Sr. Scientist, Drug​/Device Combo Pdts

Job Description

Join our company’s Device Product & Process Development (DPPD) Team, which focuses on the design, development, and commercialization of novel biologic/drug/vaccine-device combination products for safe and effective delivery to their intended sites of action. The DPPD Team oversees the development of the device constituent within our pipeline of combination products, spanning various therapeutic areas and routes of administration, including inhalation, implantation, and injection.

The Senior Scientist will lead DPPD within our Company Research Labs is seeking a talented, self‑motivated, and highly collaborative Scientist with knowledge of container closure integrity (CCI) technology and experience with test method development, method validation, and testing for various product images (vials, syringes, cartridges, and injectors) and secondary packaging.

The candidate will develop methods for our company’s device and combination product pipeline, inclusive of small molecule, biologics, and vaccine products.

• Function as an analytical subject matter expert (SME), troubleshooting and optimizing analytical methods, with a focus on container closure integrity methods
• Ability to build, mentor, and train laboratory staff and users, ensuring proper execution of test methods, adherence to procedures, and consistent data quality
• Develop, validate, and execute feasibility CCI studies for complex combination devices & delivery systems
• Author technical reports and testing protocols
• Collaborate with cross‑functional teams to ensure successful tech transfer of analytical methods between QC labs
• Excellent communication, prioritization, presentation, negotiation, project management, and organizational skills
• Self‑motivated with ability to work independently
• Skilled in laboratory good documentation practices and electronic documentation systems
• Working knowledge of analytical test method technology transfer process
• Willing to travel

• B.S./M.S in Mechanical Engineering, Biomedical Engineering, Industrial & Systems Engineering, Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field/discipline with a minimum of 4 years of relevant work experience in the pharmaceutical, biotechnology, or medical device industries

• Relevant analytical execution, development, validation, and/or quality control (QC) for container closure integrity as it pertains to small molecule, biologics, and vaccine products
• Ability to learn new techniques, troubleshooting assays, author and review technical documents
• Excellent organizational skills to manage multiple projects

• cGMP experience
• Hands‑on experience in CCIT method development, validation, and troubleshooting for injectable therapeutics. Candidate should be familiar with the following CCIT technologies for this purpose: dye ingress, high voltage leak detection, vacuum and pressure decay, laser headspace analysis
• Fluency with industry‑related guidance USP and ISO‑13485
• Good technical, communication (oral and written), interpersonal, and teamwork skills
• Ability to effectively identify and communicate risks
• Experience with other analytical methodologies

Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a Hybrid work consisting of three total days on‑site per week, Monday – Thursday, although the specific days may vary by site or organization, with Friday designated as a remote‑working day, unless business critical tasks require an on‑site presence. This Hybrid work model does not apply to, and daily in‑person attendance is required for, field‑based positions;

facility‑based, manufacturing‑based, or research‑based positions where the work to be performed is located at a Company site; positions covered by a collective‑bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that…