Senior Analytical Scientist - Method Development & Validation (CDMO)Location: Cranbury, NJ (100% Onsite)
Position Type: Full-Time, Monday - Friday (9:00 AM - 5:00 PM)
Compensation: $40.00 - $48.00 / hour (Depending on experience)
Position Summary Are you a skilled Analytical Scientist looking to take on a leadership role in a fast-paced, cutting-edge environment? Medix is seeking a
Senior Analytical Scientist to join a pharmaceutical client in Cranbury, NJ.
In this role, you will split your time between analytical method development and method validation, serving as the technical lead for a critical client pipeline. You will conduct routine and non-routine testing of raw materials, bulk intermediates, and finished products, while leading a team of talented scientists and technicians. If you have a strong background in small molecule analysis (oral solid or inhalation) and thrive in a dynamic CDMO or QC lab environment, we want to hear from you.
Essential Job Functions - Method Development & Validation: Develop, evaluate, and validate analytical methods (specifically HPLC and GC) for raw materials, in-process materials, finished goods, and cleaning verifications.
- Testing & Analysis: Perform various chemical assays, dissolution testing, moisture testing (Karl Fischer), and release/stability testing.
- Team Leadership: Lead and mentor a team of analytical scientists and technicians; perform peer reviews of laboratory records and notebook pages.
- Investigations & Compliance: Lead Out-of-Specification (OOS) and Out-of-Tolerance (OOT) laboratory investigations. Ensure absolute compliance with cGMP, FDA, EU, and ICH guidelines.
- Documentation & Reporting: Write complex analytical protocols, validation reports, and Certificates of Analysis (CoA). Maintain precise and legible raw data.
- Client Interaction: Act as the primary technical point of contact for clients regarding method development, data interpretation, and laboratory investigations.
Required Qualifications - Education: Bachelor's degree in Chemistry or a closely related scientific discipline.
- Experience: 5+ years of experience in an analytical chemistry laboratory (CDMO or pharmaceutical QC environment highly preferred).
- HPLC Expertise: Minimum of 5 years of hands-on experience with HPLC method development and troubleshooting is essential.
- Regulatory Knowledge: Strong familiarity with cGMPs (21 CFR Parts 210, 211, and 820), ISO, and ICH guidelines, alongside a deep understanding of USP/EP pharmacopeia.
- Testing Specialization: Direct experience with either Dissolution testing or Aerosol/Inhalation testing.
- Communication: Exceptional written and verbal communication skills, with the ability to present data clearly to internal teams and external clients.
Preferred Skills & Attributes - Experience supporting manufacturing teams in GMP manufacturing for clinical supplies.
- Specialized expertise in Inhalation/Aerosol testing and small molecule analysis (oral solid dosage).
- Proficiency in gas chromatography (GC) and Karl Fischer moisture testing.
- Ability to hit the ground running, learn proprietary processes efficiently, and adapt to a fast-paced pipeline.
Why Join Us? This is a high-visibility role where you will directly manage all testing for a specific drug substance for a key client. We offer a structured Monday-to-Friday schedule in our state-of-the-art Cranbury, NJ facility, providing the perfect environment to showcase your analytical leadership.
Benefits - Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances).
- Health Benefits / Dental / Vision (Medix offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s)).
- 401k (Eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1).
- Short Term Disability Insurance.
- Term Life Insurance Plan.
