Sr. Scientist, Preclinical Development - Biologics Product Development jobs in United States
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Merck · 19 hours ago

Sr. Scientist, Preclinical Development - Biologics Product Development

Merck is a leading global healthcare company, and they are seeking a Sr. Scientist in Preclinical Development for Biologics Product Development. The role involves designing and developing sterile products for biologics and requires collaboration with key stakeholders to drive project milestones.

BiotechnologyHealth CareMedicalPharmaceutical
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Comp. & Benefits
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H1B Sponsorednote

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

Qualification

Biologic molecule designFormulation screeningProcess developmentProtein StabilityCharacterizationStability predictive modelingProtein-Protein InteractionInterpersonal RelationshipsAccountabilityInnovationAdaptabilityCross-Functional Teamwork

Required

Master's 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/or knowledge in one or more of the following: Protein Stability
Experience and/or knowledge in one or more of the following: Protein-Protein/Protein-Excipient Interaction
Experience and/or knowledge in one or more of the following: Biologic molecule design
Experience and/or knowledge in one or more of the following: Formulation screening
Experience and/or knowledge in one or more of the following: Characterization
Experience and/or knowledge in one or more of the following: Process development or process modeling
Experience and/or knowledge in one or more of the following: Stability predictive modeling
Experience and/or knowledge in one or more of the following: 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 approaches, definition 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)

Benefits

Medical
Dental
Vision healthcare
Other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days

Company

Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.

Funding

Current Stage
Public Company
Total Funding
$5.59M
Key Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO

Leadership Team

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Betty Larson
Executive Vice President and Chief Human Resources Officer
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Dean Li
Executive Vice President and President, Merck Research Laboratories
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Company data provided by crunchbase