Senior Scientist, Preclinical Development (Onsite)

Job Description

Sterile Product Development (SPD) group is responsible for developing non-oral dosage forms (injections implants inhaled ocular) for biologics mixed modalities vaccines and small molecules from preclinical toxicology studies to commercialization. Our development teams ensure robust composition primary packaging/ device and process selection through deep fundamental understanding and characterization such that the process is scalable without compromising stability safety efficacy and delivery. During development we leverage smart experimental design cutting edge analytical tools and predictive approaches to inform molecule formulation and process summary our team enables the translation of preclinical candidates into non-oral drug products.

Primary Responsibilities

This is a lab based (on-site) role responsible for designing and developing sterile products for biologics (monoclonal antibodies fusion proteins antibody-drug conjugates) drugs for injectable and ophthalmic routes of administration. Support product development of both early and late stage assets while developing mechanistic understanding of the degradation and process design space. Key studies include screening and developing robust drug product composition developing scalable process and defining primary packaging. Coordinate good practice (GXP) manufacture activities and appropriate compatibility characterization to enable processing of drug product and dosage administration in toxicology and clinical study. Build deep fundamental knowledge around the drug product and document experimental findings and conclusions in formulation development reports and regulatory filings. Active participation and leadership on formulation development teams and interfacing and collaborating with key stakeholders to drive project milestones

Take initiative motivated to excel have a strong technical background have excellent communication and interpersonal skills

Education Requirements

Masters with four years or Ph.D. Degree in Chemical/ Biochemical/ Biomedical Engineering Pharmaceutics Pharmaceutical Chemistry Pharmaceutical Sciences Chemistry Biochemistry or related field

Experience and Skills

Experience and/or knowledge in one or more of the following:

Protein Stability

Protein-Protein/Protein-Excipient Interaction

Biologic molecule design

Formulation screening

Characterization

Process development or process modeling

Stability predictive modeling

Basic understanding of sterile product development

Preferred

Course work in biochemistry protein design pharmaceutics physiology pharmacokinetics protein sciences chemical kinetics Transport phenomenon physical pharmacy is highly desirable.

Biologics formulation design/process development alternative processing approachesdefinition of critical attributes for process scale-up analytical development and Chemistry Manufacturing and Control filing for sterile dosage forms including ocular dosage forms peptide therapeutics and non-conventional drug delivery technologies (e.g. emulsions suspensions injectable depot)

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The salary range for the primary location of this role is:

This range reflects the Companys reasonable expectation of the base salary applicable to this role at the time of posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to our Talent Acquisition team will provide further information to you relevant to your location.

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