Senior Scientist, Sterile Drug Product Commercialization - Hybrid (Ireland)
Job Description
Our Sterile Drug Product Commercialization group within the Manufacturing Division is seeking an experienced and innovative Senior Scientist to join our team. We drive the scientific and engineering advancements necessary for the innovative and accelerated commercialization of novel Vaccines, Biologics, and Pharmaceutical products, including combination products.
This role will provide you with responsibility for key activities that support operational excellence, continuous improvement, and innovation. You will l be part of the Process Engineering group driving excellence in process scale-up, transfer, and validation.
Responsibilities:
Serve on cross-functional drug product (DP) working groups and support DP activities through filing and Process Performance Qualification (PPQ).
Ensure commercialization programs meet requirements related to science, quality, reliability, schedule, and cost.
Provide mentorship and technical oversight to employees, guiding them in addressing non-routine and difficult issues.
Design and execute DP development and commercialization studies, new product introduction, and process validation at commercial sites.
Develop and employ fit-for-purpose scale-down models and validate platform engineering and scientific models for sterile product and process commercialization.
Drive best practices for commercial site tech transfer, facility fit, and development of the DP control strategy.
Optimize processes towards standardized platforms for liquid, lyophilized, and combination product presentations.
Establish a culture of high performance, innovation, learning, empowerment, diversity, and inclusion.
Minimum Education Requirements:
B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 5 years of relevant experience, or a Master's degree in the same fields with 3 years of relevant experience, or a Ph.D. in the same fields.
Required Experience and Skills:
Technical expertise in drug-related manufacturing processes for large molecules, including laboratory and/or fundamental models for key unit operations.
Experience with technology transfer and scale-up of processes.
Excellent oral and written communication skills.
Ability to effectively articulate understanding of process science in a multi-disciplinary team environment.
Preferred Experience and Skills:
Experience in biologics drug product process operations, scale-up, and technology transfer of sterile products.
Knowledge of combination product development.
Working knowledge of regulatory requirements or current Good Manufacturing Practices ( cGMPs ) for commercialization of sterile drug products.
Working knowledge of statistical methods for DOE design and data analysis, SPC, MVA, and/or PAT techniques for manufacturing processes.
Experience in Data Analytics, Computer Modeling, and Digital Applications.
Working comprehension of analytical methods to characterize vaccines, biologics, and other sterile drug products.
Current Employees apply HERE
Current Contingent Workers apply HERE
Secondary Language(s) Job Description:
As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.
Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, please apply today.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
06/6/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date:06/06/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R294778