About the Role
Reporting to the Senior Customer Service Manager, the Customer Service Operations Analyst will serve as a key bridge between commercial operations, customer service, supply chain, and data analytics. This role combines order management and 3PL execution with reporting, analytics and dashboards that help Sales and Supply Chain monitor performance and resolve issues quickly. The position requires an understanding of pharmaceutical distribution practices, ERP systems, and analytics tools, along with strong communication and problem-solving skills.
Responsibilities
Customer Support & Relationship Management
Serve as a primary point of contact for customers, wholesalers, distributors, specialty pharmacies, and healthcare providers regarding orders, product availability, shipments, and returns.
Maintain strong relationships with customers and internal stakeholders (Sales, Finance, Operations, Regulatory, Quality, and IT).
Communicate proactively regarding order status, delays, product allocations, and launch readiness.
Manage new customer setup, contract alignment, and master data accuracy within ERP and revenue management systems.
Order Management & Fulfillment
Process and validate customer purchase orders, ensuring compliance with pricing, contract terms, and company policies.
Partner closely with the 3PL provider to monitor order processing, inventory, shipping accuracy, and issue resolution. Coordinate backorders, allocations, and recall activities with Supply Chain and Quality.
Maintain audit-ready documentation in compliance with FDA, DEA, DSCSA, and PDMA regulations.
Business Analysis & Reporting
Develop and maintain operational and performance dashboards for customer service metrics (orders processed, fill rates, service levels, returns, and backorders).
Analyze sales order patterns, customer data, and inventory trends to identify opportunities for efficiency and improvements in customer experience.
Provide business insights to Sales, Supply Chain, and Finance through data visualization tools (Power BI, Tableau, Excel).
Process, Data & Systems
Partner with IT and process owners to improve ERP workflows, reduce manual work, and make reporting more reliable.
Help keep customer, product, and pricing data accurate across systems so orders, invoices and reports are correct.
Support continuous improvement initiatives that enhance accuracy, turnaround time, and compliance.
Skills
Strong analytical and problem-solving abilities with proficiency in data analysis, reporting, and visualization.
Excellent written and verbal communication skills.
Exceptional attention to detail and organizational skills.
Strong working knowledge of Microsoft Office Suite (Excel, Outlook, Word, PowerPoint).
Ability to manage multiple priorities in a fast-paced, regulated environment.
Customer-first mindset with an analytical and process-oriented approach.
Ability to translate data insights into operational improvements.
Collaborative team player who builds strong cross-functional relationships.
Requirements
Bachelor's degree in Business, Supply Chain Management, Data Analytics, or related field.
Minimum of 4-6 years of combined experience in customer service, sales operations, or business analysis within the pharmaceutical, biotech, or healthcare industry.
Experience with ERP systems (SAP, Oracle, JD Edwards, or similar) and data visualization/reporting tools (Power BI, Tableau, or Excel).
Prior experience collaborating with third-party logistics (3PL) providers strongly preferred.
Familiarity with pharmaceutical distribution and compliance regulations (FDA, DEA, DSCSA, PDMA) required.
The base salary range for this position is $85,000 - $105,000; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge.
ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company.
$85k-105k yearly Auto-Apply 26d ago
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Medical Science Liaison - Retina/ Ophthalmology
ANI Pharmaceuticals 4.4
Remote ANI Pharmaceuticals job
About Us
Welcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products.
With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike. We understand the importance of accessibility, and our products are available across a wide range of therapeutic areas, contributing to the well-being of communities globally.
Job Summary
The Medical Science Liaison will serve as a liaison to the medical/scientific community and will be responsible for establishing, developing, and maintaining relationships with medical experts in the Retina and/ or Ophthalmology Division nationwide.
Position Responsibilities
Ensure the appropriate dissemination of clinical and scientific information regarding marketed and pipeline compounds in a timely, ethical, and customer-focused manner
Implement clinical and educational strategies in collaboration with other ANI colleagues for designated customers that include potential clinical trial site placement and sponsorships
Work to pair our key scientific leaders educational and research needs with available ANI resources and will provide the latest emerging data in response to specific healthcare professional inquiries
Present healthcare professionals and decision makers with accurate, unbiased, balanced, and timely answers to unsolicited requests for information about ANI products
Establish scientific and clinical relationships with key opinion leaders and academic centers to expand research and educational opportunities for ANI products
Provide study support from protocol and budget development to submission and completion for Phase IV as well as Investigator Initiated Trials (IIT's)
Document and forward reports of adverse events to appropriate ANI personnel
Keep abreast of medical and scientific developments in assigned therapeutic area
Proactively report competitive activities as well as events that can influence the use of ANI products
Develop and deliver very specialized scientific/educational programs including but not limited to formulary presentations for managed care and related organizations
Assist Medical and Scientific Affairs as well as agency personnel in the development of presentations and slide kits
Actively participate in advisory boards, speaker training events, clinical investigator meetings, regional national and international meetings when required
Assist in processing of field request for medical education funding
Actively participate in key medical and scientific conferences by staffing medical information booths; gathering competitive intelligence on competitors and attending scientific sessions
Represents the organization as a prime field medical contact
Skills / Competencies
Excellent presentation skills as well as the ability to successfully interact with medical professionals at all levels
Working knowledge of FDA and OIG requirements as well as clinical trial design and statistics is required
Strong clinical knowledge including pharmacotherapy, treatment guidelines, clinical research processes, medical expert engagement strategies, and FDA promotional guidelines, regulations, and ethical guidelines applied to the pharmaceutical industry is preferred
Strong interpersonal communication and presentation skills are required
Ability to establish trust through the consistent demonstration of scientific expertise and satisfactory follow-through on requests from key experts in the scientific community
Strong communication skills; must be able to provide succinct, strategic, and actionable insights to senior management
A proactive self-starter who can lead work and manage others independently, with the ability to see the next step and take action without prompting
Thorough understanding of the healthcare environment including all external stakeholders
Ability to work effectively in a fast paced, rapidly changing and expanding environment
Outstanding work ethic and integrity, including high ethical and scientific standards
Deals with scientific concepts and complexity with confidence
Ability to manage multiple priorities and manage time efficiently
Work is primarily independent in that it is performed without appreciable day-to-day direction. Completed work is reviewed from a relatively long-term perspective for desired results against objectives
Requirements
The qualified candidate will have an advanced degree in a health-sciences related field such as a PharmD, MD, PhD
2+ years prior Field Medical position within the pharmaceutical industry
Previous experience in Retina/ Ophthalmology strongly preferred
Willingness to travel 60 % or more of the time
Extensive travel is integral to the performance of this position
The base salary range for this position is $165,000 - $185,000 ; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge. In addition to base salary, this position is eligible for participation in a competitive short term incentive program based on performance and company results.
ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company.
#LI-REMOTE
$165k-185k yearly Auto-Apply 60d+ ago
Pharmacy Relationship Manager
America's Pharmacy Group, LLC 4.5
Remote or Carteret, NJ job
Whether you are working in a Pharmacy, a seasoned healthcare sales expert, or aspiring to break into the Medical Sales industry, Healthcare Marketing Group, LLC provides an excellent opportunity for you. As a Pharmacy Relationship Manager, you will help drive the growth of our company through building and retaining customer relationships. You can even change the way healthcare is delivered to Americans.
Our Pharmacy Savings Card works like GoodRx and SingleCare. With savings of up to 80% off prescriptions, we provide the highest discounts in the industry!
We are now seeking Pharmacy Relationship Managers in your area!*
What does a Pharmacy Relationship Manager do?
Educate Pharmacy Staff about how their customers can save up to 80% on prescriptions
Provide Savings Cards by engaging with medical offices and educating Office Staff about how their patients can save up to 80% on medications
Create, build, and retain relationships with Pharmacy Staff and Healthcare Providers
Requirements
What you need to qualify:
Pharmaceutical/medical sales experience is preferred but not required
Sales skills with a proven track record
Exceptional interpersonal skills (building strong relationships)
Excellent verbal and written communication skills
Ability to work independently to oversee accounts and increase revenue
Reliable transportation (this position is partially remote and you will be visiting medical professionals in your area)
*We are currently hiring Pharmacy Relationship Managers in the San Antonio metropolitan area. Please only apply to one city; your desired territories will be discussed during the interview.
Benefits
Training and compensation:
We include comprehensive training and ongoing coaching
Monthly Bonuses
Great Commission!
$90k-135k yearly est. 6d ago
Associate, DEA Compliance
Hikma Pharmaceuticals USA Inc. 4.9
Cherry Hill, NJ job
Job Title: Associate, DEA Compliance
Job Type: Full-time
About Us:
As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.
Description:
We continue to be committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Associate, DEA Compliance. In this role, you will be responsible for guiding and supporting all DEA regulated business activities involved in the pharmaceutical manufacturing, analysis, and distribution of controlled substances. These activities include procurement, recordkeeping, chain of custody, production, distribution, and destruction. This position should also have the ability represent the company by interfacing with government agencies.
Key Responsibilities:
Regular and predictable onsite attendance and punctuality.
Act as DEA Coordinator by monitoring and coordinating all DEA related actives at the Hikma Dayton, NJ facility.
Train with staff and onsite activities at the Hikma Cherry Hill, NJ facility as needed.
Work with Hikma Security to implement and maintain security control measures relating to the safekeeping of controlled substances.
Monitor controlled substance quotas.
Monitor chain of custody transfers throughout manufacturing and laboratory support operations.
Ensure clear and efficient methods for maintaining Production Batch Record accountability.
Report CSOS and ARCOS through the DEA website.
Conduct inventories for initial, year-end, change in Pharmacist In Charge.
Monitor and report the destruction of controlled substances.
Work with Hikma Quality, Environmental, Health & Safety, and Logistic Teams.
Review and develop policies and procedures relating to controlled substance compliance.
Maintain a state of inspection readiness throughout all Controlled Substance Compliance activities.
Qualifications:
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
Minimum: Bachelors' degree or equivalent with a minimum of 3 years' work experience or an equivalent overall level of knowledge based upon previous work experience.
Preferred Qualifications:
Experience in injectable manufacturing.
Compensation:
Base Salary: $56,950 to $95,000 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.
What We Offer*:
Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
3 personal days (prorated based on hire date)
11 company paid holidays
Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
Employee discount program
Wellbeing rewards program
Safety and Quality is a top organizational priority
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave
*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Recruiters:
Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.
Equal Opportunity Employer:
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
$57k-95k yearly 60d+ ago
Process Operator I - 3rd Shift
Hikma Pharmaceuticals 4.9
Cherry Hill, NJ job
Job Title: Process Operator I - 3rd Shift Job Type: Full-time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.
Description:
We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Process Operator I. In this role, you will be responsible for setting up, adjusting, maintaining and operating various pieces of equipment i.e. automatic glass washers, depyrogenation tunnels, cappers, tray loaders, and automatic bag openers. The Process Operator I is responsible for complying with all cGMPs, SOPs, equipment parameters and safety regulations. This job has no supervisory responsibilities. However, training of others is a requirement.
Key Responsibilities:
* Prepares equipment at start of lot.
* Verifies incoming components for correctness using Order Number.
* Set up and operates equipment throughout shift.
* Monitors parameters i.e., machine speed, water pressure, temperature, belt speed, etc. periodically during the shift and records as required per SOPs and cGMPs.
* Clean and clears equipment and work area at the beginning and end of each production run.
* Maintains quality of machine output; including, but not limited to:
* Reporting manufacturing/component deviations; including, but not limited to, visually defective glassware or components to the area Process Supervisor or designee.
* Reporting process deviations to area Process Supervisor or designee.
* Completes all required batch record and logbook paperwork.
* Trains individuals on equipment, when required.
* Maintains general housekeeping of equipment and area throughout shift.
* Works overtime as required to support business needs.
* Performs all other duties as assigned by management personnel.
Qualifications:
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
* Education: High School Diploma or Equivalent
Language Skills:
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to complete required documentation.
Mathematical Skills:
Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and/or decimals.
Reasoning Ability:
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
Physical Demands:
On feet 100% of the time while performing the duties of this job. Requires lifting 5-40 lbs continuously throughout the workday. Requires frequent bending, twisting, pushing, pulling and lifting.
Work Environment:
Noise level in the work environment is usually moderate to loud. Hearing protection may be required in some areas. The atmosphere in some work areas at times will be warm and humid.
Compensation:
Hourly Rate: $20.00 per hour. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.
What We Offer*:
* Annual performance bonus, commission, and share potential
* Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
* A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
* 3 personal days (prorated based on hire date)
* 11 company paid holidays
* Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
* Employee discount program
* Wellbeing rewards program
* Safety and Quality is a top organizational priority
* Career advancement and growth opportunities
* Tuition reimbursement
* Paid maternity and parental leave
* Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Recruiters:
Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma
Equal Opportunity Employer:
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
Location:
Cherry Hill, NJ, US, 08003
Nearest Major Market: Philadelphia
$20 hourly Auto-Apply 26d ago
Clean Room Operator - 3rd Shift
Hikma Pharmaceuticals 4.9
Cherry Hill, NJ job
Job Title: Clean Room Operator - 3rd Shift - Sunday 7:00am - 3:30pm, Monday-Thursday 9:30pm - 6:00am Job Type: Full-time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.
Description:
We continue to be committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Clean Room Operator. In this role, you will be responsible for cleaning and disinfecting all aseptic and controlled production areas prior to each day's scheduled operation under cGMP's, SOP/Job Aids and Safety requirements.
Key Responsibilities:
* Cleans/disinfects clean room walls, ceilings, windows, ledges, vents, light fixtures, hoods and floors throughout all aseptic cores and ancillary rooms on a daily basis.
* Disposes trash generated within work areas and places clean trash cans in their original locations.
* Must successfully complete gown qualification program and must maintain gown qualification.
* Uses all department equipment, including but not limited to vacuums, sprayers and foggers in a safe and efficient manner.
* Understands and complies with aseptic training guidelines.
* Reports all safety and maintenance concerns to immediate supervisor.
* Signs all necessary production records.
* Works overtime as required to support business needs.
* Performs other duties as determined by management personnel.
Qualifications:
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
* High School diploma or equivalent. Prior production experience preferred.
Language Skills:
* Ability to read and interpret written documents such as safety rules, operating and maintenance instructions and procedure manuals.
* Ability to complete required documentation such as production batch records.
* Ability to communicate orally and in writing.
Mathematical Skills:
* Ability to add, subtract, multiply and divide in all units of measure using whole numbers, common fractions and/or decimals.
Reasoning Ability:
* Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form.
* Ability to deal with problems in accordance with approved procedures.
Physical Demands:
* On feet 80% of the time applying cleaning solutions and sanitizing agents on ceilings, walls and floors. Requires pushing or lifting 30-40 lbs over 50% of the time. Requires frequent bending, twisting, pushing, pulling and lifting.
Work Environment:
* Must be gown qualified to work in a clean room environment. Production areas are usually wet.
Hazards:
* Exposure to wet floors, strong chemicals and hot WFI. May incur minor cuts, abrasions, bruises, slight burns or muscle strains.
Compensation:
Hourly Rate: $20.00 per hour. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.
What We Offer*:
* Annual performance bonus, commission, and share potential
* Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
* A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
* 3 personal days (prorated based on hire date)
* 11 company paid holidays
* Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
* Employee discount program
* Wellbeing rewards program
* Safety and Quality is a top organizational priority
* Career advancement and growth opportunities
* Tuition reimbursement
* Paid maternity and parental leave
* Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Recruiters:
Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.
Equal Opportunity Employer:
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
Location:
Cherry Hill, NJ, US, 08003
Nearest Major Market: Philadelphia
$20 hourly Auto-Apply 4d ago
Executive Administrative Assistant
ANI Pharmaceuticals 4.4
ANI Pharmaceuticals job in Princeton, NJ
The Executive Administrative Assistant will be part of a fast-paced, growing organization in our Princeton, NJ office. The incumbent will provide personalized and timely support in daily calendar planning, setting up meetings, and travel arrangements for the Head of Rare Disease and key leaders within the Rare Disease leadership team. This role requires someone who can manage multiple tasks, is a quick learner, has agility to respond to new or changing requests, and who has strong people orientation and collaboration skills.
Responsibilities
Provides daily administrative support and assistance, onsite and virtually to the assigned leaders. Tasks may include calendar planning, setting up meetings, arranging travel, preparing expense reports, capturing and distributing agendas, preparing documents and letters, etc.
Performs other office tasks such as maintaining office records, ordering supplies, filing, and receiving/sending out mail.
When required, attends meetings to take notes/record minutes and send out summary of key actions to participants.
Provides timely administrative support to write emails, format documents, prepare presentations, reports, etc. for assigned leaders.
Acts as a point of contact for leaders and prioritizes incoming requests for leaders' time, setting up meetings accordingly.
Screens and directs phone calls and distributes office correspondence as required.
Serves as the backup to the CEO EA
Performs other duties as assigned or requested.
Requirements:
Excellent verbal and written communication skills with internal and external customers, leveraging strong interpersonal skills
Able to effectively interact with all levels of management, associates, and the board
Strong organizational skills and attention to detail
Excellent time management skills with a proven ability to meet deadlines
Agile and able to function well in a high-paced and at times stressful environment, managing multiple projects and sometimes competing priorities
Strong problem-solving abilities and ability to work through challenges to deliver results
Collaborative and people-oriented; has a customer service orientation
High integrity, discretion, and confidentiality
Able to work independently with minimal supervision; proactive and self-directed
Strong MS Office skills in Word, PowerPoint, and Excel as well as Concur and ADP Workplace preferred. Ability to learn new or updated software
Extensive knowledge of office administration and clerical procedures
Strong planning and organizational skills
Able to type minimum of 50 words per minute
5+ years of experience as an administrative assistant, supporting executive-level clients
1-3 years of experience as an office manager preferred
Experience working in a fast-paced environment, adapting to changing needs and supporting multiple partners
Experience working in a healthcare or pharmaceutical organization is preferred
High school diploma required; Bachelor's degree in Business Administration or related field preferred
TRAVEL
Very occasional travel may be required, with advance notice
Role is located at our Princeton office
WORKING CONDITIONS
Office environment, with prolonged periods sitting/standing at a desk and working on a computer
Must be able to lift up to 15 pounds at times
Must be able to be on site in our Princeton, NJ office 3-5 days per week
The base salary range for this position is $100,000 - $130,000 ; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge.
ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company.
$41k-61k yearly est. Auto-Apply 19d ago
Manager, Quality Assurance
Hikma Pharmaceuticals 4.9
Dayton, NJ job
Job Title: Manager, Quality Assurance Job Type: Full-Time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.
Description:
We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Quality Assurance Manager to join our team. In this role, you will be responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that products are manufactured in compliance with cGMP guidelines, USP and FDA, EU requirements. In addition, you will be responsible to direct batch record review, control and release, handle investigation process (CAPA) assuring that any discrepancies are investigated thoroughly and in a timely manner.
Key Responsibilities:
* Regular and predictable onsite attendance and punctuality.
* Directs the batch record review process. Makes final accept/reject disposition on product lots. Assures batch is manufactured in compliance with NDA/ANDA/EU, cGMP and Validation parameters. Ensures that records are reviewed and released in a timely manner.
* Coordinates communication for status of lots and status of and resolves issues related to accept/reject disposition of batches.
* Places lots on HOLD if Quality issues are detected and notifies senior management.
* Coordinates destruction of rejected finished goods and assures destruction occurs in a timely manner.
* Expedites and prioritizes product releases by coordinating the Review, testing, and releases with site management to meet customer service requirements.
* Conducts routine investigation and departmental meetings to facilitate the performance of release function.
* Manages personnel for in-process filling and inspection/packaging monitoring
* Provide QA oversight of Operation for the entire Manufacturing process, supporting Clean room technicians and production technicians as needed to identify and address product quality compliance issues as they arise.
* Provide training and assistance to all Clean room and operation personnel for NCR, CAPA and Change Control.
* Provides QA review and approval of manufacturing investigations assuring timely review, follow-up, tracking and trending of MIRs. Perform Root Cause analysis and assure corrective action (CAPA) implementation associated with manufacturing investigations. Provide guidance to the investigation scientists on reporting and metrics required for different levels within organization.
* Performs QA review and approval of LIR's (Laboratory Investigation Reports).
* Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents.
* Establish a qualification and Requalification program for Clean Room Certification and Recertification, for ISO 5 and 7 environments.
* Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff.
* Assists the QA management in developing on department budget.
* Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions.
* Manages attendance records for all direct reports.
Qualifications:
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
* Minimum: Bachelor's degree in Pharmacy, Biology, Chemistry or a related field
* Preferred are beneficial [List the required qualifications such as education, skills, and experience]
Preferred Qualifications:
* Additional college courses in Microbiology, cGMPs, Statistics or Quality Management
Skills:
* Must have history of strong documentation skills and attention to detail
* Familiarity with cGMPs and CFR for US and EU
* Excellent organizational skills and ability to multi-task and perform work in a timely manner
* Demonstrates ability to lead a department, projects and meetings effectively
* Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management
* General computer skills and ability to prepare presentations and address large groups
* Demonstrated attention to details and accuracy
* The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must
Compensation:
Base Salary: $92,850 to $158,450 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.
What We Offer*:
* Annual performance bonus, commission, and share potential
* Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
* A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
* 3 personal days (prorated based on hire date)
* 11 company paid holidays
* Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
* Employee discount program
* Wellbeing rewards program
* Safety and Quality is a top organizational priority
* Career advancement and growth opportunities
* Tuition reimbursement
* Paid maternity and parental leave
* Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Recruiters:
Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.
Equal Opportunity Employer:
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
Location:
Dayton, NJ, US, 08810
Nearest Major Market: New Jersey
$92.9k-158.5k yearly Auto-Apply 44d ago
Technician, Metrology Calibration - 3rd Shift
Hikma Pharmaceuticals 4.9
Cherry Hill, NJ job
Job Title: Technician, Metrology Calibration - 3rd Shift Job Type: Full-time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.
Description:
We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Technician, Metrology Calibration. In this role, you will be responsible for the precise science of measurement. They have a wide range of responsibilities within a laboratory environment; most importantly, they apply their knowledge of measurement science and mathematics to properly calibrate all inspection, measurement, and test (IM&T) equipment to ensure that such equipment meets all requirements for accuracy and precision. Other responsibilities performed by a metrology calibration technician include collecting, analyzing, and summarizing any data obtained from the calibration process, as well as accurately preparing calibration reports, adapting calibration equipment for new or unusual measurement tasks, and correcting any measurement errors as soon as they have been identified.
Key Responsibilities:
* Compare readings of measuring devices to established standards and adjust them to achieve proper output.
* Maintain, troubleshoot, and repair production instruments when necessary.
* Manage and maintain the documentation of all calibrations and investigations for potential calibrations.
* Assist in maintaining the production instrumentation and conduct calibrations on all production equipment. e.g. (Temperature, Pressure & Humidity Transmitters, Autoclaves, Ovens, Conductivity, Balances, Load Cells etc.).
* Research and make recommendations for new equipment or parts.
* Training colleagues in calibration procedures and maintaining the cleanliness and general upkeep of the production equipment instrumentation.
* Advising non-related departments on technical matters.
* Able to lift and maneuver 25 kg weights.
* Regular and predictable onsite attendance and punctuality.
Qualifications:
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
* Minimum: High School diploma or equivalent
* Must have knowledge of algebra to solve measurement-related issues and decide how to address measurement errors
* Knowledge of basic electronics and basic computer skills (Word and Excel) are essential in this occupation
Preferred Qualifications:
* Technical school preferred
* 1 year of instrumentation experience preferred
What We Offer*:
* Annual performance bonus, commission, and share potential
* Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
* A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
* 3 personal days (prorated based on hire date)
* 11 company paid holidays
* Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
* Employee discount program
* Wellbeing rewards program
* Safety and Quality is a top organizational priority
* Career advancement and growth opportunities
* Tuition reimbursement
* Paid maternity and parental leave
* Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Recruiters:
Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.
Equal Opportunity Employer:
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
Location:
Cherry Hill, NJ, US, 08003
Nearest Major Market: Philadelphia
$61k-95k yearly est. Auto-Apply 3d ago
Summer Internship - Data Analytics
Hikma Pharmaceuticals 4.9
Berkeley Heights, NJ job
Job Title: Intern - Data Analytics Job Type: Intern Compensation: $19.00/hour About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.
Description:
We are seeking a motivated and detail-oriented Data Analytics Intern to join our Advanced Analytics team. This internship offers a unique opportunity for hands-on experience in analytics projects with real-world impact. This role is ideal for students passionate about data, analytics, and technology who want to apply their knowledge to impactful business problems. This person will work closely with experienced professionals, gain practical analytics experience with leaders who know how to translate data into business decisions.
Internship will commence in May and end no later than August.
Responsibilities:
* Assist in designing and executing data analytics projects aligned with business needs
* Consolidate and transform customer forecast files into a unified database, starting with Excel and progressing toward automated solutions
* Investigate SAP data structures and relationships to support SQL-based data modeling for the enterprise data lake
* Develop and test Power BI prototypes to simulate data lake models and visualize key metrics
* Support proof-of-concept AI initiatives as needed
* Document processes, data flows, and findings to ensure clarity and reproducibility
* Collaborate with team members to troubleshoot issues and refine solutions
* Communicate insights and progress effectively to business stakeholders
* Other activities as assigned
Qualifications:
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
* Completed one year of college course work toward a degree in Business Analytics, Data Science, Computer Science, including at least 12 credit hours of related coursework.
* Must be an Undergraduate, Graduate, or Professional Student in good academic standing.
* Proficiency with some of the following analytical disciplines
* Data Manipulation and Analysis (Excel, SQL, Python)
* Business Intelligence Tools (PowerBI, Tableau, Celonis)
* Predictive Modeling and Machine Learning Concepts
* Database Design, Database Structure and Data Modeling
* Desired competencies include strong communication skills, taking initiative, problem solving skills, being detail oriented, and good teamwork.
* Highly motivated and inquisitive with a strong desire to learn.
* Proficient usage of Microsoft Office applications.
* Regular and predictable onsite attendance and punctuality.
* Must be legally authorized to work in the United States without restriction, no sponsorship offered at this time.
* Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background.
* Must be willing to take a drug test.
* Must be 18 years of age or older.
This internship provides an excellent platform for aspiring analyst to develop their skills while contributing to exciting projects within our organization.
Recruiters:
Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.
Equal Opportunity Employer:
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
#LI-KJ1
Location:
Berkeley Heights, NJ, US, 07922 Columbus, OH, US, 43228
Nearest Major Market: New Jersey
$19 hourly Auto-Apply 3d ago
Compounding Pharmacist
Hikma Pharmaceuticals 4.9
Cherry Hill, NJ job
Job Title: Compounding Pharmacist Job Type: Full-time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.
Description:
We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and Compounding Pharmacist will support the Associate Director of Operations and is responsible for supervising production operations of Compounded Sterile Preparations by implementing and maintaining Sterile Compounding policies/strategies in alignment with all regulatory authorities/guidance's and Hikma Corporate plans and policies. The Compounding Pharmacist will also evaluate any possible significant trends across the site and help drive continuous improvement efforts to adhere to regulatory requirements.
Key Responsibilities:
* Ensure adherence to batch records and aseptic techniques.
* Monitor Compounding personnel for compliance with gowning, behavior and aseptic technique.
* Conduct Investigations for manufacturing deviations.
* Execute CAPAs & Change Controls.
* Provide Aseptic Training
* Provide oversight of compounding and production activities, ensuring compliance with the FDA CFR, including cGMP and DEA regulations, as well as State Board of Pharmacy rules and regulations.
* Keep abreast of relevant guidance documents pertaining to 503B production.
* Monitor and communicate changes in regulations of all state and federal regulatory agencies.
* Assist in new 503B product development, including collaborating on labeling, stability study protocols, Master Batch Records, and product specification requirements ensuring compliance with all company procedures and federal and state laws, rules, and regulations.
* Attain all non-resident Pharmacist licenses within 1 year.
* Assist the Associate Director of Compounding Operations in daily oversight of compounding personnel and compounding operations in cleanroom environments.
* Review, prepare and approve manufacturing deviations, master batch records and site change controls related to 503B Compounding Operations.
* Participate in the administration of Site Projects and New Product Launches to support 503B operations.
* Assist in the development and provision of GMP, Aseptic Behavior, and Quality Systems-related training to all applicable departments.
* Provide technical support in the interactions with and applications to state and federal regulatory bodies.
* Provide assistance in collection of documents and records regarding state licensing and renewals for state boards of pharmacy.
* Assist in writing, review and update of batch records, SOPs, and other cGMP documents.
* Maintain current pharmacist licenses in required states, as directed.
* Other duties as assigned.
Qualifications:
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
* Bachelor of Pharmacy or PharmD required.
* State of New Jersey license as a pharmacist is required. Multiple state licenses preferred or ability to obtain state license for the following (AL, AR, ID, KS, MI, MS, NV, NY, OH, OK, KY, VA).
* 503B Compounding experience and/or USP 797 knowledge and experience required.
* Knowledge of sterile compounding practices.
* Knowledge of associated standards and operating procedures in relation to cGMP.
* Knowledge of 503B practices, aseptic processes (gowning, garbing, gloving etc.)
* A broad perspective to organize objectives, both long-term and day-to-day activities
Experience and Skills :
* Pharmacist for a 503B outsourcing facility located in New Jersey preferred
* New Jersey licensure is required, as well as the ability to obtain multiple state licenses.
* Previous experience with 503B outsourcing, USP 797, and/or hospital IV compounding would be an advantage.
* The ability to change direction and focus to meet shifting organizational and business demands.
* The ability to create and contribute to an environment that values people encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
* The ability to effectively manage self, demonstrate integrity, be productive under pressure, and achieve development goals.
* The ability to take strategic objectives and accept accountability, motivate and influence others, think globally, and leverage diversity.
* The ability to manage multiple resources and be accurate and current with data and information.
* Ability to communicate technical information to non-technical personnel
Compensation:
Base Salary: $ 66,600 to $ 133,750 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.
What We Offer*:
* Annual performance bonus, commission, and share potential
* Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
* A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
* 3 personal days (prorated based on hire date)
* 11 company paid holidays
* Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
* Employee discount program
* Wellbeing rewards program
* Safety and Quality is a top organizational priority
* Career advancement and growth opportunities
* Tuition reimbursement
* Paid maternity and parental leave
* Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Recruiters:
Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.
Equal Opportunity Employer:
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
Location:
Cherry Hill, NJ, US, 08003
Nearest Major Market: Philadelphia
$66.6k-133.8k yearly Auto-Apply 60d+ ago
Mechanic I, Facility - 1st Shift
Hikma Pharmaceuticals 4.9
Cherry Hill, NJ job
Job Title: Mechanic I, Facility Job Type: Full-time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.
Description:
We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Mechanic I, Facility. In this role, you will be responsible for performing preventative maintenance, routine maintenance and submitted work orders to keep the facility buildings in good operation. Escorts and oversees contractors hired to complete facilities repairs: roofs, floors, doors, walls, office changes and renovations to ensure contractors are compliance with pharmaceutical rules. Maintains shop area of tools and equipment, orders items needed for repairs and stock. Assist other maintenance personnel when required. Performs other duties as assigned by the maintenance supervisor or engineers not necessarily related to the general duties.
Key Responsibilities:
* Regular and predictable onsite attendance and punctuality.
* Spackle and caulk walls.
* Meet and discuss repair issues will all personnel.
* Escort of contractors and Pest control staff.
* Office furniture relocation and repairs.
* Investigating facility issues with use of ladders.
* Assist with housekeeping equipment installations.
* Masonry, patching walls and floors.
Qualifications:
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
* High school diploma or equivalent.
* Moderate physical exertion necessary as continual moving around the facility, lifting 30 to 40 lbs. may be required.
* Ability to climb ladders to investigate above ceilings.
* Routine and interpretive decision-making skills needed.
Preferred Qualifications:
* Trade school or carpentry skills a plus.
Compensation:
Hourly Rate: $25.00 per hour. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.
What We Offer*:
* Annual performance bonus, commission, and share potential
* Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
* A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
* 3 personal days (prorated based on hire date)
* 11 company paid holidays
* Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
* Employee discount program
* Wellbeing rewards program
* Safety and Quality is a top organizational priority
* Career advancement and growth opportunities
* Tuition reimbursement
* Paid maternity and parental leave
* Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Recruiters:
Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.
Equal Opportunity Employer:
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
Location:
Cherry Hill, NJ, US, 08003
Nearest Major Market: Philadelphia
$25 hourly Auto-Apply 34d ago
Legal Counsel
Tris Pharma 4.2
Monmouth Junction, NJ job
Tris Pharma, Inc. (******************* is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.
Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another. We believe in each other and in respectful, open and honest communications to help support individual and team success.
We have an immediate opening at our Monmouth Junction, NJ offices for a Legal Counsel to join our small in-house Legal team.
This role plays a crucial role in providing comprehensive legal guidance across business departments/functions and various aspects of business operations. Reporting directly to the Senior Vice President (SVP)/General Counsel Chief Compliance Officer (CCO), the incumbent serves as a cross-functional subject matter expert (SME), supporting Senior Leadership in strategic and risk aware decision-making, as well as ensuring compliance with regulatory requirements and company Standard Operating Procedures (SOPs), as appropriate.
ESSENTIAL FUNCTIONS
Primary duties/responsibilities
Reviews, negotiates and drafts a diverse array of commercial contracts (i.e., licensing, co-development, manufacturing and supply, distribution agreements, clinical trial, partnership agreements, etc.); Collaborates closely with internal stakeholders to gather specifications and key business terms necessary for effective contract negotiations
Provides strategic legal advice on a wide range of legal issues, analyzing legal risks associated with business transactions, clinical research activities and product commercialization; Offers guidance on matters subject to disputes and ensures alignment with corporate objectives
Supports contract management by developing and maintaining contract templates to streamline contracting process, enhancing efficiency and consistency in contract administration; Successfully collaborates with external customers and internal clients regarding contract development, negotiations and disputes
Supports regulatory submissions and communications with various regulatory authorities (i.e., FDA), new product launches, pricing/rebate analysis, drug price reporting, reimbursement activities and commercial/research publications (i.e., healthcare economic material, etc.)
Stays current on laws and regulations impacting the pharmaceutical and healthcare industries, advises on legal rights under contracts, compliance requirements and regulatory submissions, as needed; Collaborates with internal stakeholders to ensure adherence to local, state and federal laws and regulations
Develops and administers training programs to internal clients on transactional and regulatory matters and industry best practices empowering stakeholders with knowledge and skills necessary to effectively navigate legal issues
Collaborates with internal departments including, but not limited to: Commercial, Finance, Human Resources (HR), Regulatory Affairs and Compliance, to provide legal guidance and support on laws, regulations, standard operating procedures and company policies affecting business; Works closely with outside counsel, as needed
Proactively assesses legal risks and provides guidance to executive leadership and business teams, contributing to informed decision-making and mitigating potential liabilities; Independently creates legal documents for departmental and internal client use
Requirements
Minimum education and years of relevant work experience
Juris Doctor (JD) degree from accredited law school, including bar admission within one or more U.S. state(s) and minimum 5 years legal experience in the pharmaceutical, biotechnology or related industry in positions of increasing strategic and leadership responsibility REQUIRED
Excellent understanding and experience working with transactions, laws and regulations associated with development, manufacture, marketing and sale of pharmaceutical products REQUIRED
Current, hands-on experience drafting, reviewing, negotiating, and executing a wide variety of transactional and legal documents (i.e., master services agreements, confidentiality agreements, drug distribution, supply, commercial agreements, market access, clinical trials, pricing and reimbursement, etc.) REQUIRED
Strong working knowledge of, and/or direct exposure to, pharmaceutical business functions such as Compliance, Regulatory Affairs, Government Affairs, Commercial Operations, HR and Finance REQUIRED
Ability to influence without direct authority REQUIRED
Work Arrangements: We are a HYBRID work environment requiring local candidates to be able to work majority of week in our NJ office. Non-local candidates must be able to come into office multiple times a month.
Anticipated salary range: $155 to $185K/yr. Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity.
Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.
Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-hybrid
$155k-185k yearly 2d ago
Packaging Technician Lead
Tris Pharma 4.2
Monmouth Junction, NJ job
Tris Pharma, Inc. (******************* is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.
Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris' passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company's success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other and we believe in respectful, open and honest communications to help support individual and team success.
This position is temporary to potential hire opportunity, based on company needs and successful performance.
Located in Monmouth Junction, NJ, Tris has immediate openings for (2) Packaging Technician Leads for 2nd SHIFT.
Shift is 4 days/week for 10 hrs. Mon-Thurs, Hours are 3:00 pm - 1:00 am
The Packaging Technician Lead is responsible for supporting and assisting in the packaging of a range of pharmaceutical products in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications. She/he operates, sets-up, and maintains various pharmaceutical packaging equipment as assigned, and thoroughly and accurately documents all activities to ensure compliance with regulatory guidelines.
The incumbent collaborates closely with the Supervisor, Packaging and may be asked to perform many senior and supervisory packaging functions/initiatives in the supervisor's absence including, but not limited to coordination of daily packaging activities and supervision of safety and workflow, etc.
ESSENTIAL FUNCTIONS
Primary duties/responsibilities
· Supports and assists in the packaging of pharmaceutical products according to SOPs, cGMPs, FDA standards and batch record specifications
· Performs the day to day activities of the packaging process as assigned; Operates various types of Packaging equipment including, but not limited to: fillers, cappers, labelers, cartoners, bundlers, shrink wrappers, etc. to ensure efficient packaging of goods
· Assists in set up, change over and test runs of equipment for various sized batches and various products, as needed
· Collaborates with other production staff and departments
· Accurately and consistently completes and documents batch records and other required paperwork
· Precisely follows work orders and specifications
· Adheres to all plant safety policies and procedures
· Assists with organization of daily schedule and assigns personnel to the various workspaces to meet the demand of planning
· Reports and investigates any deviations from processes or procedures
· Maintains a presence on the packaging floor at all times, Trains new employees and mentors lower-level technicians, as appropriate
· May assist with the development and writing of SOPs and investigation reports and contributes to the circulation of the documents under approved procedures
· Assists in maintaining a safe and clean work environment by educating and directing personnel on the use of all control points, equipment, and resources, maintaining compliance with established policies and procedures
Works extra hours or weekends as required by management to meet the demands of the schedule
Requirements
REQUIREMENTS
· High school diploma or equivalent REQUIRED
· Ability and willingness to learn manufacturing procedures and federal regulations pertaining to manufacturing processes REQUIRED
· Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc. REQUIRED
· Strong record keeping skills/ability REQUIRED
· Excellent verbal and written communication and skills REQUIRED
Minimum education and years of relevant work experience
· High school diploma or equivalent AND minimum 5 years experience working in a pharmaceutical or biotechnology cGMP regulated environment.
S
pecial knowledge or skills needed and/or licenses or certificates required
· Working knowledge of manufacturing procedures and federal regulations pertaining to manufacturing processes
· Working knowledge of good manufacturing systems and familiarity with regulatory and manufacturing SOPs and cGMPs
· Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc.
· Proficiency with Microsoft Office
· Excellent verbal and written communication and skills
· Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
· Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
· Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
· Fluent in English (verbal and written)
· Ability and willingness to work additional hours as required by business needs
Special knowledge or skills needed and/or licenses or certificates preferred
Solid dose manufacturing experience
Associates degree or some college coursework
Travel requirements
0%
Physical requirements
Manufacturing based position
Ability to lift up to 50 lbs
Ability to use Personal Protective Equipment (PPE)
Ability to stand for extended periods
Anticipated pay rate: $23-28/hour. There is an additional $1.50 per hour for the shift differential.
Pay rate offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity.
Additional benefits: In addition to base salary, full-time employees (does not pertain to temporary employees), are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.
Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.
$23-28 hourly 11d ago
Supervisor, Microbiology
Hikma Pharmaceuticals USA Inc. 4.9
Cherry Hill, NJ job
Job Title: Supervisor, Microbiology
Job Type: Full-time
About Us:
As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.
Description:
We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Supervisor, Microbiology. In this role, you will be responsible for the supervision of microbiologists performing pharmaceutical microbiological procedures and the accuracy of test results and raw data generated. The qualified candidate must possess a strong background in sterility testing using isolator technology, sterility testing validation, Biological Indicator studies, water system sampling and testing, bioburden testing, Bacterial Endotoxin Testing (BET), bioburden and BET validation testing, microbial identifications, disinfectant studies, Antimicrobial Effectiveness Testing (AET) and AET validation, growth promotion testing of media/diluents, preparation of cryopreserved microbial cultures, and media/diluent preparation. The qualified candidate must have experience interacting with the FDA and other regulatory/audit groups. This position will be responsible for resolving technical/equipment problems, implementing corrective/preventive actions, writing/ revising standard operating procedures, forms, protocols, test methods and change controls, and providing guidance to less senior staff.
Key Responsibilities:
Control the workflow of the microbiology laboratory by supervising, planning, organizing, and directing the activities of the group to support production, stability program, technical services, and R&D. Ensure adequate supplies and equipment are available for testing and maintain expenses at or below budget. Analyze workflow, prepare metrics, and make recommendations to improve productivity and efficiency of group and generate cost savings.
Enforce policies and procedures by monitoring the testing techniques and accuracy of all records and documentation that is done in the lab to ensure compliance. Ensure that team members are properly trained and proficient before allowing them to perform any tasks. Review laboratory records for accuracy, completeness, compliance, and conformance to specifications. Approve laboratory records and ensure initiation of laboratory events and investigations as required. Ensure compliance in the group and keep the department ready for both internal and external audits.
Oversee instrument/equipment maintenance and calibration programs. Troubleshoot and resolve instrument/equipment problems. Ensure maintenance and calibrations are done in accordance with required schedule. Develop proposals for new laboratory systems and equipment. Execute validation studies, prepare summary reports, and change controls. Stay current on laboratory instruments and methods. Ensure completion of all protocols, validations, and summary reports in a timely manner.
Prepare and/or revise SOPs to ensure compliance with regulations and current practices. Keep current on regulations and industry best practices pertaining to the group and update SOPs to improve compliance. Prepare and execute change controls as needed to support changes to the program.
Make appropriate staffing recommendations, support laboratory cross-training efforts, evaluate team member performance, perform appraisals, and ensure team members have development plans.
Resolve deviations. Investigate and/or work closely with investigators to determine root cause of deviations. Prepare all necessary reports in a timely manner to meet compliance requirements and business needs.
Interact with FDA and other regulatory/audit groups. Working knowledge of FDA regulations and application of GLPs and GMPs
Qualifications:
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
Must have a BS and 7 years of pharmaceutical microbiology experience or a MS and 5 years of pharmaceutical microbiology experience. Must have 3-5 years of supervisory experience.
Excellent organizational and project management skills and ability to handle multiple projects.
Excellent writing and computer skills and ability to present data in a logical manner.
Excellent interpersonal, communication, influencing, negotiation skills.
Understanding of scientific strategies and ability to invent new methods or new avenues of investigation.
Demonstrated effectiveness in task completion, decision making, and problem solving.
Working knowledge of FDA regulations, application of GLPs and GMPs. Experience interacting with personnel from regulatory agencies
Preferred Qualifications:
Pharmaceutical Microbiology experience with injectable/aseptic manufacturing preferred.
Compensation:
Base Salary: $66,600 to $133,0750 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.
What We Offer*:
Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
3 personal days (prorated based on hire date)
11 company paid holidays
Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
Employee discount program
Wellbeing rewards program
Safety and Quality is a top organizational priority
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave
*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Recruiters:
Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.
Equal Opportunity Employer:
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
$66.6k-133.1k yearly 60d+ ago
Ophthalmology Account Executive Manhattan/Bronx
ANI Pharmaceuticals 4.4
ANI Pharmaceuticals job in Princeton, NJ
This role will report into the Commercial - Rare Disease Team, Ophthalmology Division at ANI and will cover the following locations: Manhattan/Bronx. This is an exciting opportunity to be part of an expanded new presence in the ophthalmology and eye-care space. The position requires performance driven individuals with strategic problem-solving skills and high business acumen that can work collaboratively with multiple stakeholders. The ideal candidate will have sales experience in rare disease and in Retina/Ophthalmology. Experience launching a drug in a competitive space with a track record of market growth is desired.
Reporting to the ANI Rare Disease Area Business Director - Ophthalmology, the Ophthalmology Account Executive (OAE) will drive physician and patient identification, market development, and disease/ brand awareness within the assigned territory. A successful OAE will maintain a high level of knowledge within targeted disease states, product labeling, and achieve territory sales targets and other business objectives through account and customer-specific strategies.
Activities include disease state education to referring HCPs, office readiness for a patient starting therapy, as well as coordination of multiple departments/stakeholders and ANI's Rare Disease field-based reimbursement and medical support teams. Skills required include account management, organizational, analytical, and problem-solving. Individuals must be flexible and adaptable with sensitivity to the potential constraints of a commercial start-up. Candidates will be goal-oriented and accountable for their individual performance while acting in a professional and compliant manner.
Responsibilities
Driving demand through clinical selling and education to referring and treating health care providers on Cortrophin Gel and ILUIVEN.
Build and execute territory strategy and account-specific plans to drive physician and patient identification, market development, and brand awareness in Ophthalmology and Retina, as well as continuously assess sales opportunities within markets and accounts to maintain and grow the business.
Prioritize and manage resources, activities, and time to optimize access to and development of accounts with the most sales potential.
Build individual account plans for key accounts and physicians, including how to approach those customers, and how to maximize sales results.
Build and maintain relationships with physicians by maximizing their time through pre-call planning, leveraging insights to customize a call plan, and conduct post-call analysis to continually refine and enhance their approach.
Collaboration with members of Ophthalmology brand team, and facilitating appropriate collaboration with other functions, such as MSLs, Market Access team, patient HUB and other internal stakeholders, to help ensure access and that logistics are in place to ensure patients can benefit from Cortrophin Gel and ILUVIEN.
Partner externally with key accounts and physicians to drive patient identification through market development and physician education; develop a territory strategy to retain customers.
Demonstrate the highest standards of integrity and compliance.
Other duties as assigned.
Requirements
Bachelor's degree required; Advanced degree in business or science preferred.
5+ years of demonstrated success in rare disease, retina and/or specialty pharmaceutical sales.
Extensive experience calling on Retina Specialists, Ophthalmologists and Eye Care Professionals is strongly preferred.
Sales experience within multiple ophthalmology sub-specialty areas is ideal/preferred
Product launch experience is a plus, including a working knowledge of government and commercial payers.
Understanding and experience working with in-house patient support services required.
Understanding of buy and bill process, patient services and specialty channel distribution preferred.
Familiarity with relevant legal and regulatory pharmaceutical industry requirements.
Experience leading and executing territory-level business planning activities.
Driver's license required, with the ability to travel 50%+ as needed, with occasional overnight travel as required.
Must be able to work evenings and weekends, as needed, for physician or patient events (both in person and virtual).
Depending on geography, must have the ability to manage a multi-state territory with diverse customer base.
The base salary range for this position is $160,000 to $210,000; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge. In addition to base salary, this position is eligible for participation in a competitive short term and long term incentive program based on performance and company results.
ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company
$57k-95k yearly est. Auto-Apply 60d+ ago
Network Engineer
Tris Pharma 4.2
Monmouth Junction, NJ job
Tris Pharma, Inc. (******************* is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.
Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success.
We have an opening in our Monmouth Junction NJ facility for an experienced Network Engineer.
The incumbent is a hands-on, internal user-focused member of our IT department responding in a timely fashion to internal queries and concerns, investigating and resolving IT problems, documenting all issues and escalating appropriate situations to IT management as needed.
ESSENTIAL FUNCTIONS
Primary duties/responsibilities
* Designs/Implements/Maintains existing Network Infrastructure
* Redesign existing Network Infrastructure based on current best practices
* Creates Technical Documentation as needed for the environment
* Monitors Network performance to determine if adjustments need to be made
* Maintains network infrastructure backups
* Replace faulty network hardware components when required
* Maintain, configure, and monitor EndPoint Security/Virus & malware protection
* Writes training documentation as needed
* Follows best practices for System Development Life Cycle (SDLC)
* Decommissions systems
* Manages Cisco Networking Infrastructure, which includes Network Switches and Firewalls. Creates rules and DMZs, as needed
* Manages Wireless Networks and identifies network issues and create solutions
* Creates and modifies network documentation utilizing Microsoft Visio
* Uses RADIUS, specifically Microsoft NPS, to create rules and troubleshoot network issues
* Manages DHCP, DNS, Networking, Firewalls (software and hardware), as needed
* Creates dashboards for monitoring
Requirements
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
Bachelors degree in Computer Science or IT Infrastructure degree and minimum 2 years related experience in an IT business environment, preferably pharmaceutical or biotechnology OR combination education and minimum 6 years' relevant experience as a Network Engineer in an IT business environment, preferably pharmaceutical or biotechnology.
* Experience with Endpoint Security REQUIRED
* Experience with Microsoft Server and Desktops, preferably Windows 10 and Windows Server 2019 and above REQUIRED
* Strong understanding and working knowledge of Office365 REQUIRED
* Strong working knowledge of Cisco IOS and routing protocols REQUIRED
* Strong working knowledge of VMWare REQUIRED
* Strong working knowledge of EMC storage REQUIRED
Work Arrangements: This position has some hybrid potential but requires selected candidate to be in office majority of the week.
Anticipated salary range: $150 to $180k/year. Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity.
Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.
Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-hybrid
$150k-180k yearly 3d ago
Project Process Engineer
Hikma Pharmaceuticals USA Inc. 4.9
Cherry Hill, NJ job
Job Title: Project Process Engineer
Job Type: Full-time
About Us:
As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.
Description:
We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Project Process Engineer. In this role, you will be responsible for overseeing all project aspects from conception to completion. Activities such as scope development, budgeting, design, procurement, scheduling, construction management, installation, and commissioning will be under your direction. In addition, as you become familiar with the site, you will provide technical expertise to troubleshoot and optimize systems and equipment. In this role, you will focus on projects and engineering support relating to site utilities/infrastructure, facilities, and HVAC.
Key Responsibilities:
Building systems and utilities such as site electrical infrastructure, compressed air, plant steam, chilled water, and condenser/tower water.
Critical utilities such as WFI, clean steam, and oil free process air.
Cleanroom HVAC equipment and BMS/BAS control, monitoring, and alarming systems.
A wide variety of facilities projects such as cleanroom construction, facility upgrades, cold storage chambers, stability chambers, warehouse upgrades, office area renovations, etc.
Qualifications:
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
Minimum: B.S. Degree in Engineering and five (5) years of project engineering or maintenance engineering experience.
Strong organizational skills and engineering knowledge.
Excellent communication and time management abilities.
Demonstrated ability to apply project management tools and techniques to engineering projects in multiple disciplines.
Technical investigation and troubleshooting skills especially related to HVAC issues.
Decision making ability and leadership skills.
Working knowledge of cGMPs as they relate to sterile pharmaceutical manufacturing.
Demonstrated knowledge of pharmaceutical manufacturing facilities, critical utilities, and production equipment with respect to their design, installation, and operation.
Strong proficiency with Microsoft Office.
Basic AutoCAD skills.
Experience with Siemens Apogee or Desigo is a plus.
Professional Engineering license or PMP Certification is a plus.
Preferred Qualifications:
Preferred: B.S. Degree in Mechanical Engineering and five to fifteen years of project engineering or maintenance engineering experience in the pharmaceutical industry.
Professional Engineering License with HVAC emphasis.
What We Offer*:
Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
3 personal days (prorated based on hire date)
11 company paid holidays
Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
Employee discount program
Wellbeing rewards program
Safety and Quality is a top organizational priority
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave
*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Recruiters:
Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.
Equal Opportunity Employer:
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
$71k-93k yearly est. 57d ago
Manager, Regulatory Affairs - U.S. Animal Health
Hikma Pharmaceuticals USA Inc. 4.9
New Jersey job
Job Type: Full Time
About Us:
As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.
Description:
We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Manager, Regulatory Affairs - U.S. Animal Health to join our team. In this role, you will be responsible for leading regulatory strategy and execution for Hikma's veterinary pharmaceutical portfolio, which includes, but is not limited to, injectables and oral solids This role ensures compliance with applicable regulations and supports product development, registration, and lifecycle management, acting as a liaison between the company and regulatory authorities. The ideal candidate will bring deep animal health regulatory expertise, strong project leadership, and a collaborative mindset to drive successful regulatory outcomes. This role will start out as an individual contributor role with the aim of supporting the build out of the animal health function at Hikma. Occasional travel to regulatory meetings or manufacturing sites will be required.
Key Responsibilities:
Develop and implement regulatory strategies for new and existing animal health pharmaceutical products
Prepare and manage regulatory submissions (e.g., JINAD, NADA, ANADA, supplements) to FDA-CVM authorities
Oversee the maintenance and accuracy of technical regulatory information to ensure high-quality, compliant submissions
Ensure ongoing compliance throughout the product lifecycle
Serve as animal health subject matter expert on cross-functional project teams and connect with other Hikma global regulatory experts, providing animal health-specific guidance from early development through lifecycle, offering strategic leadership and counsel across Clinical, Quality, and Business Development functions
Provide regulatory insight by, in coordination with the Legal function, interpreting legislation and translating it into clear, actionable guidance to improve project outcomes and predictability
Facilitate scientific advice and pre-submission consultations
Prepare and lead meetings with regulatory authorities
Monitor emerging regulatory changes and assess impact on Hikma's animal health portfolio
Manage regulatory documentation and ensure accuracy and completeness
Mentor other regulatory staff and contribute to team development
Prepare risk assessments and regulatory evaluations for complex issues
Maintain relationships with all regulatory bodies for animal health
Qualifications:
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
Bachelor's or Master's degree in life sciences, veterinary medicine, or related field.
Minimum 5 years of regulatory affairs experience in the animal health pharmaceutical industry
Strong knowledge of FDA-CVM regulations and submission pathways
Experience with pharmaceutical product development and lifecycle management
Excellent communication, organizational, and project management skills
Experience with clinical trial requirements is a plus
Preferred Qualifications:
Some experience with global regulatory submissions (e.g., EU, Canada)
Familiarity with eCTD and electronic submission platforms
Ability to interpret complex regulatory requirements and translate them into actionable strategies
Fluent in English; additional languages are a plus for global roles
Compensation:
Base Salary: $120,000 to $180,000 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.
What We Offer*:
Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
3 personal days (prorated based on hire date)
11 company paid holidays
Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
Employee discount program
Wellbeing rewards program
Safety and Quality is a top organizational priority
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave
*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Recruiters:
Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.
Equal Opportunity Employer:
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
$120k-180k yearly 58d ago
Associate Director, Medical Science Liaison (Nephrology)
ANI Pharmaceuticals 4.4
ANI Pharmaceuticals job in Princeton, NJ
About Us
Welcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products.
With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike. We understand the importance of accessibility, and our products are available across a wide range of therapeutic areas, contributing to the well-being of communities globally.
About the Role
The Medical Science Liaison (MSL) will serve as a liaison to the medical/scientific community and will be responsible for establishing, developing, and maintaining relationships with medical experts in Nephrology nationwide.
The MSL is a credentialed therapeutic and disease expert that engages in scientific exchange with leaders in both the external medical and scientific communities. MSLs are responsible for conducting medical/scientific interactions with designated HCPs, HCP organizations, payors, and other relevant entities, and supporting internal activities related to medical communications, information, research, education, and clinical development.
MSLs provide medical information and education through balanced scientific exchange and provide clinical and scientific support for ANI and the Medical Affairs department at the direction of Medical Affairs leadership.
Position Responsibilities
Always comply with company and compliance policies including internal and external guidelines
Maintain comprehensive, up-to-date scientific expertise of disease state, clinical information, product data, and the competitor landscape within the relevant therapeutic area(s), specifically Nephrology
Align day-to-day activities with Medical Affairs strategic objectives, with flexibility depending upon evolving needs of the organization
Establish scientific and clinical relationships with key opinion leaders and academic centers to expand research and educational opportunities for ANI products
Proactively engage with Scientific Leaders (SLs) and ensure the appropriate dissemination of clinical and scientific information regarding marketed and pipeline compounds in an unbiased and ethical manner
Provide study support from protocol and budget development to submission and completion for Phase IV research
Present healthcare professionals and decision makers with accurate, fair-balanced, and timely answers to unsolicited requests for information about ANI products
Develop and deliver highly specialized scientific/educational programs including but not limited to formulary presentations for managed care and related organizations
Document and forward reports of adverse events to appropriate ANI personnel promptly
Assist Medical Affairs as well as agency personnel in the development of presentations and slide kits
Actively participate in advisory boards, speaker training events, clinical investigator meetings, as well as regional, national, and international meetings when required
Actively participate in key medical and scientific conferences by staffing medical information booths and attending scientific sessions
Garner and document relevant and actionable insights, that inform strategy and tactics, promptly
Provide continuing field scientific support and training for commercial colleagues
Skills
Working knowledge of FDA and OIG requirements, as well as clinical trial design and statistics, is required
Strong presentation and interpersonal communication skills, both written and verbal; must be able to provide succinct and strategic insights that are timely and actionable to senior management
Ability to successfully interact with medical professionals at all levels, communicating complex scientific concepts with confidence
Strong clinical knowledge including pharmacotherapy, treatment guidelines, clinical research processes, medical expert engagement strategies, and FDA promotional guidelines, regulations, and ethical guidelines applied to the pharmaceutical industry is required
A proactive self-starter who can manage work and lead others independently, with the ability to see the next step and take appropriate action with minimal oversight and without prompting
Outstanding work ethic and integrity, including high ethical and scientific standards
Ability to efficiently manage multiple priorities with a flexible and solutions-oriented approach in a fast-paced, rapidly changing environment
Extensive travel is integral to the performance of this position. The candidate should be willing to travel and be able to thrive in a virtual environment
Education / Experience:
The qualified candidate will have an advanced degree in a health-sciences related field such as a PharmD, MD, PhD
Minimum of 3 years' prior Field Medical experience in the pharmaceutical industry
Previous experience in Nephrology preferred
The base salary range for this position is $190,000 - $220,000 ; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge. In addition to base salary, this position is eligible for participation in a competitive short term and long term incentive program based on performance and company results.
ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company.
Company Overview
ANI Pharmaceuticals, Inc. is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products. Our team is focused on delivering sustainable growth by building a successful Purified Cortrophin Gel franchise, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities.
At ANI Pharmaceuticals, there are opportunities to contribute to our purpose every day. We value authenticity, knowledge, and hard work, we strive to celebrate our employees in a positive environment. Our culture empowers everyone to be successful and apply our full potential.
#LI-REMOTE
Zippia gives an in-depth look into the details of Ani Pharmaceuticals, including salaries, political affiliations, employee data, and more, in order to inform job seekers about Ani Pharmaceuticals. The employee data is based on information from people who have self-reported their past or current employments at Ani Pharmaceuticals. The data on this page is also based on data sources collected from public and open data sources on the Internet and other locations, as well as proprietary data we licensed from other companies. Sources of data may include, but are not limited to, the BLS, company filings, estimates based on those filings, H1B filings, and other public and private datasets. While we have made attempts to ensure that the information displayed are correct, Zippia is not responsible for any errors or omissions or for the results obtained from the use of this information. None of the information on this page has been provided or approved by Ani Pharmaceuticals. The data presented on this page does not represent the view of Ani Pharmaceuticals and its employees or that of Zippia.
Ani Pharmaceuticals may also be known as or be related to ANI PHARMACEUTICALS INC, ANI Pharmaceuticals, ANI Pharmaceuticals Inc, ANI Pharmaceuticals, Inc., Ani Pharmaceuticals and Ani Pharmaceuticals, Inc.