SHW- Senior MS&T (Manufacturing, Science & Technology) Scientist

Job Summary:

TriRx Pharmaceutical Services is a contract development and manufacturing organization (CDMO) committed to creating a better outsourcing experience for customers in the human health pharmaceutical industries.

The Manufacturing, Science & Technology (MS&T) group is hiring a Senior MS&T Scientist to provide subject matter expertise for leading and managing activities including product/technology transfers, innovation, and process optimization for pharmaceutical products for Oral Solid Dose, Soft Chewable Tablets, Non- sterile liquids or Injectable technology platforms.

In addition to the technical expertise, this position will lead teams that support these transfers. As a technical project lead, the position will provide general oversight of technical communications, evaluations, timelines and requirements with internal teams and external clients.

Responsibilities

• Lead product/technology transfers, process development, product maintenance activities establishing and optimizing commercial manufacturing processes for compounding and filling of solids, soft chewable tablets, non-sterile liquids and sterile injectable (aseptic manufacturing) platforms working closely with Manufacturing, Engineering, and Quality organizations. ·
• Generate technical protocols, reports, manufacturing documents and author Quality risk assessments to detect quality and technological risks. Lead development/engineering studies and batches. ·
• Manages and controls the development of each project’s work scope and schedules required for the support of key product integrations, ensuring they are completed on budget, on schedule, and technically correct.
• Identify critical quality attributes and the strategy for defining acceptable ranges for process parameters. Understands the product and process complexity and supports Validation and Quality in establishing the testing/characterization requirements for various process steps and overall manufacturing process validation. ·
• Serve as single point of contact for internal teams and external customers as transfer lead for all technology and product transfers. Provide proper levels of customer service and act as key interface with customers as needed. ·
• Lead assessments regarding timelines, technical viability, resources, financial, investments, and communications needed to support product transfer activities. ·
• Support MFG efficiency and operations projects by interfacing with all internal departments (Quality, Engineering, Validation, Manufacturing, Planning, Supply Chain).
• Ability to analyze and troubleshoot problems to effectively direct the activities of a cross-functional project team.

Qualifications

• Bachelor’s degree in industrial pharmacy, Pharmaceutics, Chemical Engineering or related scientific field
• At least 6 years of industry experience in technology/product transfers and process optimization in a GMP environment or 4 years of industry experience with masters is preferred.
• Familiarity with processing equipment and technologies utilized in GMP manufacturing facilities for solid dose, soft chewable tablets, non-sterile liquids and injectable platforms (at least in 2 areas) and sufficient experience in a commercial GMP environment.
• Experience in product/technology transfer activities and ability to author technical documents in support of all activities.
• Experience in leading technical cross-functional teams or relevant technical project management experience is highly desirable.
• Strong communication skills and computer literacy are mandatory.
• Experience with operational excellence, statistical analysis and ongoing process verification is desirable.
• Must be able to effectively interact with senior executives, senior technical managers, and external customers.
• Demonstrate high levels of value and integrity while instilling the company vision, values and beliefs in others by example

EEO Statement

TriRx Pharmaceutical Services is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.