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Ms&T Pharmaceutical Jobs (NOW HIRING)

Novartis

Aseptic Drug Product MS&T Lead

Durham, NC · On-site

$138K - $257K/yr

As the Aseptic Drug Product MS&T Lead, you will play a critical leadership role at our Durham site ... Strong expertise in aseptic filling operations and pharmaceutical manufacturing processes.

Phlow Corp.

Sr. Director, Tech Transfer

Richmond, VA · On-site

$190K - $230K/yr

Minimum of 10 years of experience in the pharmaceutical industry, with expertise in tech transfer, MS&T, or manufacturing operations. * In-depth knowledge of chemistry and its application in ...

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What are some common challenges faced by MS&T professionals in the pharmaceutical industry?

MS&T professionals in pharmaceuticals often encounter challenges such as troubleshooting scale-up issues when transferring processes from development to full-scale manufacturing, ensuring regulatory compliance during process changes, and managing cross-functional collaboration between R&D, production, and quality teams. Additionally, adapting to new technologies and continuous improvement initiatives requires strong problem-solving skills and the ability to quickly learn evolving industry standards. These challenges make the role both dynamic and rewarding for those interested in technical problem-solving and process optimization.

What are the key skills and qualifications needed to thrive as an MS&T professional in the pharmaceutical industry?

To thrive as an MS&T Pharmaceutical professional, you need a solid background in pharmaceutical sciences, chemical engineering, or a related field, often supported by a relevant degree or advanced certification. Familiarity with process analytical technology (PAT), quality management systems (QMS), and regulatory compliance tools like GMP guidelines is essential. Strong problem-solving abilities, teamwork, and effective communication are crucial soft skills for collaborating across departments and troubleshooting manufacturing challenges. These skills ensure robust process optimization, regulatory adherence, and the consistent production of high-quality pharmaceutical products.

What is the difference between Ms&T Pharmaceutical vs Pharmaceutical Sales Representative?

AspectMs&T PharmaceuticalPharmaceutical Sales Representative
Required CredentialsDegree in pharmacy, life sciences, or related field; certification may be preferredDegree in life sciences, marketing, or related field; often requires pharmaceutical industry knowledge
Work EnvironmentLaboratory, manufacturing facilities, or office settingsField-based, visiting healthcare providers and pharmacies
Employer & Industry UsagePharmaceutical companies, biotech firms, research institutionsPharmaceutical companies, medical device firms, healthcare industry

Ms&T Pharmaceutical roles typically involve research, development, or technical support within pharmaceutical companies, requiring scientific credentials. In contrast, Pharmaceutical Sales Representatives focus on promoting products to healthcare providers, often working in the field. Both roles are integral to the pharmaceutical industry but differ in daily tasks, environment, and skill sets.

What is MS&T in the pharmaceutical industry?

MS&T stands for Manufacturing Science and Technology in the pharmaceutical industry. It is a specialized function that focuses on improving, optimizing, and supporting manufacturing processes. MS&T professionals work to ensure that products are produced consistently, safely, and efficiently, often acting as a bridge between research and development (R&D) and full-scale manufacturing. They are involved in technology transfer, process validation, troubleshooting, and continuous improvement initiatives. This role is critical for maintaining product quality and meeting regulatory requirements.
What job categories do people searching Ms&T Pharmaceutical jobs look for? The top searched job categories for Ms&T Pharmaceutical jobs are:
Ms T Pharmaceutical jobs near you
Infographic showing various Ms&T Pharmaceutical job openings in the United States as of August 2026, with employment types broken down into 83% Full Time, 10% Part Time, and 7% Contract. Highlights an 90% Physical, 3% Hybrid, and 7% Remote job distribution.

Product Process Validation Manager

kindeva

Bridgeton, MO • On-site

Full-time

Re-posted 10 days ago

Kindeva rating

6.7

Company rating: 6.7 out of 10

Based on 9 frontline employees who took The Breakroom Quiz

Job description

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

The is an exciting opportunity as Product Process Validation Manager is a key member of the Manufacturing Science & Technology (MS&T) organization, responsible for leading process validation strategy and execution across the product lifecycle. This role oversees the design, authorship, and facilitation of technology transfer activities, Process Performance Qualification (PPQ) protocols and reports, and supporting ongoing Continued Process Verification (CPV). The manager partners closely with Process Development, Quality, Manufacturing, and Regulatory Affairs to ensure robust, compliant, and efficient validation programs. This position reports directly to the Director of MS&T.

Role Responsibilities

Process Validation & PPQ

  • Lead the development, authorship, and execution of process validation strategies in alignment with regulatory expectations (e.g., FDA, EMA, ICH Q8–Q11).
  • Write, review, and approve PPQ protocols, sampling plans, risk assessments, and final reports.
  • Facilitate cross-functional PPQ readiness, including coordinating activities with Manufacturing, Quality Control, and Quality Assurance.
  • Ensure validation deliverables meet internal standards and external regulatory requirements.

Technology Transfer

  • Serve as the MS&T lead for technology transfer of new products, processes, or scale-up activities into manufacturing.
  • Develop and maintain tech transfer plans, process descriptions, and knowledge transfer documentation.
  • Drive process fit-gap assessments, risk analyses, and mitigation strategies.
  • Support equipment and facility readiness, including URS development and process capability assessments.

Continued Process Verification (CPV)

  • Partner with data analytics and quality teams to monitor process performance, identify trends, and drive data-based decision-making.
  • Lead investigations and corrective actions related to process performance deviations or CPV signals.

Cross-Functional Leadership

  • Collaborate with Process Development to translate laboratory-scale processes into robust, scalable manufacturing processes.
  • Support Regulatory Affairs with process validation content for submissions, responses to regulatory queries, and inspections.
  • Provide technical leadership during audits and regulatory inspections.
  • Mentor and guide junior MS&T staff in validation and tech transfer best practices.

Documentation & Compliance

  • Ensure all validation and tech transfer documentation is accurate, complete, and audit-ready.
  • Maintain strong alignment with internal quality systems, change control, and document management processes.
  • Champion continuous improvement initiatives to enhance validation efficiency and process robustness.

Basic Qualifications

  • Bachelor’s or Master’s degree in Engineering, Life Sciences, Biotechnology, or related field.
  • 7+ years of experience in biopharmaceutical or pharmaceutical manufacturing, MS&T, process validation, or related technical functions.
  • Demonstrated expertise in PPQ, CPV, and technology transfer.
  • Strong understanding of cGMP regulations and global validation guidelines.
  • Excellent technical writing, communication, and project management skills.

Preferred

  • Experience with biologics, cell therapy, gene therapy, or aseptic manufacturing.
  • Familiarity with statistical tools (e.g., JMP, Minitab) for process analysis.
  • Prior leadership or team management experience.
  • Experience supporting regulatory inspections.

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