Manufacturing Science and Technology Scientist

Job Title: Manufacturing Science and Technology Scientist
Company: Intellectt Inc.
Location: Boston, MA
Employment Type: W2 Contract
Pay Rate: $55-60/hour
Work Arrangement: Onsite

Role Overview:
Provide scientific and technical leadership for product and technology transfers, innovation, and process
optimization. Support pharmaceutical small molecule sterile products and manufacturing platforms that include
solids, soft chewable tablets, non-sterile liquids, and sterile injectables, working closely with Manufacturing,
Engineering, Quality, and Validation.

Key Responsibilities:

• Lead product and technology transfers, process development, and product maintenance activities.

• Establish and optimize commercial manufacturing processes, including compounding and filling, across the relevant dosage forms and aseptic manufacturing platforms.

• Develop technical protocols, reports, manufacturing documents, and quality risk assessments.

• Lead development and engineering studies and batches to evaluate processes and support product integration.

• Manage project work scope, schedules, and budgets to deliver technically sound transfer and development activities.

• Identify critical quality attributes and develop strategies for defining acceptable process parameter ranges.

• Support Validation and Quality in establishing testing and characterization requirements for individual process steps and overall manufacturing process validation.

• Assess technical viability, resource needs, timelines, financial requirements, investments, and communication needs for product transfers.

• Support manufacturing efficiency and operational improvements with Quality, Engineering, Validation,mManufacturing, Planning, and Supply Chain.

Required Skills and Qualifications:

• Experience in pharmaceutical MS&T, technology transfer, process development, or process optimization.

• Strong knowledge of small molecule sterile products and aseptic manufacturing processes.

• Relevant experience with compounding, filling, and the dosage forms supported by the site.

• Ability to author technical protocols, reports, manufacturing documents, and quality risk assessments.

• Understanding of critical quality attributes, process parameters, process characterization, and manufacturing process validation.

• Experience leading technical studies and managing cross-functional projects, schedules, and resources.

• Strong scientific problem-solving, communication, and cross-functional collaboration skills.

Key Skills: Pharmaceutical MS&T, Technology Transfer, Process Development, Process Optimization, Small Molecule Sterile Products, Aseptic Manufacturing, Compounding, Filling, Sterile Injectables, Process Characterization, Critical Quality Attributes (CQAs)

Recruiter Contact:

Rudra Prasad Kunnath
Email:

prasad.kunnath@intellectt.com

Benefits: Employees hired into this position are eligible for benefits subject to applicable plan terms and eligibility requirements.

• Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for the full cost of insurance premiums.
• Retirement: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
• Paid Time Off: No PTO is provided beyond what is required by applicable state and local laws.

Equal Employment Opportunity: