
- 11+ years
Senior Scientific Director, Flow Cytometry
Precision Medicine Group —Frederick, MD
- $203,200 - $304,800 a year
- Extended hours
- 18 years or older
- English
- Ability to lift 50 pounds
6d
Associate Director, AS&T Lifecycle Management (Chemical Method Expert)
BioNTech AG —Gaithersburg, MD
- $146,300 - $234,100 a year
- Full-time
- Senior level
- Commercial
Associate Director, AS&T Lifecycle Management (Biological Method Expert)
BioNTech AG —Gaithersburg, MD
- $146,300 - $234,100 a year
- Full-time
- Senior level
- Commercial
Director/Senior Director, Biostatistical Programming
Kaztronix —Gaithersburg, MD
- Computer Science
- 11+ years
- Mentoring
Quick Apply
Director, Toxicology
BASI GAITHERSBURG LLC —Gaithersburg, MD
- Weekends as needed
- Doctoral degree
- 5 years
- Mentoring
- Paid parental leave
- Disability insurance
Quick Apply
Director, Computational Science Research and Partnerships Division
US Department of Energy Headquarters —Germantown, MD
- $199,172 - $228,000 a year
- Online Application
- Background check
- Computer science
- Computer Science
13d
Senior Director, Companion Diagnostics
Precision for Medicine —Frederick, MD
- $203,200 - $304,800 a year
- Online Application
- Microsoft Word
- Microsoft Excel
- 11+ years
Quick Apply
Executive Director, Head of Biometrics, Infectious Disease
AstraZeneca —Gaithersburg, MD
- $278,568 - $417,852 a year
- 5 years
- Office
- Math
- Health insurance
- Dental insurance
Director, Bioanalytical Laboratory
Meso Scale Diagnostics, LLC. —Gaithersburg, MD
- $174,100 - $272,100 a year
- Master's degree
- Analysis skills
- Doctor of Philosophy
- Paid parental leave
- AD&D insurance
Quick Apply
8d
Senior Scientific Director, Flow Cytometry
Precision for Medicine —Frederick, MD
- $203,200 - $304,800 a year
- Extended hours
- 18 years or older
- English
- Ability to lift 50 pounds
Quick Apply
6d
Executive Director, Head of Cell Therapy Non-Clinical Safety Lead, Cell Therapy Translational and Safety Sciences.
AstraZeneca —Gaithersburg, MD
- $264,258.40 - $396,387.60 a year
- Office
- Doctor of Philosophy
- Recruiting
- Health insurance
- Dental insurance
8d
Clinical Research & Development Associate Director
AstraZeneca —Gaithersburg, MD
- Medicine
- English
- Doctor of Philosophy
3d
Clinical Research & Development Director
AstraZeneca —Gaithersburg, MD
- Office
- Master's degree
- Continuous improvement
3d
Clinical Research & Development Associate Director Myositis/Immunology
AstraZeneca —Gaithersburg, MD
- English
- Master's degree
- Doctor of Philosophy
3d
Director, Global Pharmacovigilance / Safety Operations
Immunocore —Gaithersburg, MD
- $157,500 - $262,500 a year
- Full-time
- Nursing
- 5 years
- Analysis skills
Head of Clinical Operations ( On site role)
Precigen, Inc —Germantown, MD
- Full-time
- Microsoft Word
- Medicine
- Bachelor's degree
Quick Apply
Senior Director, Global Pharmacovigilance (Safety Physician)
Immunocore —Gaithersburg, MD
- $187,500 - $312,000 a year
- Full-time
- Medicine
- BC/BE
- Doctor of Philosophy
Durational Field Director
r c goodwin and associates, inc —Frederick, MD
- $18 - $21 an hour
- Mid-level
- 3 years
- Master's degree
Quick Apply

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Senior Scientific Director, Flow Cytometry
Precision Medicine Group —Frederick, MD
PhD. in life sciences or relevant field in life sciences and at least 18 years of full-time relevant laboratory experience or equivalent combination of…
$203,200 - $304,800 a year
6d
Senior Scientific Director, Flow Cytometry
Precision for Medicine —Frederick, MD
PhD in life sciences or relevant field in life sciences and at least 18 years of full-time relevant laboratory experience or equivalent combination of education…
$203,200 - $304,800 a year
Quick Apply
6d

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Senior Director, Companion Diagnostics

Precision Medicine Group -
Frederick, MD

Apply Now

Job Details

$203,200 - $304,800 a year

Qualifications

Microsoft Word
Customer communication
Microsoft Excel
Presentation software
ISO standards
CAP guidelines
English
In vitro studies
Assay development
Doctor of Philosophy
CLIA regulations
Biological analysis
Design controls
Biomedical regulatory compliance
Verification of laboratory test methods
Research regulatory compliance
Clinical quality assurance standards
Legal compliance
Validation design
FDA regulations
Senior leadership

Full Job Description

Position Summary:

The Senior Director, Companion Diagnostics (sitting onsite in Frederick, MD) will be responsible for overseeing the laboratory activities for teams focused on supporting both commercially approved CDx sample analysis as well as CDx programs in development. They will use their scientific expertise to lead design, development and validation efforts for cell therapy assays to support multiple fast-paced clinical and non-clinical studies for clients engaged in cutting-edge research. A critical requirement is deep current knowledge of FDA guidance documents and requirements, specifically relevant to companion diagnostics, along with the ability to put these requirements into practice developing robust assays that easily pass FDA scrutiny. Experience with developing and managing programs following FDA. ISO 13485 and 15189 principles of design control, understanding of both CLIA and CLSI validation requirements, and assay execution of both cell-based and non-cell-based assays is required.

As the Senior Director, Companion Diagnostic, this person will train and mentor staff to ensure scientific rigor and regulatory compliance to GxP, CLSI, CLIA/CAP and State DOH (eg.,NY, CA, RI, PA) use their expertise to guide assay development and troubleshooting. The position requires direct experience in all aspects of companion diagnostics, large molecule regulated bioanalysis and working knowledge of industry best practices. The person will work closely with QA and Regulatory to ensure regulatory compliance and work with project managers to ensure laboratory delivery and timely and efficient client communication. Lastly, the ideal candidate will have had experience with hosting and/ or participating in regulatory audits.

Essential functions of the job include but are not limited to:

Mentor and lead all companion diagnostic teams to ensure high quality compliant data.
Works with Lab Director to identify and provide continuing education to laboratory testing personnel that is relevant to laboratory practices
Direct staff to ensure consistent scientific standards and compliance with Precision procedures and regulatory expectations on all projects
Monitors and provides metrics, KPIs to senior leadership which includes but is not limited to: quality metrics, TAT, assay failure rate, volumes and revenue.
Monitors inventory (client and precision inventory) and lab supplies; ensures staff perform regular inventory counts and updates the inventory software system.
Ensure lab is run efficiently, reviews processes, SOPs and implements improvements regarding operational excellence.
Is main contact for clients regarding scientific updates and manage client expectations for all projects within the team. Provides verbal or written updates as necessary.
Participate actively in the companion diagnostics community to ensure Precision is fully aware of any and all relevant guidance with the Cell & Gene Therapy Industry
Participate in product (device) development, commercialization and life cycle management
Have good working knowledge of execution of assay according to ISO 13485 Design Control procedures, ISO 15189 Medical Laboratories as well as knowledge of CLIA and CLSI requirements for assay validation. Coordination of cross functional activities between Precision business units and among various subject matter experts to increase operational efficiencies and streamline deliverables to clients
Review and approve development and validation study protocols and reports to meet CAP/CLIA and CLSI requirements
Oversee the execution of all work to ensure the team understands and is meeting study compliance for all work performed, including study budget requirements.
Responsible for trouble shooting and correcting all scientific issues/problems within the team
Prepare/review/writes critical documents including protocols, reports, and SOPs
Work collaboratively with other technical teams in resource sharing and providing technical expertise
Maintain and support safe lab practices and environment
Carry out other duties/projects as assigned

Qualifications:

Minimum Required:

PhD in Immunology or related field
18+ years' relevant experience
12+ years' leadership experience

Other Required:

Prior supervisory experience
Must have demonstrated expertise in Companion Diagnostics related to Cell & Gene Therapy regulatory guidance and industry best practice
Direct experience and knowledge in cell based assays used for supporting regulated studies
A solid understanding of current GLP, GCP or GCLP standards
Working knowledge of CAP/CLIA, CLSI and ISO 13485
Excellent communication, interpersonal, organizational and multi-tasking skills
Must be proficient with Microsoft Word, Excel, and PowerPoint
Ability to interact and function in a highly productive work environment
Ability to work independently and have good attention to detail
Must be able to read, write, speak fluently and comprehend the English language

Preferred:

Direct experience working at a CRO, Biotechnology or Pharmaceutical company.
Expertise in ELISA, MSD, Luminex, Quanterix and SPR technologies

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].

Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at [email protected] so we can investigate and take appropriate action.

Apply Now

Refine Your Search

director of science jobs in frederick, md

Senior Director, Companion Diagnostics

Senior Scientific Director, Flow Cytometry

Associate Director, AS&T Lifecycle Management (Chemical Method Expert)

Associate Director, AS&T Lifecycle Management (Biological Method Expert)

Director/Senior Director, Biostatistical Programming

Director, Toxicology

Director, Computational Science Research and Partnerships Division

Senior Director, Companion Diagnostics

Executive Director, Head of Biometrics, Infectious Disease

Director, Bioanalytical Laboratory

Senior Scientific Director, Flow Cytometry

Executive Director, Head of Cell Therapy Non-Clinical Safety Lead, Cell Therapy Translational and Safety Sciences.

Clinical Research & Development Associate Director

Clinical Research & Development Director

Clinical Research & Development Associate Director Myositis/Immunology

Director, Global Pharmacovigilance / Safety Operations

Head of Clinical Operations ( On site role)

Senior Director, Global Pharmacovigilance (Safety Physician)

Durational Field Director

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