R&D Associate Scientist II

New Albany, OH - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Nature and Scope

Responsible for formulation and process development activities associated with parenteral drug product development. Participates in scale-up of manufacturing process.

Essential Duties and Responsibilities

Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time.

Conduct laboratory experiments with minimal supervision to support formulation and process development of injectables Execute laboratory studies for characterization stability studies per ICH guidelines component selection and scale-up activities Execute and support the formulation team on experiments to support the selection of process parameters and development of manufacturing process.
Prepare formulations to support analytical method development.
Draft protocols/reports on the formulation development experiments and deliver data presentations.
Assist in the general operation of the R & D formulation laboratory including maintenance of Standard Operating Procedures (SOPs) and equipment validation or maintenance.
Maintain clean and safe work environment in the laboratory.
Ensure all work is performed and documented in accordance with existing company policies procedures current Good Manufacturing Practices and health & safety requirements.
Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill and/or ability required.

B.S. in Pharmaceutical Science Chemistry Chemical Engineering or equivalent required.
2-3 years or for M.S. 0-2 year of experience in drug product development required.
Hands on skills in analytical instrumentals such as HPLC particle sizer and Karl Fisher titrator is a plus.
Excellent organizational interpersonal and communication skills required.
Proficiency in Microsoft Office Word and Excel is required.
Ability to work overtime as needed.

Physical Environment and Requirements

Physically able to wear laboratory protective gowning and equipment including but not limited to gowning goggles face shields respirators and protective gloves. PPE and Respirators are essential for the health and safety of employees.

Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.

Position requires working in the laboratory as well as sitting.

Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status or protected veteran status.

Applicants have rights under Federal Employment Laws.

FMLA poster: Your Rights: Know Your Rights: Workplace discrimination is illegal ()
Employee Polygraph Protection Act: Were aware of individuals impersonating our staff to target job seekers. Please note:
All legitimate communication will come directly from a verified ARI recruiter either by phone or via an email address.
Our recruiting process includes multiple in person and/or video interviews and assessments.
If you are unsure about the legitimacy of a message contact John Rossini at before responding.
We never request payment bank information or personal financial details during our offer process.
Your security is important to us and we encourage you to stay vigilant when job searching.
American Regent Inc. endeavors to make accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process please email .

Required Experience:

Nature and ScopeResponsible for formulation and process development activities associated with parenteral drug product development. Participates in scale-up of manufacturing process.Essential Duties and ResponsibilitiesNothing in this job description restricts managements right to assign or reassign...

Nature and Scope

Responsible for formulation and process development activities associated with parenteral drug product development. Participates in scale-up of manufacturing process.

Essential Duties and Responsibilities

Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time.

Conduct laboratory experiments with minimal supervision to support formulation and process development of injectables Execute laboratory studies for characterization stability studies per ICH guidelines component selection and scale-up activities Execute and support the formulation team on experiments to support the selection of process parameters and development of manufacturing process.
Prepare formulations to support analytical method development.
Draft protocols/reports on the formulation development experiments and deliver data presentations.
Assist in the general operation of the R & D formulation laboratory including maintenance of Standard Operating Procedures (SOPs) and equipment validation or maintenance.
Maintain clean and safe work environment in the laboratory.
Ensure all work is performed and documented in accordance with existing company policies procedures current Good Manufacturing Practices and health & safety requirements.
Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

B.S. in Pharmaceutical Science Chemistry Chemical Engineering or equivalent required.
2-3 years or for M.S. 0-2 year of experience in drug product development required.
Hands on skills in analytical instrumentals such as HPLC particle sizer and Karl Fisher titrator is a plus.
Excellent organizational interpersonal and communication skills required.
Proficiency in Microsoft Office Word and Excel is required.
Ability to work overtime as needed.

Physical Environment and Requirements

Physically able to wear laboratory protective gowning and equipment including but not limited to gowning goggles face shields respirators and protective gloves. PPE and Respirators are essential for the health and safety of employees.

Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.

Position requires working in the laboratory as well as sitting.

Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.

Applicants have rights under Federal Employment Laws.

FMLA poster: Your Rights: Know Your Rights: Workplace discrimination is illegal ()
Employee Polygraph Protection Act: Were aware of individuals impersonating our staff to target job seekers. Please note:
All legitimate communication will come directly from a verified ARI recruiter either by phone or via an email address.
Our recruiting process includes multiple in person and/or video interviews and assessments.
If you are unsure about the legitimacy of a message contact John Rossini at before responding.
We never request payment bank information or personal financial details during our offer process.
Your security is important to us and we encourage you to stay vigilant when job searching.
American Regent Inc. endeavors to make accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process please email .

Required Experience:

Key Skills

Laboratory Experience
Vendor Management
Design Controls
C/C++
FDA Regulations
Intellectual Property Law
ISO 13485
Research Experience
SolidWorks
Research & Development
Internet Of Things
Product Development

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About Company

American Regent

American Regent, Inc, a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics and hospitals across the United States and Canada. We have locations in New York, Ohio, and Pennsylvania and sales territories ... View more

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