Senior Scientist, Formulation Development
If you find science, speed, and success exhilarating, you have come to the right place.
Novavax, Inc (Nasdaq:
NVAX) is a biotechnology company that creates transformational vaccines that address some of the world's most pressing infectious diseases.
We have more than a decade of experience contending with some of the world's most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS.
Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.
Our scientists are committed to developing vaccine candidates for some of the world's toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform.
Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.
Novavax, Inc.
is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.
We are seeking a Senior Scientist to support the Formulation Development department and lead a group of energetic scientists.
The qualified individual should have demonstrated proficiency with leading drug substance and drug product formulation development projects to support product development from initial candidate identification through commercialization.
The individual will also bring solid knowledge of biophysical characterization of formulations as well as development of bioanalytical tools for predictive stability of protein nanoparticles.
The candidate will take a leading role in establishing strategy, development, and evaluation in all formulation physicochemical characterizations and drug product formulation development studies.
The candidate will be expected to work efficiently with cross-functional teams and will be expected to take an active role in the professional development of direct reports.
Good understanding FDA and ICH guidelines and practical knowledge with assay validation is required for this position.
The position will be located at our Gaithersburg, MD facility and report to the Senior Director of Formulation Development.
Responsibilities include but are not limited to:
Lead and manage a team of professionals towards the characterization, development, and evaluation of recombinant protein vaccine products.
Design, definition, and execution of scientific formulation activities for preclinical and early clinical studies for the formulation development of solid and liquid drug product presentations.
Scientific Activities including, but not limited to:
Design and execute Quality by Design (QbD) and Design of Experiment (DOE) principles in drug product and process development experimentation.
Develop activities to evaluate formulations, processes, and equipment.
Development of adjuvanted and unadjuvanted formulations of recombinant protein nanoparticle vaccines.
Design lyophilization cycle studies for drug product manufacturing.
Develop SOP documentation for new processes and equipment.
Participate in all scientific development and scale-up activities of drug product processes from bench top to pilot scale and technology transfers.
Activities including, but not limited to:
Review all formulation developed methods and protocols.
Discovery and selection of techniques to solve current formulation issues.
Participation in cross-functional product development team to provide scientific expertise.
Collaboration with other departments to identify equipment, conduct scale-up studies, and support existing products.
Participate in Process Development activities.
Support development of new technologies and enhanced technology capabilities applicable to formulation development and commercialization.
Support in activities and documentation for technology transfer to CMC facilities.
Lead scientific discussion and investigations for all drug substances and drug products being developed.
Provide expert guidance to formulate small and large scale lots of liquid, frozen or lyophilized plasma protein drug candidates.
Authorship of formulation protocols, SOP, batch records, and development reports.
Review both the data generated in the formulation development studies and their resulting reports.
Review and evaluate developed lyophilization cycle processes to manufacture freeze-dried drug products.
Presentation of scientific findings internally and publicly.
Consistently generate innovative and unique solutions to formulation market needs and submit idea disclosures.
Support Regulatory Affairs in IND and BLA submission.
Minimum Requirements:
Requires PhD in relevant field with 6 years relevant scientific experience or a minimum of 10 years relevant scientific experience with a Masters degree.
Requires demonstrated experience in project management with multiple direct reports.
Demonstrated ability to manage a team of scientists, and develop and motivate scientists to achieve results.
Experience in formulation product development, Quality by Design (QbD), Design of Experiment (DOE) processes.
Direct experience and expertise in recombinant protein drug substance synthesis, characterization, evaluations and formulation development.
Demonstrated leadership skills and capable of working collaboratively and cross functionally.
Ability to critically analyze data using statistical tools and to compile and review technical reports.
Ability to define priorities and process to get things done.
Knowledge and experience in GLP and GMP requirements.
Demonstrated expertise with bio/analytical and physicochemical characterizations of proteins, including protein synthesis, structure, stability, aggregation, and solubility is highly desirable.
Ability to work independently with strong problem-solving skills.
Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements.
Strong technical writing skilled supported by scientific publication history.
Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.
Equal Opportunity Employer/Veterans/DisabledNovavax is an equal employment opportunity employer.
Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.
Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.
SummaryLocation:
Gaithersburg, MDType:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
Novavax, Inc (Nasdaq:
NVAX) is a biotechnology company that creates transformational vaccines that address some of the world's most pressing infectious diseases.
We have more than a decade of experience contending with some of the world's most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS.
Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.
Our scientists are committed to developing vaccine candidates for some of the world's toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform.
Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.
Novavax, Inc.
is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.
We are seeking a Senior Scientist to support the Formulation Development department and lead a group of energetic scientists.
The qualified individual should have demonstrated proficiency with leading drug substance and drug product formulation development projects to support product development from initial candidate identification through commercialization.
The individual will also bring solid knowledge of biophysical characterization of formulations as well as development of bioanalytical tools for predictive stability of protein nanoparticles.
The candidate will take a leading role in establishing strategy, development, and evaluation in all formulation physicochemical characterizations and drug product formulation development studies.
The candidate will be expected to work efficiently with cross-functional teams and will be expected to take an active role in the professional development of direct reports.
Good understanding FDA and ICH guidelines and practical knowledge with assay validation is required for this position.
The position will be located at our Gaithersburg, MD facility and report to the Senior Director of Formulation Development.
Responsibilities include but are not limited to:
Lead and manage a team of professionals towards the characterization, development, and evaluation of recombinant protein vaccine products.
Design, definition, and execution of scientific formulation activities for preclinical and early clinical studies for the formulation development of solid and liquid drug product presentations.
Scientific Activities including, but not limited to:
Design and execute Quality by Design (QbD) and Design of Experiment (DOE) principles in drug product and process development experimentation.
Develop activities to evaluate formulations, processes, and equipment.
Development of adjuvanted and unadjuvanted formulations of recombinant protein nanoparticle vaccines.
Design lyophilization cycle studies for drug product manufacturing.
Develop SOP documentation for new processes and equipment.
Participate in all scientific development and scale-up activities of drug product processes from bench top to pilot scale and technology transfers.
Activities including, but not limited to:
Review all formulation developed methods and protocols.
Discovery and selection of techniques to solve current formulation issues.
Participation in cross-functional product development team to provide scientific expertise.
Collaboration with other departments to identify equipment, conduct scale-up studies, and support existing products.
Participate in Process Development activities.
Support development of new technologies and enhanced technology capabilities applicable to formulation development and commercialization.
Support in activities and documentation for technology transfer to CMC facilities.
Lead scientific discussion and investigations for all drug substances and drug products being developed.
Provide expert guidance to formulate small and large scale lots of liquid, frozen or lyophilized plasma protein drug candidates.
Authorship of formulation protocols, SOP, batch records, and development reports.
Review both the data generated in the formulation development studies and their resulting reports.
Review and evaluate developed lyophilization cycle processes to manufacture freeze-dried drug products.
Presentation of scientific findings internally and publicly.
Consistently generate innovative and unique solutions to formulation market needs and submit idea disclosures.
Support Regulatory Affairs in IND and BLA submission.
Minimum Requirements:
Requires PhD in relevant field with 6 years relevant scientific experience or a minimum of 10 years relevant scientific experience with a Masters degree.
Requires demonstrated experience in project management with multiple direct reports.
Demonstrated ability to manage a team of scientists, and develop and motivate scientists to achieve results.
Experience in formulation product development, Quality by Design (QbD), Design of Experiment (DOE) processes.
Direct experience and expertise in recombinant protein drug substance synthesis, characterization, evaluations and formulation development.
Demonstrated leadership skills and capable of working collaboratively and cross functionally.
Ability to critically analyze data using statistical tools and to compile and review technical reports.
Ability to define priorities and process to get things done.
Knowledge and experience in GLP and GMP requirements.
Demonstrated expertise with bio/analytical and physicochemical characterizations of proteins, including protein synthesis, structure, stability, aggregation, and solubility is highly desirable.
Ability to work independently with strong problem-solving skills.
Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements.
Strong technical writing skilled supported by scientific publication history.
Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.
Equal Opportunity Employer/Veterans/DisabledNovavax is an equal employment opportunity employer.
Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.
Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.
SummaryLocation:
Gaithersburg, MDType:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
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