Sr. Scientist, Preclinical Development Biologics Product Development

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

• 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 4 years of experience 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)

eligibleforERP

PRD

To learn more about the PRD team click:Join Our Process Research & Development Team.

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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 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 have been designated as remote.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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 can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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