Technical Product / Tech Transfer Lead

Technical Product/Tech Transfer Lead (6mo. Contract-to-Hire)

Join a premier global Contract Development and Manufacturing Organization (CDMO) that is rapidly expanding its state-of-the-art sterile manufacturing footprint in Baltimore. This organization is a strategic partner to leading pharmaceutical and biotech companies, specializing in the end-to-end development and commercialization of complex injectable products. With a reputation for scientific excellence and a commitment to Quality by Design, they offer a dynamic, client-facing environment where technical experts lead the transition of life-saving therapies from the lab to commercial scale.

The role is responsible for providing technical leadership across process development, technology transfer, and manufacturing support within the Manufacturing Sciences & Technology (MS&T) organization. This role serves as the primary technical subject matter expert (SME) for client products and processes, overseeing development, scale-up, process validation, transfer to manufacturing, and lifecycle management.

The position combines scientific expertise with client-facing involvement, ensuring robust process design, successful commercialization, and continuous improvement of pharmaceutical products. The role also acts as the primary point of contact for technical matters with clients and internal personnel.

Key Responsibilities:

• Lead process development activities including formulation, process optimization, scale-up, technology transfer, and troubleshooting.
• Design and oversee studies to evaluate process robustness and establish validation strategies.
• Serve as SME for manufacturing processes, equipment, and product lifecycle management.
• Analyze process data to identify critical process parameters (CPPs) and ensure consistent product performance.
• Apply Quality by Design (QbD), risk assessment, and statistical tools to support process characterization.

• Lead and coordinate technology transfer from development to commercial manufacturing.
• Provide ongoing technical support for commercial operations including deviations, investigations, and continuous process verification.
• Own technical documentation, including protocols, reports, risk assessments, and SOPs.

• Act as the primary technical point of contact (PoC) for client programs and internal stakeholders.
• Lead technical discussions with clients, providing strategic guidance and resolving complex problems.
• Collaborate cross-functionally with manufacturing, QA, QC, and engineering, validation, and project management teams.

• Drive process improvements, troubleshooting, and root cause investigations.
• Lead lifecycle management activities, including process monitoring and optimization.
• Support media fill programs, validation strategies, and regulatory submissions as needed
• Maintain and improve laboratory and manufacturing capabilities, including equipment oversight.

• Manage multiple cross-functional projects and ensure timely delivery of milestones.
• Provide technical guidance and mentorship to junior staff.
• Influence stakeholders and drive alignment across teams and organizations.
• Foster a culture of collaboration, innovation, and accountability.

Education & Experience

• Bachelor's degree with 8+ years, Master's degree with 57 years, or PhD with ~5 years of relevant experience.
• Degree in Chemical Engineering, Pharmaceutical Sciences, or related field.
• Experience in process development, tech transfer, and commercial manufacturing support.

Required Skills & Competencies

• Strong expertise in pharmaceutical process development, formulation, and manufacturing technologies
• Knowledge of sterile processing, lyophilization, and analytical characterization techniques.
• Experience with QbD, Risk Assessment tools, and statistical analysis methods.
• Strong understanding of cGMP, regulatory requirements, and validation principles.
• Excellent leadership, communication, and stakeholder management skills.
• Ability to manage complex projects in a fast-paced environment.

Physical & Work Environment

• Office, laboratory, and manufacturing environment with cross-functional interaction.
• Ability to analyze data, communicate technical information, and manage multiple priorities.
• Occasional travel may be required (Rare).