Process and Analytical Technology Transfer Lead

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

Job Title: Process and Analytical Technology Transfer Lead

Location: Boston, MA

Job Description:

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.   

Key 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.
   

Skills and Qualifications:

• 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.

Preferred Qualifications:

• 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

What we offer in return

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.

Next Steps

• If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
• The next step is a virtual conversation with the hiring manager
• The final step is a panel conversation with the extended team

Our people make a difference

At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.
 

Employers’ Rights:

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not an employment contract, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.