Principal Scientist, Clinical Operations

novative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://https://www.jnj.com

Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Pharmacokinetics & Pharmacometrics
Job Category:
Scientific/Technology
All Job Posting Locations:
Spring House, Pennsylvania, United States of America
Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Principal Scientist, Clinical Operations to be in Spring House, PA.

Purpose:

This is a clinical operations support position within the Bioanalytical Discovery and Development Sciences (BDDS). We work with internal bioanalytical groups and external partners to ensure the completion of all activities related to clinical study data deliveries and sample management. We work to support all therapeutic areas within Johnson & Johnson, spanning nonclinical studies to post-market clinical development.

You will be responsible for:

• Serve as a point of contact within the Trial & Laboratory Operations group, serving as primary liaison to partnering groups, as well as a representative on project teams as required.

• Ensure accurate receipt, shipment, handling and storage of frozen biological specimen samples in support of non-clinical and clinical studies.

• Lead a team to support all aspects of the receipt and inventory of frozen laboratory samples sent from central laboratory or contract laboratory into freezers using Laboratory Information Management Systems (LIMS) to track sample chain of custody.

• Ensure samples are provided to scientists for analysis using LIMS to meet study timelines.

• Support management of the sample storage assets (freezers, chart recorders, handheld scanners, etc.), as well as the freezer inventory system and other sample management activities with contractors.

• Review and provide comments on the technical documents (protocols, statement of works and lab manuals) from internal groups, Central Laboratories, and outsourced bioanalytical laboratories for studies where the department conducts analyses, receives results, or has oversight of an external laboratory.

• Create data transfer agreements per departmental guidelines

• Review sample and data flow specifications documents from internal groups and Central Laboratories for studies.

• Provide support with acquisition, storage, and disposition of clinical study samples.

• Define studies in LIMS for clinical studies so that samples can be receipted and analyzed.

• Close collaboration with internal and external partnering groups, such as central labs and cross functional teams, as needed.

Qualifications / Requirements:

Education:

• Minimum of a PhD in Biology, Chemistry, Biochemistry or a related scientific field with up to 4 years' experience OR Master's with at least 6 years of experience in a laboratory setting OR Bachelors with at least 8 years of experience in a laboratory setting is required.

Required:

• Experience mentoring, training or leading junior colleagues in a pharmaceutical or CRO group is required

• Excellent communication, interpersonal skills, networking skills, a high level of organizational ability, and attention to detail is required

• Sample management experience is required. Experience reviewing lab-based technical documents (e.g., Protocols, Statements of Work, and/or Lab Manuals) is required.

• Experience working in database systems (e.g., Watson LIMS, LabVantage LIMS, etc.) is required.

• Strong expertise in areas of GLP/GCP is required.

Preferred:

• Experience with sample reconciliation and data management is preferred

• Ability to identify problems and process improvement opportunities and drives resolution is preferred. Knowledge of overall drug discovery and development is preferred

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

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