Job Description

Location: Preference for candidates local to Princeton, NJ or Rockville, MD . Remote considered for the right candidate (must work East Coast business hours).
Position Summary
We are seeking a Data Scientist Consultant to support analytical and stability activities for developmental, clinical, and commercial pharmaceutical products. This role will focus on ensuring compliance with GxP requirements, managing analytical data, and providing statistical insights to support regulatory submissions and business decision-making.
Key Responsibilities
Review analytical data (including raw data) for accuracy and compliance with internal and GxP requirements.
Initiate and monitor stability studies for developmental, clinical, and commercial pharmaceutical products tested by contract labs.
Review, enter, and maintain stability data for pharmaceutical products.
Create and manage studies in LIMS for multiple projects.
Enter or review sample test result data in LIMS.
Assist with technical investigations; enter deviations and investigations into Trackwise.
Maintain and manage analytical testing documentation (protocols, reports, data) in compliance with GDP and data integrity standards.
Prepare stability reports and summaries for INDs, NDAs, and regulatory submissions, ensuring accuracy and adherence to regulatory requirements.
Apply descriptive statistics to organize and summarize data.
Use statistical analysis techniques to identify patterns and trends based on project needs.
Generate graphs, profiles, and reports of testing/stability data and statistical analysis.
Collaborate with project teams to support informed business decisions through data-driven insights.
Qualifications
Required:
Bachelor’s degree in Chemistry or related science.
5+ years of experience in a GxP environment focused on analytical laboratory testing of pharmaceuticals.
Familiarity with GMP environments and analytical laboratory testing methods (HPLC, Dissolution, etc.).
Strong communication and interpersonal skills; ability to collaborate with internal and external stakeholders.
Proficiency in MS Office (Excel, Word, PowerPoint).
Demonstrated experience with data review.
Excellent oral and written communication skills.
Nice To Have
Experience with electronic document management systems (Veeva, CARA, etc.).
Experience with investigation software (Trackwise preferred).
Experience with LIMS (Laboratory Information Management Systems).
Strong planning, organizational, and coordination skills.

Job Tags

Contract work, Local area, Remote work,

Similar Jobs

Bashas'

Starbucks Team Lead Job at Bashas'

...Position Purpose: The Starbucks Team Lead creates the Starbucks Experience for Bashas' customers by providing customers with prompt... ...endorsement upon request from HR. # You may be asked to accept a part-time position if that is the only position available # Rehires...

Advanced Medical Supply

Sales Representative - Medical Equipment Job at Advanced Medical Supply

...Medical Sales Territory Representative Medical Equipment Are you looking for a lucrative career where you can make a big difference in the health of others. Does a patient-focused, innovation-driven company that will inspire you and support your Medicall Sales Rep...

Starbucks

Starbucks Cashier Job at Starbucks

...Cashiers / Baristas Come see what Starbucks is brewing! A great career is brewing Competitive... ...schedule Health insurance Paid time off Vision insurance Referral... ...applicants please apply! Job Types: Full-time, Part-time Our story begins in 1971 along...

Eastridge

Billing Specialist Job at Eastridge

...Billing Specialist Department: Billing and Accounts Receivable Job Number: 100368 Locations: New York, Los Angeles, Boston... ...issues when necessary. Collaborate with collections and accounts payable to reconcile accounts and ensure full cost recovery. Provide...

University of Massachusetts Boston

Senior Proposal Writer Job at University of Massachusetts Boston

...Massachusetts Boston seeks a seasoned professional to join its dynamic and growing development and alumni engagement team.The Senior Proposal Writer for Principal & Leadership Gifts is a senior level fundraising position reporting to the Assistant Vice Chancellor for...

Data Scientist Consultant Job at Advanced Clinical, Rockville, MD

RSt4dWIyVVFDWDRtV3Jhb3cyTlordWxweXc9PQ==