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 s…
Skills: Companion Diagnostics, Cell Therapy Assays, FDA Regulatory Compliance, ISO 13485, ISO 15189
Position Summary: The Executive Director / Site Head of Precision for Medicine (located onsite in Frederick, MD) will be responsible to oversee the laboratory operations across 3 different functional groups in Frederick,…
Position Summary: The Executive Director / Site Head of Precision for Medicine (located onsite in Frederick, MD) will be responsible to oversee the laboratory operations across 3 different functional groups in Frederick,…
Skills: Laboratory Operations, FDA Compliance, IVDR, ISO 13485, ISO 15189
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 s…
Skills: Companion Diagnostics, Cell Therapy Assays, FDA Regulatory Compliance, ISO 13485, ISO 15189
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Job DetailsJob Location: Frederick, MDPosition Type: PRNSalary Range: $40.00 - $43.00 HourlyPRN Home Infusion Are you interested in working with Home Care Agency? Are you looking for a PRN position in your area? Please C…
We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and…
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SILVERADO FREDERICK HIRING EVENT! We want to meet you! On the spot job offers! DATE: Monday, September 28th LOCATION: 8401 Gas House Pike, Frederick, MD 21701 TIME: 11am - 5pm Open Positions: Certified Nursing Assistant(…
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$203k–$305k/yr
Full-time
postgraduate degree
Discretionary Annual Bonus, Health Insurance, Retirement Savings Benefits, Life Insurance, Disability Benefits, Parental Leave
Posted 22h ago
~40 hrs/week
Responsibilities
Oversee laboratory activities for commercially approved and developmental companion diagnostics, focusing on cell therapy assays. Lead design, validation, and regulatory compliance efforts while mentoring staff and managing client communications.
Requirements
Requires a PhD in Immunology or a related field with at least 8 years of relevant experience, including 5 years of leadership. Must have deep expertise in FDA guidance for companion diagnostics and experience with cell-based assays in regulated environments.
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
Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
Reasonable estimate of the current range
$203,200—$304,800 USD
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.
We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market. It involves utilizing technology, data, and human expertise. It is a big challenge that requires diverse talents. Our model involves both nurturing and investing organically and acquiring capabilities that we do not have but critically need. Our core executive team is anchored to this model, building life science services that address fundamental changes in healthcare that are necessary for health and outcomes improvement.
Offices: 2 Bethesda Metro Center, Suite 850, Bethesda, Maryland 20814, US
Health CareBiotechnologyMedicalPrecision MedicinePharmaceuticalBiotech & PharmaceuticalsPharmaceutical and biotechnology
How many Healthcare jobs are open in Frederick, MD right now?
There are currently 241 open healthcare positions in Frederick, MD listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Frederick, MD?
Companies currently hiring include CVS Health, Goldbelt Glacier Health Services, Kite Pharma, Precision Medicine Group, Project Farma (PF), among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Frederick, MD?
Yes — 22 of the 241 open healthcare positions offer remote or hybrid work (8 remote, 14 hybrid).
How do I apply for Healthcare jobs in Frederick, MD?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.