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DH
Distribution Clerk I
Denver Health and Hospital Authority
Denver, CO
- $21 to $24.44 USD / hour
Determines necessary action in situations arising during the absence of the manager. Establishes priorities and coordinates work activities (i.e. transportation with supply deliveries) to…
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Manager, Government Affairs
Gilead Sciences, Inc.
WA
As Manager, Government Affairs, you will be an integral part of a fast-paced, highly collaborative Federal Government Affairs (FGA) team, partnering with Government Affairs & Policy and…
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Rehabilitation Case Manager (RCM)
LEARNING SERVICES CORPORATION
Creedmoor, NC
Must have the ability to travel and/or operate a vehicle for up to 30% of the time spent working in this position
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RB
Resident Service Coordinator - Part Time
Rogerson Brand
Roslindale, MA
- $20 to $22 USD / hour
- Part-time
13. Work closely with Property Manager and Administrative Assistant with annual recertification and waitlist updates. Orient new residents to the building, apartment, social opportunities,…
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Patient Relations Representative - Harbour View Medical Center
Bon Secours Mercy Health Inc
Suffolk, VA
Must possess and maintain a valid, active driver’s license
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LC
Assistant Manager
Links Car Wash
Fort Worth, TX
- $14 to $18 USD / hour
The Assistant Manager supports the daily operations of a high-volume car wash facility. This leadership role is responsible for assisting with site operations, customer service excellence,…
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CH
Pharmacy Intern
CVS Health
Willingboro, NJ
- $20 USD / hour
Must possess or be in process of obtaining valid intern and/or technician licensure as required
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Foreign Pharmacy Grad - International Pharmacy Intern
CVS Health
Fayetteville, NC
- $30 to $42 USD / hour
…opportunities for you to learn and grow professionally. In our programs, you’ll be immersed in a culture of continuous improvement, with the goal of changing health care for the…
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Foreign Pharmacy Grad - International Pharmacy Intern
CVS Health
Fayetteville, NC
- $30 to $42 USD / hour
…opportunities for you to learn and grow professionally. In our programs, you’ll be immersed in a culture of continuous improvement, with the goal of changing health care for the…
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CH
Foreign Pharmacy Grad - International Pharmacy Intern
CVS Health
Fayetteville, NC
- $30 to $42 USD / hour
…opportunities for you to learn and grow professionally. In our programs, you’ll be immersed in a culture of continuous improvement, with the goal of changing health care for the…
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Pharmacy Technician
CVS Health
Johns Island, SC
- $16 to $24 USD / hour
…necessary requirements, duties may be restricted by the Pharmacy…
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Foreign Pharmacy Grad - International Pharmacy Intern
CVS Health
Cameron, NC
- $30 to $42 USD / hour
…opportunities for you to learn and grow professionally. In our programs, you’ll be immersed in a culture of continuous improvement, with the goal of changing health care for the…
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Foreign Pharmacy Grad - International Pharmacy Intern
CVS Health
Aberdeen, NC
- $30 to $42 USD / hour
…opportunities for you to learn and grow professionally. In our programs, you’ll be immersed in a culture of continuous improvement, with the goal of changing health care for the…
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Pharmacy Technician
CVS Health
Staunton, VA
- $16 to $24 USD / hour
…necessary requirements, duties may be restricted by the Pharmacy…
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Pharmacy Technician
CVS Health
Columbia, SC
- $16 to $24 USD / hour
…Your Pharmacy Technician duties will be restricted by your manager at first until you complete all necessary requirements. Once you satisfy all requirements and expand your Pharmacy…
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Pharmacy Technician
CVS Health
Peoria, AZ
- $17.15 to $27.15 USD / hour
…necessary requirements, duties may be restricted by the Pharmacy…
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Pharmacy Technician
CVS Health
Chandler, AZ
- $17.15 to $27.15 USD / hour
…necessary requirements, duties may be restricted by the Pharmacy…
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Staff Pharmacist FT
CVS Health
Tucson, AZ
- $60 to $76 USD / hour
…care for our patients. In addition to supporting the Pharmacy Manager in leading and directing your Pharmacy Technician Support Staff, you are accountable for supporting the management,…
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Staff Pharmacist 9293
CVS Health
Apache Junction, AZ
- $60 to $76 USD / hour
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Pharmacy Technician
CVS Health
Stone Mountain, GA
- $16.5 to $25 USD / hour
…necessary requirements, duties may be restricted by the Pharmacy…
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Pharmacy Technician
CVS Health
Columbus, GA
- $16 to $24 USD / hour
…necessary requirements, duties may be restricted by the Pharmacy…
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Pharmacy Technician
CVS Health
Jeffersonville, IN
- $16.5 to $25 USD / hour
…necessary requirements, duties may be restricted by the Pharmacy…
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Pharmacy Technician
CVS Health
Smyrna, TN
- $16 to $24 USD / hour
…Your Pharmacy Technician duties will be restricted by your manager at first until you complete all necessary requirements. Once you satisfy all requirements and expand your Pharmacy…
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Shift Supervisor
CVS Health
Smyrna, TN
- $16 to $23 USD / hour
…through a focus on excellent customer service. When there is no manager or Operations Supervisor onsite, the Shift Supervisor leads the store staff, ensures that store operations run…
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Shift Supervisor
CVS Health
Evansville, IN
- $16 to $23 USD / hour
…through a focus on excellent customer service. When there is no manager or Operations Supervisor onsite, the Shift Supervisor leads the store staff, ensures that store operations run…

Lupin

Sr. Manager, Product Development

Somerset, NJ, FL, United States

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

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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