Senior Formulation Scientist
2 weeks ago
We are seeking a highly skilled and experienced Senior Formulation Scientist to join our team at PerkinElmer. As a key member of our Process Development group, you will be responsible for developing and implementing innovative formulation strategies for our pharmaceutical products.
Key Responsibilities- Conduct laboratory experimentation and analytical testing of putative formulations and drug product manufacturing processes.
- Develop and evaluate conventional and alternative biopharmaceutical protein formulation and drug product development strategies.
- Partner closely with manufacturing groups during process development and technology transfers.
- Collaborate with the Bioanalytical Sciences group to develop and transfer stability-indicating analytical methods for use in product development.
- Oversee release and stability testing, and craft and execute non-GMP stability protocols to test quality and stability of product formulations.
- Engage with the Analytical Technology Transfer and Stability group to craft GMP stability protocols.
- Assess resultant data and work closely with internal and external discovery and development support partners as needed.
- Maintain accurate and complete laboratory records and ease use of electronic data and information gathering, capture, archiving, and communications techniques.
- Assist in preparation and review of manufacturing batch records, SOPs, and regulatory documentation as appropriate.
- PhD degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline.
- 1-3 years of protein formulation and drug delivery development experience.
- Experience with both conventional and alternative biopharmaceutical protein formulation and drug product development, including the application of DOE and other statistically based experimental design/interpretation approaches.
- Experience with protein product manufacturing processes and development, including solution (vial/PFS), or lyophilization; container/closure assessment and selection, drug delivery (e.g., combination product, device and administration kit) feasibility and compatibility evaluation.
- Experience and understanding of multiple bioanalytical and biophysical assessment techniques for product characterization and product stability evaluation, including HPLC, SDS-PAGE/CGE, SEC, Spectroscopy (UV/VIS, fluorescence, or CD), DSC, particles evaluation by HIAC and/or orthogonal techniques (e.g. MFI, FlowCam, Archimedes), capillary electrophoresis and chip-based methods, etc.
- Experience in authoring, contributing to, and critical review of successful regulatory submissions, with particular emphasis on late clinical phase submissions, BLA/MAA filings, response to regulatory questions, and pre-approval inspection experience.
- Experience in working with in vivo/in vitro models to critically assess formulation and delivery modalities.
- Experience in drug product manufacturing technology transfer to commercial and/or scale-up of clinical drug product manufacturing capabilities would be beneficial.
- Must be able to work in a laboratory, controlled environments requiring personal protective equipment (e.g., lab coat, safety glasses, etc.) in laboratory.
- Job pace may be fast and job completion demands may be high.
- Must be able to remain in a stationary position more than 25% of the time.
- The person needs to occasionally move between labs, corridors, adjoining rooms, and buildings onsite Frequently operate on instruments, objects, tools or controls, which will require regularly bending, squatting, stretching and reaching in order to perform in a service function.
- Occasionally move or lift up to 25 pounds (potential for occasional lifting of up to 50 pounds).
- Specific vision abilities required by this position include without limitation, the ability to observe details at close range distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus in order to perform the essential service functions of this position.
- Occasionally operates a computer and other office machinery, such as a calculator, copy machine, and computer printer.
- Employee may be required to handle hazardous waste according to local, state, and federal regulations. Duties may include identifying, handling, generating, accumulating, storing and labeling hazardous waste.
- Potential risk to lab-based hazards including but not limited to extreme temperature, biological materials, and hazardous chemicals.
- May be required to complete Medical Clearance, Respiratory Protection Training, and Fit Testing to wear a respirator as protection against hazards present in the laboratory environment.
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