Jobs in the United States

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Added 1 min ago
LC
Project Manager, Cybersecurity
Lee County Government
Fort Myers, FL
- $100,000 to $145,000 USD / year
Lee County is seeking a seasoned cybersecurity professional to lead the County's enterprise cybersecurity program and help protect critical systems, data, and services. This position serves…
Added 1 min ago
LC
Facilities Equipment Manager
LifeSouth Community Blood Centers
Gainesville, FL
- $55,000 to $60,500 USD / year
LifeSouth Community Blood Centers is hiring a Facilities Equipment Manager in Gainesville, FL.
Added 1 min ago
VB
Associate Director, CMC Project Management (Temporary)
Vir Biotechnology
San Francisco, CA
- $78 to $109 USD / hour
This is a temporary staff position based in our San Francisco, California office, with the expectation to be onsite three days per week
Added 1 min ago
Junior Project Manager - 1st Shift (7a-4:30p, $32-$36/hr)
HiFyve
Cedarburg, WI
…manufacturer with a 65+ year history is adding a Junior Project Manager to its tooling division, which designs and builds injection molds for consumer goods, packaging and automotive…
Added 2 mins ago
Key Account Representative
Quikserv, Inc.
Houston, TX
…real authority over pricing negotiations, account-specific program terms, and order management from kickoff through delivery. This role reports to the Inside Sales Manager, and your…
Added 2 mins ago
Director of Manufacturing and Skilled Trades
Virginia Community Colleges
VA
The Director leads program strategy, curriculum development, instructional staffing, facilities and equipment, budgets, enrollment, credential attainment, fiscal sustainability, and…
Added 2 mins ago
Senior Marketing Executive - eCommerce & DTC
VividFront
Cleveland, OH
…performance marketing that demands both creative judgment and technical engineering…
Added 2 mins ago
Physical Plant Manager
Arizona Department of Administration
AZ
The Physical Plant Manager oversees a comprehensive inspection and preventive maintenance program for the Arizona Air National Guard's major physical plant operations. This includes…
Added 2 mins ago
Research Assistant
UT Health San Antonio Staff Positions
San Antonio, TX
Under general supervision, provides routine technical assistance in performing assigned and delegated tasks in support of research projects. Responsibilities include assisting or conducting…
Added 3 mins ago
Site Engineer II
Digital Realty Global
Garland, TX
…more of our data center properties reporting directly to the Manager Engineering Operations. The Site Engineer II will have experience in mission critical infrastructure, including…
Added 3 mins ago
Site Engineer II
Digital Realty Global
Richardson, TX
…more of our data center properties reporting directly to the Manager Engineering Operations. The Site Engineer II will have experience in mission critical infrastructure, including…
Added 3 mins ago
Product Manager, Cross-Border Bill Pay
Western Union, LLC
Denver, CO
Product Manager, Cross-Border Bill Pay · As our Product Manager, Cross-Border Bill Pay, you’ll play a key role in developing and enhancing our international bill payment capabilities
Added 4 mins ago
Program Manager
Oshkosh Corporation
New Hudson, MI
Defense programs are managed by utilizing resources from functional engineering and manufacturing groups. Responsibilities of the Program Manager is customer satisfaction and business unit…
Added 4 mins ago
Senior Manager, Software Development
CVS Health
Remote, United States
Take ownership of the next phase of an engineering transformation already delivering results. We have modernized critical systems and shipped AI features that providers use. This role…
Added 4 mins ago
AC
Production Planning And Scheduling Manager
Aston Carter
Riverside, CA
- $126,000 to $140,000 USD / year
Maintain planning-owned ERP parameters while coordinating closely with Engineering for technical BOM ownership and Procurement for supplier commitments.
Added 4 mins ago
AC
Account Manager
Aston Carter
Saint Paul, MN
- $24.04 to $28.85 USD / hour
We are seeking a customer-focused and detail-oriented Account Manager to support existing business-to-business (B2B) customer accounts through pricing, quoting, order management, and daily…
Added 4 mins ago
Estimator
LOC Performance Products, Inc
Auburn Hills, MI
Must possess the ability to explain complex concepts in a way that makes sense to someone less knowledgeable about the topic
Added 4 mins ago
Technical Specialist
Alten USA
Sterling Heights, MI
The QTP Specialist’s primary interface is with the Project and Platform/Modules CVE, Quality, Cost, Technical, *Planning (QCTP) Manager and Project Management Office (PMO) QTP Manager
Added 4 mins ago
Manufacturing Execution Engineer - General Assembly Optimization
General Motors
Warren, MI
Own engineering deliverable status for Program Execution Teams and Program Quality Readiness Reviews.
Added 4 mins ago
Senior Manager, Software Release Program Management
General Motors
Warren, MI · Milford, MI
Hire, coach, and develop technical program managers; establish clear ownership across release programs. This position will lead a team of 10-20.
Added 4 mins ago
Senior Quality, Reliability, & Durability Engineer
General Motors
Warren, MI
Turn customer and warranty evidence into engineering action. As the QRD Engineer for engines, electric motors, power electronics and charging inlets, you’ll guide teams from field-signal…
Added 4 mins ago
VA&AE Strategic Business and Operations Manager
Ford Motor Company
Dearborn, MI
The Strategic Business & Operations Manager for Vehicle Architecture and Attribute Engineering (VA&AE) is a high-impact leadership role designed for an exceptional candidate who blends…
Added 5 mins ago
Technical Project Manager Electronics Rack PDU En
KLATencor Corporation
Ann Arbor, MI
…delivering high-impact work across your area of expertise. Technical Project Managers are core to KLA's technology, while we do not currently have an opening, we are always building our…
Added 5 mins ago
Product Owner
Leidos
Ann Arbor, MI
…(M-SHORAD) aligned solutions. This role will report to the Program Manager responsible for full kill chain C-UAS sensing, decision aids, and effectors. As a product owner you will help…
Added 5 mins ago
Sub Section Manager - Embedded Software
GE Aerospace
Grand Rapids, MI
Are you an Embedded Software Engineering Manager who loves leading teams and working on high-assurance embedded systems? If so, GE Aerospace Defense and Systems wants you to join their…

Lupin

Sr. Manager, Product Development

Somerset, NJ, FL, United States

$100,000 to $130,000 USD / year

Apply on careers.lupin.com About employer

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Job details

Pay: $100,000 to $130,000 USD / year
Apply by: Feb 6, 2027
Posting language: English
Posted: Nov 13, 2026

Original job description

Header

Turn science into impact. Lead the CMC and technical strategy behind innovative Women’s Health products from development and scale-up through FDA submission and commercialization

Job Description

The Senior Manager, Product Development will serve as the CMC and Technical Lead for Women’s Health development programs, including long-acting implants and intrauterine systems. This role will lead product development, CMC strategy, manufacturing support, external partner execution, regulatory readiness, and ANDA submission activities.

Key Responsibilities

Lead technical development activities for Women’s Health products (i.e., implants and intrauterine systems).
Develop and execute formulation, process development, scale-up, and manufacturing strategies.
Drive scientific investigations, data interpretation, root-cause evaluation, and technical decision-making.
Support programs through registration, validation, regulatory submission, and commercialization readiness.
Develop and execute CMC strategies supporting ANDA and other applicable regulatory submissions.
Author, review, and approve scientific reports, development reports, technical assessments, risk evaluations, and regulatory responses.
Support FDA interactions, Controlled Correspondence submissions, information requests, and deficiency responses.
Partner with Regulatory Affairs and Quality to maintain submission readiness and regulatory compliance.
Lead the preparation, authoring, review, compilation, and readiness assessment of ANDA CMC packages.
Coordinate Module 3 documentation, pharmaceutical development reports, manufacturing process descriptions, comparability assessments, technical justifications, stability documentation, control strategy content, and device-related technical documentation.
Identify CMC content and data gaps, assign closure actions, and drive documents through cross-functional review and approval.
Support document finalization, regulatory publishing handoff, ANDA filing, and post-submission CMC responses.
Provide technical leadership for engineering, pilot, exhibit, registration, and validation batch activities.
Support investigations, deviations, change controls, CAPAs, manufacturing troubleshooting, and process optimization.
Review manufacturing protocols, batch records, technical reports, and validation documentation.
Collaborate with CMOs to ensure successful and compliant execution of development and registration activities.
Serve as the technical liaison for CMOs, analytical laboratories, device suppliers, material suppliers, and development partners.
Support governance reviews, Joint Steering Committees, vendor meetings, and program-management activities.
Lead multidisciplinary teams and mentor scientists.

Qualification and Experience

Ph.D. in Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline with 8+ years of relevant pharmaceutical development experience; or
M.S. in a related scientific discipline with 12+ years of relevant pharmaceutical development experience.
Demonstrated experience leading pharmaceutical product development and CMC activities for complex dosage forms or drug-device combination products. Required Skills
Complex generic or specialty pharmaceutical product development.
CMC strategy, technical authoring, and regulatory submission support.
Manufacturing process development, scale-up, technology transfer, and validation.
Technical investigations, change controls, risk assessments, and scientific documentation.
External partner, CMO, and vendor management.
Cross-functional project leadership and effective communication with stakeholders. Preferred Qualifications
Long-acting implants, intrauterine systems, or sustained- and controlled-release technologies.
Silicone-based drug delivery systems or polymer-based delivery systems.
Drug-device combination product development and submission experience.
IVRT or IVPT method strategy and data interpretation.
Direct experience with FDA ANDA submissions and post-submission responses.
Experience working with global development teams and external manufacturing partners.

The anticipated annual base salary range for this position in New Jersey is $100,000 to $130,000, plus a discretionary performance bonus (based upon eligibility). The final salary offered to a successful candidate may vary and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, the type and length of experience within the industry, skillset, education, business needs, etc. Lupin is a multi-state employer, and this salary range may not reflect positions that work in other states

Competencies

Collaboration Customer Centricity Developing Talent Innovation & Creativity Process Excellence Result Orientation Stakeholder Management Strategic Agility

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Jobs in the United States