Overview
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 the skin, we shape our lives and 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 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
Responsibilities
* Lead and support the transfer of drug substance, drug product, and/or medical device processes and QC analytical methods into commercial manufacturing facilities. Transfers may be internal or external and may exist from clinical production through process performance qualification and commercial operations.
* Serve as site representation in global technology transfer processes.
* Act as 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 cross-functional teams to optimize method transfer for efficiency, cycle time, reliability, and serviceability.
* Lead and support cross-functional tech transfer for upstream and downstream processes; generate and review tech transfer documentation (tech transfer plans, gap/risk assessments, validation plans/protocols); provide technical oversight at receiving manufacturing sites.
* Lead and coordinate end-to-end analytical method transfer from internal or external sites; develop and support method transfer/validation, perform risk and gap assessments, and ensure robustness with Product Sciences, Quality Control, and Quality teams.
* Create detailed project plans and timelines; track deliverables and milestones; communicate progress to stakeholders and manage roadblocks.
* Review, author and deliver SOPs, transfer plans, protocols, reports and transfer summary reports; ensure compendial method oversight and adherence to ICH, EMA, and FDA guidelines; support regulatory requests and inspections.
* Coordinate cross-functional SMEs within Product Sciences, Quality Control, MS&T, Quality, Regulatory Affairs and other site functions to ensure requirements are met and best practices are followed.
* Identify potential risks in the method transfer process and develop mitigation strategies; support QC investigations with appropriate risk assessment tools.
* Ensure receiving sites are adequately trained on new methods or technologies and provide technical leadership throughout transfer phases.
* Lead continuous improvement efforts to reduce transfer time and enhance product quality by implementing best practices and process improvements.
Qualifications
* Bachelor’s, Master’s, or PhD in a relevant scientific or engineering field (e.g., Chemistry, Biochemistry, Biological Sciences, Chemical Engineering) with approximately 6–10 years of experience in pharmaceutical, biopharmaceutical, medical device, or manufacturing environments.
* Experience in 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 concurrently.
* Excellent problem-solving skills and attention to detail.
* Strong leadership, organizational, and communication skills; ability to work effectively in a cross-functional team.
Preferred Qualifications
* Process experience in drug substances, drug products and/or familiarity with biotech unit operations.
* Analytical laboratory experience in biotechnology, pharmaceutical, CRO, or CLO environments.
* Experience with customer relationship management and in a GMP environment.
* Experience with quality systems and risk management tools (e.g., deviation, change control, CAPA, LIMS, FMEA).
* Experience with Lean or Six Sigma methodologies.
What We Offer In Return
You will be working for an organization that embraces diversity and inclusion and believes better outcomes come from reflecting diverse perspectives. Benefits include competitive wages with shift differentials, annual bonus opportunities, and opportunities for career advancement and cross-training.
Next Steps
* If your profile is a match, you will be invited 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 who are different. We value what every team member brings. Professionalism, collaboration, and a friendly, supportive ethos create an environment where people thrive and excel.
Employers’ Rights
This job description does not list all duties of the job. You may be asked to perform other duties. You will be evaluated on your performance of the tasks listed. The employer has the right to revise this job description at any time. This description is not an employment contract, and either party may terminate employment at any time, for any reason. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Management and Manufacturing
Industries
* Pharmaceutical Manufacturing
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