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 bodys 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 :

Preferred Qualifications :

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.

About the Compensation :

The base salary range for this role is determined based on several factors. These include but are not limited to job accountabilities; skill sets; experience and training; certifications; work location; competitive market rates and other business needs. At Galderma it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on a unique combination of factors for each role. A reasonable estimate of the base salary hiring range for this role is $90000 - $130000 USD.

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.

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

Our people make a difference

At Galderma youll 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 addition reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.

Key Skills

Airside Operations,Accountancy,Data Warehousing,Actuary,Import & Export,Corrosion

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 90000 - 130000