USA - Scientist

The Fountain Group is currently seeking a Senior Scientist for a prominent client of ours. This position is located at Lexington, MA. Details for the position are as follows:

Title: Senior Scientist - Drug Product Development
Pay Rate: $75.00 - $82.00/hr 
Position Type: 1 Year (With Possible Extension/Hire)
Location: Lexington, MA

Job ID: SHPGJP00010178

Shift Hours: Standard Shift (4 days onsite, 1 day remote)

Responsibilities:
We are seeking a highly motivated Scientist with experience in parenteral (injectable) sterile drug product development to support formulation development, manufacturing, and characterization activities in a GMP environment. The ideal candidate will have hands-on experience with sterile injectable products, compatibility and stability studies, and in-use assessments while collaborating with cross-functional teams to support product development.

Key Responsibilities:

• Support the development and manufacturing of parenteral/sterile injectable drug products, including formulation development and process optimization.
• Perform compatibility, stability, and in-use studies for injectable and infusion products, including dose preparation, dilution, hold-time, filter compatibility, infusion-set compatibility, and simulated clinical administration assessments.
• Execute laboratory activities in a GMP environment, including compounding, sterile filtration, filling, and lyophilization.
• Conduct physicochemical and analytical testing using techniques such as micro-flow imaging (MFI), pH, osmolality, protein concentration, and size-exclusion chromatography (SEC).
• Author and review technical documents, including study protocols, reports, batch records, and GMP documentation, while maintaining accurate laboratory records.
• Utilize electronic document management systems such as Veeva, Documentum, or equivalent EDMS.
• Ensure compliance with GMP, GDP, ICH guidelines, SOPs, and applicable regulatory requirements.
• Collaborate with cross-functional teams to support formulation, manufacturing, analytical, and quality activities throughout drug product development.

Qualifications:

• Bachelor's degree with 6+ years, Master's degree with 4+ years, or PhD with 0–2 years of relevant pharmaceutical industry experience.
• Strong experience in parenteral (injectable) sterile drug product development, formulation, and manufacturing.
• Experience performing compatibility, stability, and in-use studies for injectable or infusion products.
• Hands-on experience with compounding, filtration, filling, and lyophilization in a GMP environment.
• Experience with analytical methods including MFI, pH, osmolality, protein concentration, and SEC is preferred.
• Strong technical writing skills with experience preparing protocols, reports, batch records, and GMP documentation.
• Experience working with Veeva, Documentum, or similar electronic document management systems is preferred.

Excellent communication, organization, and collaboration skills with the ability to work effectively in a cross-functional team.

Required Skills:

• Parenteral (Injectable) Sterile Drug Product Development & Formulation
• GMP Manufacturing Experience (Compounding, Filtration, Filling & Lyophilization)
• Compatibility, Stability & In-Use Studies for Injectable/Infusion Products
• Analytical Testing (MFI, pH, Osmolality, Protein Concentration, SEC)
• GMP Documentation & Technical Writing (Protocols, Reports, Batch Records, EDMS)

By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy.