Responsibilities

Job Responsibilities:

• 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.
• Maintain training and compliance in areas of health and safety, security, environmental and operational aspects of daily activities in the working environment.

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

Job Requirements and Qualifications:

Basic Qualification: (Required Education & Experience)

• PhD degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline
• 1-3 years of protein formulation and drug delivery development experience

OR

• Master’s degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline
• 5-7 years of similar experience in protein formulation and drug delivery development experience

OR

• Bachelor’s degree Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline
• 10 or more 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.

Working Environment:

• 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.

The annual compensation range for this full-time position is $87,360.00 to $131,040.00. The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.