Senior Scientist, Process Engineering
Upper Providence, Pennsylvania
ResponsibilitiesLocation Upper Providence, PennsylvaniaUS Job ID JR-031802
- Conduct laboratory experimentation and analytical testing of putative formulations & drug product manufacturing
- Follow administration/delivery approaches for select protein therapeutic assets, including contributing to, the conception & evaluation of conventional & novel product matrices and administration modalities
- Partner closely with the manufacturing groups during process development and technology transfers
- Actively participate with combination drug product assessment and collaborate with device engineering
- Physicochemical and bioanalytical characterization of native and modified biopharma compounds
- Collaborate with the Bioanalytical Sciences group to develop & transfer stability-indicating analytical methods for use in product development
- Oversee release & stability testing; crafting & execution of non-GMP stability protocols to test quality & stability of product formulations
- Engage with the Analytical Technology Transfer and Stability group to craft GMP stability protocols
- Assess resultant data; working closely with internal & external discovery and development support partners as needed
- Maintain accurate, complete laboratory records and ease use of electronic data & information gathering, capture, archiving and communications techniques.
- Assist in preparation and review of manufacturing batch records, SOPs, and regulatory documentation as appropriate.
The selected candidate must possess knowledge and/or competencies related to:
- Protein and peptide chemistry
- Formulation and drug delivery/device development
- Drug product manufacturing
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time
Job Requirements and Qualifications:
Basic Qualification: (Required Education & Experience)
- Master’s degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline
- 3-5 years of similar experience in protein formulation and drug delivery development experience
- Bachelor’s degree Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline
- 5-7 years of similar experience in protein formulation and drug delivery development experience
Preferred Experience: (candidates who meet BQs & these qualifications (PQs) especially qualify to be shortlisted for candidate submission)
- 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 (e.g., solution (vial/PFS), or lyophilization; container/closure assessment & selection), drug delivery (e.g., combination product, device & 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 (eg MFI, FlowCam, Archimedes), capillary electrophoresis & 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 & 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 remains in a stationary position more than 25% of the time
- The person in this position needs to occasionally move inside and outside labs
- 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.
- Regularly move or lift up to 25 pounds and occasionally move or lift up to 100 pounds
- Specific vision abilities required by this position include without limitation, the ability to observe details at close range (within a few feet of the instrument), 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
- Must be able to work in a laboratory, controlled environments requiring personal protective equipment.
- Job pace may be fast and job completion demands may be high.
- Employee may be required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include: Identifying, handling, generating, accumulating, storing, labeling.
- Ensure safety, security, and the environment in all aspect of the daily activities, and any potential safety hazards are addressed and corrected immediately.
- Understand ergonomic relationship between people, equipment and working environment.
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
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