R&D Formulation Sr Scientist I

American Regent; New Albany (OH); On-site; USD 130,000 - 190,000; Full time

Job summary

American Regent is seeking a senior scientist for parenteral drug product development. You will design and execute parenteral formulation studies, align with QbD principles, and develop scalable processes for sterile injectables.

The role includes technology transfer, regulatory interactions, and training of lab personnel to ensure GMP compliance. The candidate will draft development reports and support NDA/ANDA submissions, while collaborating across teams to troubleshoot manufacturing issues

Qualifications

• Requires PhD or MS with extensive pharmaceutical drug product development experience.
• In-depth knowledge of formulation development following QbD principles.
• Experience with sterile injectable products, suspension and freeze-dried formulations is a plus.
• Hands-on skills with analytical instruments (HPLC, Karl Fischer) are preferred.
• Experience in scale-up, tech transfer and regulatory interactions is expected.

Responsibilities

• Design and implement parenteral formulation studies per FDA/ICH guidance.
• Develop scalable manufacturing processes for parenteral products.
• Draft raw material specifications and R&D reports for regulatory submissions.
• Train laboratory personnel and ensure compliance with GMP and safety policies.
• Support regulatory responses to FDA deficiencies and conduct literature searches.

Skills

QbD principles

Formulation development

Sterile injectables

Process development

Regulatory knowledge

Team collaboration

Education

PhD in Pharmaceutical Sciences

MS in Pharmaceutical Drug Product Development

Tools

HPLC

Karl Fischer titrator

Particle size analyzer

Job description

Nature and ScopeResponsible for formulation and process development activities associated with parenteral drug product development following Quality by Design (QbD) principal. Participates in manufacturing process scale-up and technology transfer. Supports trouble shooting of manufacturing issues, ANDA submission and regulatory response to FDA deficiency. Responsible for training of laboratory personnel in areas of expertise.Essential Duties and ResponsibilitiesNothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.Conduct literature search and pre-formulation studies on new generic products.Design and execute parenteral formulation studies in accordance with company procedures and appropriate FDA/ICH guidance.Design and execute laboratory experiments to study material compatibility and evaluate sterilization options.Develop scalable manufacturing process for parenteral drug products.Draft raw material specifications.Write R & D study and product development reports and generate documents in support of regulatory submission.Ensure all work is performed and documented in accordance with existing company policies, procedures, current Good Manufacturing Practices, and health and safety requirements.Perform any other tasks/duties as assigned by management.Education Requirements and QualificationsTo 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.PhD with experience 5 years progressive work experience in pharmaceutical drug product development, or master’s degree plus 10 years progressive work experience in pharmaceutical drug product development required.Broad knowledge of formulation development following QbD principal, formulation characterization, process development, and scale up of sterile injectable products is essential.Experience in development of suspension and freeze dried products is a plus.Hands on skills in analytical instrumentals such as HPLC, particle sizer and Karl-Fischer titrator are a plus.Knowledge of pharmaceutical product lifecycle management is a plus.Excellent organizational, interpersonal and communication skills are required.Proficiency in Microsoft Office Word and Excel is required.Physical Environment and RequirementsPhysically 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 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision.Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.Position requires working in the laboratory as well as sitting.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: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdfKnow Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdfAlert: We’re 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 americanregent.com 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 [e-mail] 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 https://careers.americanregent.com/ 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 [e-mail].