Process and Analytical Technology Transfer Lead

Galderma•Boston, MA

60d•$90,000 - $130,000

About The Position

The Process and Analytical Technology Transfer Lead will lead and support the transfer of drug substance, drug product, and/or medical device processes and QC analytical methods into commercial manufacturing facilities. Customers may be internal or external partners, and the transfer may exist from clinical production through process performance qualification and commercial operations.

Requirements

Bachelor’s or Master’s degree or PhD in a relevant scientific or engineering field, such as Chemistry, Biochemistry, Biological Sciences, Chemical Engineering, or a related discipline with approx. 6-10 years of experience in a pharmaceutical, biopharmaceutical, medical device or manufacturing environment.
Experience including method validation, process validation, transfer, commercialization and manufacturing support and troubleshooting
Knowledge of regulatory standards and GMP guidelines
Strong project management skills, with the ability to manage multiple projects simultaneously.
Excellent problem-solving skills and attention to detail.
Strong leadership, organizational, and communication skills.
Ability to work effectively in a cross-functional team environment.
All applicants must be legally authorized to work in the United States without requiring any type of work sponsorship. This position does not offer visa sponsorship now or in the future. If you require sponsorship, please do not apply. Individuals requiring sponsorship are not eligible and should not apply.

Nice To Haves

Process experience in drug substances, drug products and/or familiarity with biotech unit operations.
Analytical Laboratory experience preferably in a biotechnology, pharmaceutical, contract research organization (CRO) or contract laboratory organization (CLO).
Experience with customer relationship management
Experience in a GMP environment
Experience in drug substance and/or drug product manufacturing.
Experience with quality systems and risk management tools (e.g. deviation, change control, CAPA, LIMs, FMEA)
Experienced in Lean or Six Sigma methodologies

Responsibilities

Site representation in global technology transfer process.
Subject matter expert (SME) for Technology Transfer and Analytical Method Validation
Implement programs for smooth transition of analytical methods into full production readiness, representing MS&T in Tech Transfer projects.
Collaborate with the team to ensure that method transfer optimizes the process in terms of efficiency, cycle time, reliability, and serviceability.
Process Technical Transfer : Lead and support cross-functional tech transfer for upstream and downstream processes.
Generate and review tech transfer documentation, such as tech transfer plan, gap/risk assessments and validation plans/protocols.
Serve as subject matter expert on process and provide technical oversight at receiving manufacturing site.
Analytical Method Transfer Management: Lead and coordinate the end-to-end process of transferring analytical methods from either internal production or across external sites.
Develop and support analytical method tech transfer and execution, including method verification, transfer and validation.
Identify analytical needs and perform risk and gap assessments.
Collaborate cross functionally with product sciences, quality control, and quality teams to ensure the robustness of new technologies.
Ensures all deliverables are in place prior to each project milestone.
Project Management: Create detailed project plans and timelines for tech transfer activities and communicate progress to stakeholders.
Track project deliverables, identify and address roadblocks, and ensure all actions are completed on time.
Documentation & Compliance : Serve as SME to review, author and deliver SOPs, transfer plans, protocols, reports and transfer summary reports.
Ensure compendial method oversight and scientific guidelines (e.g. ICH, EMA, FDA).
Support regulatory requests and inspections.
Cross-Functional Collaboration: Coordinating subject matter experts within Product Sciences, Quality Control, MS&T, Quality and Regulatory Affairs and other site related functions or experts, to ensure that requirements are met.
Support best practices for tech transfer and method validation as required.
Troubleshooting & Problem Solving: Identify potential risks in the method transfer process and develop mitigation strategies.
Support the QC team to investigate any project challenges with appropriate risk assessment tools.
Training & Support: Ensure that receiving sites are adequately trained on new methods or technologies.
Provide technical expertise and leadership to teams throughout the transfer phases.
Continuous Improvement: Lead efforts to continuously improve technology transfer processes, ensuring the implementation of best practices.
Evaluate and implement process improvements to reduce transfer time and enhance product quality.

Benefits

In addition to base salary, we provide an opportunity to participate in an annual short-term incentive program that is based on corporate performance with a multiplier focused on individual performance.
We offer a competitive and comprehensive benefits program including health insurance, 401(k) plan with employer match, a generous paid time off policy, hybrid work schedules and more.
You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
You will also have access to a range of company benefits, including a competitive wage with shift differential, annual bonus opportunities and career advancement and cross-training.

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