Nature and Scope 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 inje…
This entry level position is a member of the Manufacturing Team. The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with com…
As an essential business, Anomatic produces innovative and sustainable packaging for today’s biggest brands. By leveraging over five decades of manufacturing expertise and employing an extensive technologies portfolio, w…
HELP US BRING THE GIFT OF HEALTH TO LIFE. Working at Pharmavite is an experience like no other. With a focus on complete nutrition for all, each endeavor is urgent and every day counts. You'll have the opportunity to wor…
Skills: Equipment Operation, Troubleshooting, cGMP Compliance, Quality Control, Material Handling
HELP US BRING THE GIFT OF HEALTH TO LIFE. Working at Pharmavite is an experience like no other. With a focus on complete nutrition for all, each endeavor is urgent and every day counts. You'll have the opportunity to wor…
Skills: Team Leadership, Warehouse Management, Forklift Operation, Root Cause Analysis, Continuous Improvement
Current CVG employees, please click HERE to login and apply. POSITION SUMMARY The Finance Manager – Global Seats supports the growth and operational efficiency of CVG’s Global Seats Division, reporting directly to the Se…
HELP US BRING THE GIFT OF HEALTH TO LIFE. Working at Pharmavite is an experience like no other. With a focus on complete nutrition for all, each endeavor is urgent and every day counts. You'll have the opportunity to wor…
Description Reports to – Shipping Manager Job Summary: Reporting to the Shipping Manager, this position has primary responsibility for all functions and paperwork relating to pulling, packing and shipping material out of…
Nature and Scope Working as part of a multi-disciplinary team, the Production Engineer II must possess the ability to manage multiple tasks simultaneously, manage projects and project timelines, and create project specif…
HELP US BRING THE GIFT OF HEALTH TO LIFE. Working at Pharmavite is an experience like no other. With a focus on complete nutrition for all, each endeavor is urgent and every day counts. You'll have the opportunity to wor…
Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to c…
As an essential business, Anomatic produces innovative and sustainable packaging for today’s biggest brands. By leveraging over five decades of manufacturing expertise and employing an extensive technologies portfolio, w…
Skills: Leadership, Lean Manufacturing, Organizational Skills, Communication Skills, Microsoft Windows
Career CategoryEngineeringJob Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with seriou…
HELP US BRING THE GIFT OF HEALTH TO LIFE. Working at Pharmavite is an experience like no other. With a focus on complete nutrition for all, each endeavor is urgent and every day counts. You'll have the opportunity to wor…
Career CategoryEngineeringJob Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with seriou…
HELP US BRING THE GIFT OF HEALTH TO LIFE. Working at Pharmavite is an experience like no other. With a focus on complete nutrition for all, each endeavor is urgent and every day counts. You'll have the opportunity to wor…
Skills: Forklift Operation, Warehouse Management, Inventory Control, Shipping and Receiving, Data Entry
Accelerate the possible by joining a winning Amcor team that’s transforming the packaging industry and improving lives around the world. At Amcor, we unpack possibility through our innovative and responsible packaging to…
Logistics at full potential. At GXO, we’re constantly looking for talented individuals at all levels who can deliver the caliber of service our company requires. You know that a positive work environment creates happy em…
Skills: Warehouse Operations, Team Supervision, Training and Coaching, Microsoft Office, Continuous Improvement
HELP US BRING THE GIFT OF HEALTH TO LIFE. Working at Pharmavite is an experience like no other. With a focus on complete nutrition for all, each endeavor is urgent and every day counts. You'll have the opportunity to wor…
Skills: Process Optimization, Root Cause Analysis, Cleaning Validation, Equipment Qualification, Technical Writing
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Full-time
postgraduate degree
Posted 68d ago
~40 hrs/week
Responsibilities
Lead the end-to-end strategy and execution of pharmaceutical drug product development, focusing on innovative injectable dosage forms from ideation to commercial launch. Oversee the preparation of critical CMC documentation and provide technical leadership for regulatory submissions such as NDAs and ANDAs.
Requirements
Requires a Ph.D. in Life Sciences with at least 10 years of experience in formulation and process development and 7+ years of leadership experience. Must possess deep expertise in parenteral drug delivery and global regulatory requirements.
Full job description
Nature and Scope
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.
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 [email protected] 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 [email protected].
Related keywords
PharmaceuticalsInjectablesCMCQbDNDAANDA505(b)(2)NADAParenteralLyophilized ProductsSuspensionsComplex GenericsFirst-to-FileFirst-to-LaunchDrug Delivery PlatformsTechnical Transfer
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 nationwide.
American Regent continues to position its business for sustainable growth, with significant investments in the modernization and expansion of our U.S. manufacturing sites. These enhancements are expected to strengthen our business and represents our commitment to the ongoing success of our company and its employees.
Supporting patient health is our guiding principle and our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of brand and generic specialty injectables.
Offices: 5 Ramsey Rd, Shirley, New York 11967, US · 6610 New Albany Rd E, New Albany, Ohio 43054, US · 536 Vanguard Way, Brea, California 92821, US
How many Manufacturing jobs are open in New Albany, OH right now?
There are currently 248 open manufacturing positions in New Albany, OH listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Manufacturing roles in New Albany, OH?
Companies currently hiring include Pharmavite, Amgen, American Regent, Inc., kdc/one, Anomatic Corporation, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Manufacturing jobs in New Albany, OH?
Yes — 5 of the 248 open manufacturing positions offer remote or hybrid work (0 remote, 5 hybrid).
How do I apply for Manufacturing jobs in New Albany, OH?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.