... 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 ...

94 American Regent Process Engineer Jobs Hiring Near You
... 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 ...
Sterilization Technician I (1:30 pm-10 pm)
Hilliard, OH · On-site
$15.25 - $19.50/hr
... 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 ...
Sterilization Technician I (1:30 pm-10 pm)
Hilliard, OH · On-site
$15.25 - $19.50/hr
... 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 ...
... 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 ...
... 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 ...
... 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 ...
... 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 ...
Sterilization Technician I (1:30 pm-10 pm)
Hilliard, OH · On-site
$15.25 - $19.50/hr
... 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 ...
Sterilization Technician I (1:30 pm-10 pm)
Hilliard, OH · On-site
$15.25 - $19.50/hr
... 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 ...
... 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 ...
... 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 ...
... processing area. * Collaborate with Maintenance/Engineering to perform advanced repairs ... American Regent celebrates diversity and we are committed to creating an inclusive environment for ...
... processing area. * Collaborate with Maintenance/Engineering to perform advanced repairs ... American Regent celebrates diversity and we are committed to creating an inclusive environment for ...
... processing area. * Collaborate with Maintenance/Engineering to perform advanced repairs ... American Regent celebrates diversity and we are committed to creating an inclusive environment for ...
... processing area. * Collaborate with Maintenance/Engineering to perform advanced repairs ... American Regent celebrates diversity and we are committed to creating an inclusive environment for ...
QA Specialist, Aseptic Manufacturing Oversight
Shirley, NY · On-site
$70K - $80K/yr
Nature and Scope The QA Specialist, Aseptic Manufacturing Oversight ensures that American Regent ... The role is responsible for providing oversight for Aseptic Processing Area (APA) in relation to ...
QA Specialist, Aseptic Manufacturing Oversight
Shirley, NY · On-site
$70K - $80K/yr
Nature and Scope The QA Specialist, Aseptic Manufacturing Oversight ensures that American Regent ... The role is responsible for providing oversight for Aseptic Processing Area (APA) in relation to ...
QC Chemist I
Shirley, NY · On-site
$33.70 - $37/hr
... process, and finished product samples accurately and efficiently to determine chemical identity, potency and purity of pharmaceutical products manufactured by American Regent, Inc. The QC Chemist I ...
QC Chemist I
Shirley, NY · On-site
$33.70 - $37/hr
... process, and finished product samples accurately and efficiently to determine chemical identity, potency and purity of pharmaceutical products manufactured by American Regent, Inc. The QC Chemist I ...
Material Quality Inspector
Shirley, NY · On-site
$21.06 - $23/hr
... 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 ...
Material Quality Inspector
Shirley, NY · On-site
$21.06 - $23/hr
... 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 ...
QC Chemist IV
Shirley, NY · On-site
$117K - $125K/yr
... process, and finished product samples accurately and efficiently to determine chemical identity, potency and purity of pharmaceutical products manufactured by American Regent, Inc. The QC Chemist IV ...
QC Chemist IV
Shirley, NY · On-site
$117K - $125K/yr
... process, and finished product samples accurately and efficiently to determine chemical identity, potency and purity of pharmaceutical products manufactured by American Regent, Inc. The QC Chemist IV ...
QC Chemist I
Shirley, NY · On-site
$33.70 - $37/hr
... process, and finished product samples accurately and efficiently to determine chemical identity, potency and purity of pharmaceutical products manufactured by American Regent, Inc. The QC Chemist I ...
QC Chemist I
Shirley, NY · On-site
$33.70 - $37/hr
... process, and finished product samples accurately and efficiently to determine chemical identity, potency and purity of pharmaceutical products manufactured by American Regent, Inc. The QC Chemist I ...
QA Specialist, Aseptic Manufacturing Oversight
Shirley, NY · On-site
$70K - $80K/yr
Nature and Scope The QA Specialist, Aseptic Manufacturing Oversight ensures that American Regent ... The role is responsible for providing oversight for Aseptic Processing Area (APA) in relation to ...
QA Specialist, Aseptic Manufacturing Oversight
Shirley, NY · On-site
$70K - $80K/yr
Nature and Scope The QA Specialist, Aseptic Manufacturing Oversight ensures that American Regent ... The role is responsible for providing oversight for Aseptic Processing Area (APA) in relation to ...
Material Quality Inspector
Shirley, NY · On-site
$21.06 - $23/hr
... 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 ...
Material Quality Inspector
Shirley, NY · On-site
$21.06 - $23/hr
... 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 ...
Manual Inspector Trainee (3pm-11:30pm)
Shirley, NY · On-site
$19.27/hr
... 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 ...
Manual Inspector Trainee (3pm-11:30pm)
Shirley, NY · On-site
$19.27/hr
... 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 ...
Equipment Prep Operator I (7am-3:30pm)
Shirley, NY · On-site
$23.76/hr
American Regent also offers a competitive total rewards package which includes healthcare, life ... Our recruiting process includes multiple in person and/or video interviews and assessments. If you ...
Equipment Prep Operator I (7am-3:30pm)
Shirley, NY · On-site
$23.76/hr
American Regent also offers a competitive total rewards package which includes healthcare, life ... Our recruiting process includes multiple in person and/or video interviews and assessments. If you ...
QC Chemist IV
Shirley, NY · On-site
$117K - $125K/yr
... process, and finished product samples accurately and efficiently to determine chemical identity, potency and purity of pharmaceutical products manufactured by American Regent, Inc. The QC Chemist IV ...
QC Chemist IV
Shirley, NY · On-site
$117K - $125K/yr
... process, and finished product samples accurately and efficiently to determine chemical identity, potency and purity of pharmaceutical products manufactured by American Regent, Inc. The QC Chemist IV ...
Material Handler (11pm-7:30am)
Shirley, NY · On-site
$20.55/hr
... 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 ...
Material Handler (11pm-7:30am)
Shirley, NY · On-site
$20.55/hr
... 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 ...
Packaging/Inspection Technician IV (3pm-11:30pm)
Shirley, NY · On-site
$33.71 - $39/hr
American Regent also offers a competitive total rewards package which includes healthcare, life ... Our recruiting process includes multiple in person and/or video interviews and assessments. If you ...
Packaging/Inspection Technician IV (3pm-11:30pm)
Shirley, NY · On-site
$33.71 - $39/hr
American Regent also offers a competitive total rewards package which includes healthcare, life ... Our recruiting process includes multiple in person and/or video interviews and assessments. If you ...
American Regent Jobs Information
Do workers at American Regent get paid breaks?
83% of people say they get paid breaks.
Based on data from 6 people who took the Breakroom Quiz between January 2025 and July 2026.
Does American Regent pay people when they’re sick?
71% of people say they would get paid if they were sick but scheduled to work.
Based on data from 7 people who took the Breakroom Quiz between January 2025 and June 2026.
At American Regent, are sick days and vacation days separate paid time off?
100% of people say they have to use vacation days when they’re out sick.
Based on data from 9 people who took the Breakroom Quiz between June 2025 and July 2026.
Is the health insurance from American Regent affordable enough for their workers?
100% of people say the health insurance costs are okay
Based on data from 9 people who took the Breakroom Quiz between April 2025 and June 2026.
Do people get paid time off at American Regent?
100% of people say they get paid time off.
Based on data from 9 people who took the Breakroom Quiz between June 2025 and July 2026.
Do workers at American Regent worry about hours?
100% of people report they don’t worry about getting enough hours.
Based on data from 5 people who took the Breakroom Quiz between January 2025 and August 2025.
How easy is it to get time off at American Regent?
100% of people report it’s easy to get time off.
Based on data from 8 people who took the Breakroom Quiz between January 2025 and June 2026.
Do American Regent managers change schedules at the last minute?
100% of people say their manager doesn’t change their shift schedule at the last minute.
Based on data from 5 people who took the Breakroom Quiz between January 2025 and August 2025.
Do jobs at American Regent spill into time workers aren’t paid for?
0% of people report that their job takes up time that they don’t get paid for.
Based on data from 5 people who took the Breakroom Quiz between January 2025 and August 2025.
How easy is it to take sick days at American Regent?
83% of people report that it’s easy to take time off if they are sick.
Based on data from 12 people who took the Breakroom Quiz between January 2025 and July 2026.
Do people at American Regent feel treated with respect by their managers?
83% of people say they’re treated with respect by their managers.
Based on data from 12 people who took the Breakroom Quiz between January 2025 and July 2026.
Do people at American Regent get to take their breaks without interruption?
92% of people report that they get to take their breaks without interruption.
Based on data from 12 people who took the Breakroom Quiz between January 2025 and July 2026.
Is it stressful to work at American Regent?
33% of people say they often feel stressed out at work.
Based on data from 12 people who took the Breakroom Quiz between January 2025 and July 2026.
Do people at American Regent enjoy their jobs?
40% of people report they don’t enjoy their job.
Based on data from 10 people who took the Breakroom Quiz between January 2025 and July 2026.
Do people at American Regent recommend working with their team?
67% of people report that they would recommend working with their immediate team to a friend.
Based on data from 12 people who took the Breakroom Quiz between January 2025 and July 2026.
Do people get enough training when they start at American Regent?
83% of people report they got enough training when they started working here.
Based on data from 12 people who took the Breakroom Quiz between January 2025 and July 2026.
Do people get support to advance at American Regent?
In the last year, 67% of people report being given support to advance their career here.
Based on data from 9 people who took the Breakroom Quiz between January 2025 and July 2026.
Do people think American Regent’s headquarters understands what’s happening where they work?
90% of people think that this employer’s headquarters or owners don’t have a good understanding of what’s really happening where they work.
Based on data from 10 people who took the Breakroom Quiz between February 2025 and July 2026.
Do workers feel well informed about how American Regent is doing?
50% of people feel that they aren’t kept well informed about how the company is doing as a whole.
Based on data from 8 people who took the Breakroom Quiz between January 2025 and July 2026.

Full-time
Re-posted 7 days ago
American Regent rating
7.2
Based on 12 frontline employees who took The Breakroom Quiz
70th of 86 rated pharmaceutical
Job description
The R&D Product Development Director is a pivotal leadership role responsible for the end-to-end strategy and execution of pharmaceutical drug product development, with a primary focus on innovative injectable dosage forms. This role oversees programs from ideation through commercial launch, ensuring scientific rigor, regulatory compliance, and alignment with enterprise growth objectives.
This position requires deep scientific expertise across complex formulations, CMC strategy, analytical and bioanalytical testing, combined with strong business acumen and cross-functional leadership. The Director serves as a key strategic partner in advancing the company's portfolio, collaborating closely with Portfolio Management, Clinical, Regulatory Affairs, Manufacturing, and Commercial teams to optimize execution, accelerate development timelines, and pioneer differentiated drug delivery solutions.
Essential Duties and Responsibilities
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
- Lead the development and execution of comprehensive pharmaceutical development strategies, ensuring all R&D programs meet global regulatory standards and corporate objectives.
- Oversee the preparation, review, and approval of critical pharmaceutical development documentation, including Technical Transfer Documents, Product Development Reports (PDRs), CMC sections, and regulatory submission materials supporting clinical, registration, and commercial batches.
- Apply Quality by Design (QbD) principles and risk-based methodologies to accelerate development timelines while maintaining scientific excellence and compliance.
- Serve as the scientific authority in Portfolio Management Committee meetings, providing technical leadership and strategic input for NDAs, 505(b)(2) applications, ANDAs, and NADAs.
- Maintain expert-level knowledge of parenteral drug delivery technologies and relevant patent landscapes; proactively contribute to intellectual property strategy and differentiation initiatives.
- Develop and execute long-term R&D strategies aligned with corporate growth objectives and emerging industry trends in injectable and complex dosage forms.
- Identify and advance 505(b)(2) opportunities to create differentiated, value-added formulations for both new and existing products.
- Partner with Development, Medical, Commercial, Regulatory, and Manufacturing teams to build a commercially viable and strategically differentiated product pipeline.
- Contribute to the Scientific Affairs leadership team by shaping and executing the mission, vision, and operational priorities of the R&D organization.
- Recruit, mentor, and lead a high-performing technical organization focused on complex generics, First-to-File (FTF), and First-to-Launch (FTL) parenteral products.
- Establish and champion robust talent development and succession planning processes, fostering a culture of accountability, innovation, and continuous professional growth.
- 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.
- Ph.D. in Life Sciences (Chemistry or Pharmaceutical Science concentration) required.
- Minimum of 10 years' in formulation, analytical, and process development with a proven track record with complex molecules, including solutions, lyophilized products, suspensions, and novel drug delivery platforms.
- 7+ years of demonstrated leadership experience managing a team.
- Deep understanding of the drug discovery lifecycle and global regulatory requirements. Experience in a start-up biotech environment and familiarity with advanced drug development platforms would be a plus.
- Exceptional technical writing and interpersonal skills; ability to influence at the executive level.
- Excellent oral and written communication skills.
- Ability to prioritize and perform multiple tasks simultaneously.
- Ability to make decisions independently and with appropriate input.
- Ability to work well in a matrix environment, particularly with QA/QC, Manufacturing Operations, Project Management and Regulatory Affairs.
- Flexibility in adapting to multiple therapeutic areas and/or projects interchangeably.
- Strong computer skills (Word, Excel, PowerPoint, and Outlook).
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.pdf
- Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
- Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
Alert: 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 jrossini@americanregent.com 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 hrtalentacquisition@americanregent.com.
What American Regent employees say
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Benefits
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About American Regent
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
501 - 1,000 Employees
Headquarters location
Shirley, NY, US
Year founded
1910