Senior Scientist, R&D, Primary Drug Packaging
Radnor, PA - USA
Job Summary
This is an onsite position requiring the team member to be onsite 4 days a week
No relocation is avialable for this opportunity.
Who We Are:
At West were a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily Wests indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future
Theres no better place to join an inclusive community of professionals with opportunities for lifelong learning growth and development. Supported by benefit programs we empower the physical mental emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
The Senior Scientist Primary Drug Packaging will be responsible for leading technical activities related to the development evaluation selection and lifecycle management of primary packaging systems for pharmaceutical and drug products including biologics vaccines cell and gene therapies mRNA/LNP-based products high-value injectables and other complex drug products. This role provides scientific and technical expertise in container closure systems material selection compatibility performance testing and regulatory support to ensure packaging solutions meet product process quality and patient requirements.
The person will work cross-functionally with R&D Analytical Services Quality Regulatory Technical Customer Support Product Development and Commercial teams to generate scientifically sound data that supports product development customer programs technical investigations and lifecycle management. The role requires a strong foundation in laboratory science analytical testing data interpretation and good documentation practices.
This position is intended for an early-career professional who can independently execute defined technical workstreams contribute to experimental design analyze results and communicate findings with appropriate supervision.
- Lead the technical evaluation and selection of primary drug packaging components including stoppers seals syringes cartridges vials and related elastomeric or polymer-based systems.
- Design execute and interpret scientific studies related to packaging functionality compatibility integrity extractables/leachables considerations product-contact performance and stability.
- Provide subject matter expertise on container closure systems for injectable drug products including biologics and ATMPs.
- Execute and support studies evaluatingcontainer closure integrity sealing performance and system robustness for injectable packaging configurations.
- Identify gaps and initiate programs for novel containment and delivery solutions for emerging drug modalities from early-stage feasibility through commercialization and lifecycle management.
- Collaborate with internal and external stakeholders to define packaging requirements based on product characteristics processing conditions regulatory expectations and customer needs.
- Author and review technical reports protocols risk assessments study summaries and scientific publications.
- Evaluate material and component changes for technical impact product suitability and compliance risk.
- Drive continuous improvement in test methods technical standards scientific processes and packaging selection strategies.
- Mentor junior scientists and provide technical guidance across project teams.
- Participate in customer-facing technical discussions and represent the organization as a packaging science expert when needed.
- Maintain awareness of relevant pharmacopeial industry and regulatory expectations related to primary packaging and container closure systems.
- Ph.D. in Pharmaceutical Sciences Materials Science Chemistry Chemical Engineering Biomedical Engineering Packaging Science or related scientific discipline with4 yearsof relevant experience; OR
- Masters degree in a related field with7 years of relevant experience
- Minimum of 5 years of experience can include time spent either in industry or graduate school
- Demonstrated experience in pharmaceutical primary packaging parenteral packaging container closure systems or drug packaging development.
- Strong scientific knowledge of packaging materials especially elastomers polymers glass coatings and component-product interactions.
- Experience designing and interpreting laboratory studies and technical evaluations.
- Strong technical writing problem-solving and cross-functional collaboration skills.
- Hands on experience with drug product characterization and material compatibility studies.
- Knowledge of container closure integrity extractables and leachables particulate control sterilization compatibility and packaging functionality testing.
- Familiarity with relevant regulatory and industry standards such as USP EP FDA EMA ICH and ISO expectations related to primary packaging.
- Experience in customer-facing technical roles or external collaboration.
- Knowledge of quality systems change control risk management and deviation/investigation processes.
- Experience mentoring junior team members or leading technical workstreams. #LI-NJ1 #LI-ONsite
- Light work exerting negligible amount of force frequently to move objects.
- Job-related activities require a mental skill or ability such as quick decision making interpreting data reading writing and presentation of findings
West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race religion color national origin gender sex gender identity sexual orientation age marital status veteran status or disability status. If you have a special need that requires accommodation in orderto apply to West please send an email to . Where permitted by law an offer of employment with West Pharmaceutical Services or any of its subsidiary or affiliate companies is contingent upon the satisfactory completion of background screening.
Required Experience:
Senior IC
About Company
West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products.