Catalent Pharma Solutions jobs in Philadelphia, PA - 79 jobs
Material Handler
Catalent 4.4
Catalent job in Philadelphia, PA
Work Schedule: Monday-Thursday 2:00PM-12:15AM
100% on-site
This is a Union role
Catalent is a global leader in development, manufacturing, and clinical supply services for pharmaceuticals, biologics, and cell and gene therapies. Our 206,878 sq. ft. Philadelphia-area facility serves as the global Center of Excellence for Clinical Supply Packaging, offering GMP secondary packaging and clinical labeling services. We provide manual, semi-automated, and automated packaging solutions for studies of all sizes, including temperature-controlled and frozen packaging capabilities for sensitive products. Come and be part of a team that delivers industry-leading quality and innovation.
The Material Handler is responsible for performing all distribution tasks related to picking, verification, and packing. This is a great opportunity to build hands-on experience in a fast-paced GMP environment while contributing directly to the success of our manufacturing operations.
The Role:
Loads, unloads, and moves materials within S&D or M&P facilities and campus, performing any combination of following duties in a safe and compliant manner:
Reads work order (or follows oral instructions) to ascertain materials or containers to be moved.
Material transfers to or from storage or work areas to designated area, using rolling carts, hand trucks and industrial trucks or other devices.
Material transfers into vehicles operating hand trucks and industrial trucks according to method of conveying materials and equipment.
Material transfers onto or from pallets, racks, and shelves manually (by hand) according to method of conveying materials and equipment.
Transfer materials from wooden pallets to heat treated pallets / plastic pallets as required. Wipe off and collapse plastic containers as needed.
Pre-Stage, Stage and inventory transfer materials to locations as required.
Constantly being aware of their surroundings to ensure materials are in their correct storage environments in a timely manner by reading orders and identification labels to locate or relocate inventory.
Operate powered material handling equipment, fill batteries with water using an auto watering system and report any mechanical or electrical difficulties to Supervisor.
Attending forklift training and certification courses as required.
Transfer material between storage and shipping areas using a box truck (No CDL Required) and drop off packages to off-site destinations, if required.
Other duties as assigned
The Candidate:
High School Diploma or Equivalent is required
Forklift experience desired.
Must possess a valid driver's license.
Knowledge of Computers and Access Inventory System.
Must be able to read, write and speak English.
Must demonstrate the ability to read and understand customer specifications, cGMP's and SOP's.
Perform tasks in multi-temperature environments (between 30°C and -20ᵒC) using the appropriate personal protective equipment.
Ability to lift ~ 50lbs in a safe and compliant manner.
Good attendance
Up to 90-days probationary period.
Position Benefits:
Diverse, inclusive culture
Several Employee Resource Groups focusing on D&I
Dynamic, fast-paced work environment
Positive working environment focusing on continually improving processes to remain innovative
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
Competitive salary
Community engagement and green initiatives
Medical, dental and vision benefits effective after 90-day probationary period
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
$32k-39k yearly est. Auto-Apply 60d+ ago
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Production Scheduler
Catalent 4.4
Catalent job in Philadelphia, PA
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
This 206,878 square-foot facility, located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-IDâ„¢ safe storage labels for your studies. Single panel and Peel-IDâ„¢ safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.
Catalent Pharma Solutions in Philadelphia is hiring a Production Scheduler. The packaging operations team at the Philadelphia facility is responsible for overseeing pharmaceutical clinical and commercial packaging operations, including drug product and DEA controlled substance. Primary and secondary packaging operations are executed at ambient through frozen temperature conditions in three buildings across campus.
The Production Scheduler is responsible for developing and maintaining the detailed, short-term production schedules (daily to weekly) to optimize resource utilization within the actual, finite capacity of the plant. This includes daily collaboration between the Production Scheduler, Planning team and Packaging team and translating the plant schedule to ensure efficient, on-time production.
This is an onsite, full-time, hourly/salary role position: Monday-Friday: 8:00am-5:00pm -1st shift.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
The Role:
Accountable for translating the master plant schedule to provide the detailed packaging schedule in a manner that is effectively executed by the Operations teams.
Responsible for clearly communicating schedule changes, potential disruptions, and performance data to all relevant departments and teams.
Partners across functional departments to effectively support batch readiness on the packaging floor
Monitors and reports key performance indicators
Analyzes packaging and resource data to identify and implement adjustments in the planning and schedules operations and drive operational performance improvements
Identify opportunities for process improvements and implement best practices to enhance production and scheduling efficiency and effectiveness.
Maintain accurate documentation and records for audit purposes.
Provide training, mentoring and development of indirectly reporting employees
All other duties as assigned
The Candidate:
Requires a Bachelor's Degree; OR Associates Degree with at least 2 years of relevant work experience; OR a High School Diploma/GED with at least 5 years of relevant work experience
Knowledge of production scheduling operations
Fundamental understanding of clinical packaging requirements preferred
High-attention to detail and strong organizational skills
Experience working in an ERP and scheduling system; Orchestrate or JD Edwards preferred
Computer literate (Microsoft Office Suite)
Excellent communication and interpersonal skills
Ability to prioritize and manage multiple projects
Demonstrated indirect leadership and collaboration
Proven ability to adhere to and develop Standard Operating Procedures
Why you should join Catalent:
Defined career path and annual performance review and feedback process
Diverse, inclusive culture
Positive working environment focusing on continually improving processes to remain innovative
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
152 hours of PTO + 8 paid holidays
Several Employee Resource Groups focusing on D&I
Dynamic, fast-paced work environment
Community engagement and green initiatives
Generous 401K match
Medical, dental and vision benefits
Tuition Reimbursement - Let us help you finish your degree or start a new degree!
WellHub- program to promote overall physical wellness
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
$41k-57k yearly est. Auto-Apply 60d+ ago
Fill Operator I - 3rd Shift
Hikma Pharmaceuticals 4.9
Cherry Hill, NJ job
Job Title: Fill 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 Fill Operator I to join our team. In this role, you will be responsible for key responsibilities and tasks.
Key Responsibilities:
* Maintains curriculum gowning qualifications.
* Ability to perform all job duties using acceptable aseptic technique.
* Sets up & operates automated filling and support equipment such as fillers, stoppering units and cappers.
* Completes applicable paperwork and log book entries for the filling rooms in accordance with approved procedures.
* Follows all written procedures for operation of the fill room.
* Performs clean-up of equipment and room, including walls and floor, as necessary.
* Collects samples, performs fill weight checks and other quality checks as necessary.
* Assists with or performs preventive maintenance tasks on filling equipment, such as inspection and cleaning of machine parts, as may be required.
* Refers process issues to Supervisor or designee.
* Informs supervisor of maintenance and/or safety issues.
* Works overtime with short notice when production requires.
* Performs all other duties as determined by supervisor and management.
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: 1 year experience operating production equipment and /or operating analytical instrumentation or 2 (two) years as a Clean Room Operator required.
Preferred Qualifications:
* Prior aseptic technique training preferred but not required.
Language Skills:
* Good oral and written communication skills are essential. Must be able to document process issues in a clean, concise manner in accordance with cGMPs and SOPs.
Mathematical Skills:
* Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and 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. Ability to examine problem areas and make recommendations for corrective action. Must be able to comprehend and follow all applicable SOPs.
Physical Demands:
* Must be able to lift 15 lbs. Must be able to stand for long periods of time.
* The cleaning function of the position requires frequent bending, twisting, pushing, pulling and lifting.
* The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work Environment:
* Filling Operator I must work in filling suites totally gowned with mask, hood, coverall and gloves. At times environment can be confining. The noise level is moderate to loud. Use of hearing protection may be required. The use of sanitizing agents to clean the filling room may be moderately disagreeable. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Compensation:
Hourly Rate: $23.00 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
$23 hourly Auto-Apply 7d 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 7d ago
Medical Director - Ophthalmology
Parexel 4.5
Trenton, NJ job
**Parexel** is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values, Patients First, Quality, Respect, Empowerment & Accountability.
**Parexel is looking for a Medical Director with a very strong background in Ophthalmology to join our Global Medical Sciences team.**
**The role is remotely based in the US.**
The Medical Director is a medical expert with specialized therapeutic expertise and some experience across indications, clients and drug development. They initiate and maintain medical and consultative relationships with clients, consult on early engagement and pre-award efforts and serve as a medical monitor for contracted projects. The Medical Director may take on leadership roles by participating in initiatives, mentoring junior MDs and/or, where appropriate, managing a team of physicians.
Primary activities will focus on **Medical Monitoring Delivery & PV Support** . The medical monitor will independently deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor (i.e., tasks and time per task contracted) and according to the assigned role (Global Lead Physician or Regional Lead Physician).
**Medical Expertise** and experience in **Ophthalmology** is essential to the medical monitor role and will be manifested in high quality consultation on protocol development or drug development programs, medical review of various documents, collaboration on internal therapeutic area meetings, training module development, white papers, slide sets, publications etc.
**Client Relationship Building & Engagement,** including soliciting and addressing client feedback and suggestions regarding medical study-related activities, are core skills required of the medical monitor.
**Business Development:** the medical monitor will provide medical expertise / leadership in Proposal Development Teams (PDTs) for client bid pursuit meetings.
**Skills**
+ Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts
+ Client-focused approach to work
+ Excellent time management skills
+ Excellent verbal and written medical communication skills
+ Excellent standard of written and spoken English
+ A flexible attitude with respect to work assignments and new learning
+ Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
+ Willingness to work in a matrix environment and to value the importance of teamwork.
**Knowledge And Experience**
+ Experience in clinical medicine (general or specialist qualifications) with Fellowship or specialty training in **Ophthalmology** , which is expected to be kept up to date.
+ A background in clinical aspects of drug development, including all aspects of Medical Monitoring and study design/execution, preferred
+ Clinical practice experience
+ Good knowledge of the drug development process including drug safety, preferred
+ Experience in Pharmaceutical Medicine, preferred
+ Experience leading, mentoring and managing individuals/ a team, preferred
**Education**
+ US Board certified in **Ophthalmology**
+ Experience as a Physician in Industry or as a clinical trial investigator is required
+ Previous CRO experience is strongly preferred
+ Medically qualified in an acknowledged medical school with completion of at least basic training in clinical medicine (residency, internship)
The ability to travel 15% domestically or internationally is required.
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$187k-261k yearly est. 60d ago
Principal Medical Writer / Senior Medical Writer - US - FSP
Parexel 4.5
Trenton, NJ job
The Senior Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other Parexel departments and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical writing staff.
**Key Accountabilities** :
**Author Clinical Documents**
+ Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy.
+ Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input.
+ Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable.
+ Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
+ Review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing.
**Quality Control**
+ Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
+ Confirm data consistency and integrity across the document.
+ Prepare documents for publishing readiness, when applicable.
+ Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable.
+ Provide suggested alternative content when contributors provide content that does not meet document needs.
+ Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review.
**Document Project Management**
+ Act in the capacity of project manager/lead for medical writing projects, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management.
+ Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership: communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead/facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage/drive the timeline, and advance document development to approval, according to Parexel or client guidelines/SOPs. Distribute final documents to project team and client.
+ Identify any potential project challenges to departmental line management and project leader, including changes in project plan, timeline or out of scope requests, and suggest possible resolution options.
+ Attend or lead project team meetings as required. Mediate conflict or disagreement, as well as timeline delays, among team members by negotiating, compromising, and facilitating open exchange of ideas and opinions to come to a consensus.
+ Supervise collection of documentation by Medical Writing Support Coordinator, Document Specialist, and/or Associate Medical Writer for assembly of project files and client deliverables. Ensure appropriate filing of project documentation with assistance from the Medical Writing Support Coordinator.
+ Build and maintain collaborative relationships with teams/clients for an efficient, productive, and professional working relationship.
**Training/ Compliance**
+ Attend and complete mandatory, corporate, project-specific, and departmental training as required.
+ Keep abreast of professional information and technology through workshops and conferences (when approved), and assure appropriate transfer of that information to the department.
+ Assist in the training/mentoring of new staff as well as less experienced departmental members.
**General**
+ Attend departmental and company meetings as necessary.
+ Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform.
+ When requested, assist management with preparation of resourcing estimates for potential new medical writing projects, or review request for proposal packages to determine content and appropriateness of materials required for development of clinical documents.
+ Initiate and participate in departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, templates, and general guidelines for clinical documentation and workflow procedures.
**Skills:**
+ Excellent interpersonal, verbal, and written communication skills.
+ Ability to consistently produce documents of high quality.
+ Demonstrates attention to details and proactivity.
+ Ability to understand all necessary steps in a project, plan ahead, and identify critical paths.
+ A flexible attitude with respect to work assignments and new learning; readily adapts to changes.
+ Ability to efficiently manage time spent on tasks and proactively identify deficiency. Manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills.
+ Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity.
+ Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.
+ Understands and satisfies client needs.
+ Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services.
+ Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy.
**Knowledge and Experience** :
+ Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP.
+ Extensive clinical/scientific writing skills.
+ Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar.
+ Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel).
+ Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation.
+ If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite
**Education:**
+ Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.
\#LI-CF1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$95k-139k yearly est. 40d ago
Department Specialist
Hikma Pharmaceuticals 4.9
Cherry Hill, NJ job
Job Title: Department Specialist 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 Department Specialist. In this role, you will be responsible for administrative responsibilities for Reliability & Compliance Maintenance Work Order systems as well as departmental administrative duties including preparation of reports and requisitions.
Key Responsibilities:
* Regular and predictable onsite attendance and punctuality.
* Receive completed work orders and enters completion into appropriate system and close work orders.
* Receive Reliability & compliance Work Order requests and enter in system.
* Generate monthly list of work orders past their due dates and distribute to appropriate supervisor.
* Implement the equipment numbering system. Upon request for an identifying number for a piece of equipment, issue number from a Master list, maintain log and prepare ID tag for the equipment.
* Print weekly Reliability & Compliance work orders scheduled for completion and distribute to appropriate supervisor.
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.
* Experience in maintenance environment a plus.
* Excellent computer skills
* Knowledge in SAP
* Excellent communication and organizational skills
* Technical knowledge
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
Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge of FDA regulatory requirements and processes to a major, dedicated client partnership.
As a Senior Regulatory Affairs Associate, you will serve as the primary regulatory liaison with local health authorities (HAs), industry groups, and internal stakeholders. In this role, you will lead regulatory processes, ensure compliance with national legislation, and provide critical support for product launches, integrations, and lifecycle management activities.
This is a dynamic position that demands deep regulatory expertise, strong project management capabilities, and the ability to effectively influence
cross‑functional teams in a fast‑changing environment.
Key Responsibilities:
Documentation & Compliance
- Prepare, organize, and coordinate local documentation (e.g., Module 1) to meet national submission requirements.
- Maintain and update national systems in line with local legislation (renewals, PSURs, label updates, CMC changes).
- Execute timely data entry and validation in Veeva Vault RIMS for submissions and approvals.
Regulatory Submissions
- Review, prepare, and submit dossiers; negotiate with HAs to secure approvals.
- Provide local input for change control and post-approval requirements.
- Collaborate with global functions to obtain documentation aligned with local requirements.
Audit & Inspection Support
- Support RA representatives during audits/inspections, ensuring readiness and timely CAPA closure.
- Provide local expertise and responses to inspection queries.
Cross-Functional Collaboration
- Partner with Regulatory, Medical, Marketing, and Market Access teams to assess and mitigate impacts of regulatory changes.
- Act as the primary RA representative for local Commercial and Medical teams, translating business needs into actionable regulatory strategies.
Strategic Leadership
- Lead regulatory strategies for product launches and integrations at the affiliate level.
- Represent the company with local HAs, industry groups, and trade associations, fostering positive relationships.
- Provide critical support for promotional material review, interpretation of regulations, and implementation of local legislation.
Education
- Bachelor's degree in natural sciences (biology, chemistry with pharmacological focus) or equivalent.
- Advanced degree (Master's or PhD) preferred in law, legal affairs, or natural sciences.
- Regional Regulatory Affairs Certification (RAC, CARP, CHPC) is a plus.
Experience
- 3-5+ years of local regulatory knowledge and experience in a health authority-facing role.
- Demonstrated previous life cycle management experience is required.
- Comprehensive understanding of regional and global regulatory requirements, guidelines, and processes.
- Proven expertise in managing regulatory submissions, timelines, and cross-functional teams.
- Strong project management and leadership skills.
- Experience influencing Commercial Operations stakeholders and driving business-critical decisions.
- Demonstrated ability to adapt and succeed in rapidly changing environments.
\#LI-LB1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
We are looking to fill a **Scientist III - (HPLC) Chromatography - Separations & Molecular Biology - Immunoassay Experience** position working as **a full-time employee of Parexel FSP on long-term assignment** onsite at one of our clients located in **Rahway, NJ.** This position offers full benefits, sick time, 401K, paid holidays, and paid time off. **This position does not offer any sponsorship.**
**Description**
Support of routine bioanalytical testing of samples from cell-line development, in-process, process development/characterization, forced degradation, release & stability, and pre-formulation. Other potential opportunities include method development/optimization, workflow optimization, and template development.
**Responsibilities**
+ Support of high-throughput, pre-formulation, pre-qualification, robustness, or admixture testing
+ Results processing and documentation by following appropriate methods / protocols / procedures
+ Sample management and monitoring of controlled temperature units.
+ Following all appropriate laboratory safety and hygiene procedures
**Qualifications**
+ BA/BS (3-5 yrs.) of relevant experience in analytical chemistry or biologics testing lab
+ MS (1-2 yrs.) of relevant experience in analytical chemistry or biologics testing lab
**Required Skills and Experience**
+ Must have separations experience for large molecules or plate-based assay experience.
+ Experience in analyzing biologics including monoclonal antibodies and/or other therapeutic proteins using at least one of the following techniques:
+ Liquid Chromatography (HPLC / UPLC)
+ Protein A Titer, Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX, AEX, CEX), Reverse Phase (RP), or Hydrophobic interaction chromatography (HIC)
+ Electrophoretic methods such as capillary electrophoresis sodium dodecyl sulfate (CE-SDS) and/or capillary isoelectric focusing (cIEF)
+ ELISA (HCP, proA) and binding potency assay
+ qPCR and basic molecular biology techniques (gel electrophoresis, etc.)
+ High-throughput liquid handling system, e.g., Tecan, Bravo, etc.
+ Basic instrumentation troubleshooting
+ **Ability and willingness to train in molecular biology and immunoassay testing**
+ **Familiarity with Microsoft Office Applications (Outlook, Excel, Word, PowerPoint, OneNote, Teams, etc.)**
**Desired Skills and Experience**
+ Familiarity with compendial testing such as UV 280, pH, and Physical Observations
+ **Ability to follow complicated scientific protocols / procedures**
+ Making accurate reagent preparations (dilutions / solutions / buffers / mobile phases)
+ Good documentation practices & utilization in electronic lab notebooks (ELN)
+ Analytical software such as Empower.
+ Knowledge of Laboratory Information Management Systems (LIMS)
+ Sample submission & sample management
+ Monitoring of controlled temperature units
+ Experience with BSL2 (Biosafety Level 2)
**About Parexel**
Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies.
For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement.
**Come join us!**
\#LI-DK1
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$79k-113k yearly est. 60d+ ago
Process Operator I - PFS - 3rd - Shift
Hikma Pharmaceuticals 4.9
Cherry Hill, NJ job
Job Title: Process Operator I - PFS 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 8d ago
Quality Assurance Document Control Associate
Catalent 4.4
Catalent job in Philadelphia, PA
Quality Assurance Document Control
Work Schedule: Monday - Friday, 8:00am-4:30pm
100% on-site
Catalent's 206,878-square-foot Philadelphia-area facility serves as the global Center of Excellence for Clinical Supply Packaging, offering GMP secondary packaging and clinical labeling services. The site provides manual to fully automated packaging solutions, including temperature-controlled options for sensitive products. Come and be part of a team that delivers industry-leading quality and innovation.
The Quality Assurance Document Control role is responsible for preparing customer files, reviewing and approving batch records, and releasing finished products while serving as the primary liaison with customer quality teams. This position works closely with operations, production, project management, shipping, and quality groups to ensure timely and compliant batch record review and release. It's an excellent opportunity to build hands-on experience in a fast-paced GMP environment, contribute directly to product quality, and collaborate with leading pharmaceutical partners in a global setting.
The Role
Review and approve batch records before production to ensure compliance with cGMP, clinical trial protocols, and blinding requirements.
Monitor production schedules and attend planning meetings as needed to align QA activities with operational priorities.
Review completed batch records for accuracy, protocol adherence, and procedural compliance.
Verify randomization schedules are correctly applied for patient treatment group assignments.
Serve as the primary liaison with clients for batch record review and release.
Collaborate with cross-functional teams to resolve documentation issues and ensure compliance with regulations, procedures, and client requirements.
Ensure timely batch release to meet protocol initiation dates and update scheduling and inventory systems (e.g., JDE).
Record, track, and analyze documentation errors to maintain and improve departmental quality metrics.
Support and coach new QA Document Control staff while promoting a positive, safety-focused work environment.
Maintain organized document archives and ensure compliance with EH&S, 5S, and quality system requirements.
Other tasks or projects as assigned.
The Candidate
High school diploma or GED with a minimum of 5 years of GMP experience in a quality or manufacturing role within a regulated environment OR
Associate's degree with a minimum of 2 years of GMP experience in a quality or manufacturing role within a regulated environment OR
BA/BS degree with a minimum of 1 year of experience in a quality or manufacturing role within a GMP regulated environment
Experience with inspections or batch record review strongly preferred
Good organizational/time management skills and ability to multi-task
Challenges status quo and initiates improvements
Advanced computer skills - including a high level of proficiency in Microsoft Office including Excel, Work, Outlook, IE, SAP/JDE preferred
Experience with inspections or batch record review strongly preferred
Good organizational/time management skills and ability to multi-task
Challenges status quo and initiates improvements
Advanced computer skills - including a high level of proficiency in Microsoft Office including Excel, Work, Outlook, IE, SAP/JDE preferred
Why you should join Catalent:
Defined career path and annual performance review and feedback process
Diverse, inclusive culture
Positive working environment focusing on continually improving processes to remain innovative
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
152 hours of PTO + 8 paid holidays
Several Employee Resource Groups focusing on D&I
Dynamic, fast-paced work environment
Community engagement and green initiatives
Generous 401K match
Medical, dental and vision benefits
Tuition Reimbursement - Let us help you finish your degree or start a new degree!
WellHub- program to promote overall physical wellness
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
$51k-69k yearly est. Auto-Apply 33d 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 6d 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 37d ago
Quality Program Manager
Catalent 4.4
Catalent job in Philadelphia, PA
Work Schedule: Monday - Friday, 8:00am - 4:30pm
100% on-site
Catalent's 206,878-square-foot Philadelphia-area facility serves as the global Center of Excellence for Clinical Supply Packaging, offering GMP secondary packaging and clinical labeling services. The site provides manual to fully automated packaging solutions, including temperature-controlled options for sensitive products. Come and be part of a team that delivers industry-leading quality and innovation.
This position is responsible for being the quality liaison between Philadelphia Quality Assurance and the client. Specific clients will be assigned to each Quality Program Manager with whom they will support and develop a Quality relationship. The Quality Program Manager must be flexible and have well-developed organizational skills and the ability to interact with all levels within the organization.
The Role:
Work closely with Catalent Philadelphia site to obtain necessary quality information for clients to support their projects and requests
Plan, schedule, manage, and host customer, corporate, and internal audits. Support regulatory inspections as required
Track audit reporting, drive completion of Catalent response to audit findings, and closure of audit actions
Attend project kick-off meetings to assist various departments with understanding the project from a Quality perspective
Attend client preparation calls and visits to ensure that the client receives any appropriate documentation requested and get questions answered
Act as the primary contact person for client-specific quality questions and be the quality liaison between client and Catalent staff; Act as the primary contact with clients if there are quality questions on documentation, process questions, issues, etc
Be knowledgeable about customer-specific requirements. Ensure they are built into the process and communicated to relevant Catalent staff
Review deviation and complaint reports and address trends. Prepare communications regarding the results where appropriate and requested
Other duties as assigned
The Candidate:
Bachelor's degree is required, life sciences or scientific degree is preferred
Five years of relevant experience working in a pharmaceutical industry or life science industry is required
Must possess regulatory and/or client audit experience
Must have the ability to present Quality/ Compliance information both internally at Catalent and externally to clients
Knowledge of cGMP's is required
Why you should join Catalent:
Defined career path and annual performance review and feedback process
Diverse, inclusive culture
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
152 hours of PTO + 8 paid holidays
Generous 401K match
Medical, dental and vision benefits
Tuition Reimbursement - Let us help you finish your degree or start a new degree!
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
$97k-126k yearly est. Auto-Apply 20d ago
Investigator Financial Analyst II
Parexel 4.5
Trenton, NJ job
Parexel is looking for changemakers who are driven by curiosity, passion, and optimism. Come join us in keeping the Patient at the Heart of Everything We do. **Job Title** : Investigator Financial Analyst II **Job Introduction** : At Parexel, we are a leading Clinical Research Organization company specializing in delivering life-changing medicines to patients. We are seeking an **Investigator Financial Analyst** **II** to join our team. As an Investigator Financial Analyst, you'll be joining a fast-paced, driven environment that's helping to make life-changing differences to patients by steering the investigator budget management for crucial projects. Through the collaboration and diversity of the Investigator Payment Division the Investigator Financial Analyst is provided with opportunities to excel and discover where your skills can take you.
**Who we are looking for** :
Curious individuals interested in understanding investigator budget economic drivers. Who are detailed-oriented while assisting in translating the clinical conduct into a financial impact and proactively advising the project leader and the project financial analyst on how to influence critical budget and cash flow levers to prevent negative impact project financials.
**What you'll do** :
+ Lead the monthly investigator payment forecast cycle and support project analysis requirements, including a review of accruals, costs incurred, contracts signed, and patients enrolled.
+ Collaborate with clients, clinical team members, and other members of the organization to gather information and/or explain the financial impact of the observed clinical conduct.
+ Manage all required variance analyses for the set of projects, with insight and identify risks in the project forecast and to the budget.
+ Present updates on financial status of investigator payments for assigned projects and create information in response to client financial reporting needs for assigned projects in the area of project reporting, forecasting, or transactional details for the projects within the portfolio.
**Why join us:**
Be part of groundbreaking projects that are pushing the boundaries of the industry.
Experience a collaborative and inclusive work environment that highly appreciates your expertise.
Unlock your full potential with professional growth and development opportunities.
Enjoy work life balance and flexible working hours.
**Parexel US Benefits** :
+ Health, Vision & Dental Insurance
+ Tuition Reimbursement
+ Vacation/Holiday/Sick Time
+ Flexible Spending & Health Savings Accounts
+ Work/Life Balance
+ 401(k) with Company match
+ Pet Insurance
Full list of benefits available here: ***********************************
**About Parexel International:**
At Parexel we embrace flexibility and understand that in today's fast-paced world, employees need to balance their careers with their personal lives. Come join us where learning is constant, and you're exposed to a world of experiences and open doors.
If this job does not sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$89k-145k yearly est. 14d ago
Scientist III - Third Shift - Analytical Chemist Pilot Plant - FSP
Parexel 4.5
Trenton, NJ job
We are looking to fill a **Scientist 3 -** **Third Shift** **Analytical Chemist Pilot Plant** position working as **a full-time employee of Parexel FSP on long-term assignment** onsite at one of our clients located in **Rahway, NJ** . This position offers full benefits, sick time, 401K, paid holidays, and paid time off.
**Description**
The Scientist III **Third Shift** - Analytical Chemist Pilot Plant operates and maintains a myriad of analytical instrumentation and other duties as assigned by the client.
**Responsibilities**
+ Experience in routine and real-time testing for high-performance liquid chromatography (HPLC), gas chromatography (GC), ultraviolet (UV) spectroscopy, infrared (IR) spectroscopy, titrations, Karl Fischer (KF) testing, and other wet chemistry methods
+ Experience in HPLC and GC is required with an interest in expanding the knowledge and background in method development and optimization, validation, data analysis, and sample preparation techniques
+ Routine use of modern analytical techniques such as HPLC, GC, KF, ultraviolet-visible spectroscopy (UV-VIS), and IR spectroscopy
+ Comfortable working in a cGMP environment; knowledgeable in various GMP analytical activities, such as documentation procedures, abiding by relevant department SOPs and generation and second scientist review of GMP data
+ Experience with automated liquid handling systems (Tecan) for high throughput testing
+ Experience with a myriad of software platforms used in the compilation, processing, and reporting of data, such as Waters Empower, Relational Laboratory Information Management System (RLIMS), Lab X, etc.
**Qualifications**
+ BA/BS (3-5 yrs.) of relevant experience in n chemistry or a related discipline testing lab
+ MS (1-2 yrs.) of relevant experience in chemistry or a related discipline testing lab
**Desired Skills and Experience**
+ Effective organizational, multi-tasking, and oral/written communications skills
+ Ability to work under pressure and provide reliable results with quick turnarounds
+ Consistently deliver high quality and fully compliant results and interact with a diverse customer base daily
+ Proficient in written and spoken English, is required
**About Parexel**
Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies.
For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement.
**Come join us!**
\#LI-DK1
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$84k-114k yearly est. 15d ago
Distribution Project Coordinator
Catalent Pharma Solutions 4.4
Catalent Pharma Solutions job in Philadelphia, PA
**_Distribution Project Coordinator_** + **Work Schedule:** M-F 8am-4:30pm + 100% on-site _This 206,878 square-foot facility, located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes._
**_Catalent Pharma Solutions in Philadelphia, PA is hiring a Distribution Project Coordinator._** _ The Distribution Project Coordinator is responsible for managing distribution for clinical trial protocols, maintaining strong client relationships, and working closely with project management for study specific setup._
**The Role:**
+ Work with Project Management to define study specific distribution needs
+ Coordinate and dispatch shipments of clinical trial material to clinical sites
+ Anticipate and rectify distribution problems, reporting findings back to PM & the client
+ Understand customer expectation to be sure execution is in alignment with agreed scope of services
+ Own customer order pipeline (current orders and any backlog) including responsibility to guide S&OP teams and Distribution on upcoming orders from the customers
+ Coordinate with Distribution Department to manage scheduling of international and large volume shipments
+ Understand and adhere to standard operating procedures (SOPs) in a GMP setting
**The Candidate:**
+ Associate degree or equivalent work experience is required; Bachelor's degree is preferred
+ 2+ years of Customer Service experience in a cGMP regulated environment is preferred
+ Strong computer skills are required - (including, but not limited to, Microsoft Word, Power Point, and Excel and ability to quickly learn new systems/programs)
+ Distribution and cold-chain experience are preferred. Knowledge and experience in cGMP and FDA regulations is preferred. Knowledge of exporting clinical trial materials is preferred. ERP system experience; JD Edwards preferred
+ **Physical requirements:** Individual may be required to sit, stand, walk regularly and occasionally lift up to 10 pounds; ability to communicate orally with customers, vendors, and co-workers. Regular use of telephone and email. Hearing, vision, and speaking within normal ranges is essential for normal conversations, to receive ordinary information and to prepare or inspect documents. Good manual dexterity for the use of common office equipment such as computer terminals, calculator, copiers, and fax machines. Good reasoning ability is important. Able to understand and utilize management reports, memos, and other documents to conduct business
**Why you should join Catalent:**
+ _Defined career path and annual performance review and feedback process_
+ _Diverse, inclusive culture_
+ _19 days of PTO + 8 paid holidays_
+ _Several Employee Resource Groups focusing on D&I_
+ _Dynamic, fast-paced work environment_
+ _Employee Stock Purchase Program_
+ _Positive working environment focusing on continually improving processes to remain innovative_
+ _Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives_
+ _Competitive salary with possible bonus potential_
+ _Community engagement and green initiatives_
+ _Generous 401K match_ _and Paid Time Off accrual_
+ _Medical, dental and vision benefits effective day one of employment_
+ _Tuition Reimbursement_ _-_ _Let us help you finish your degree or earn a new one!_
+ _GymPass program to promote overall physical wellness_
+ _Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories_
**Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers (*********************************** to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .
$43k-64k yearly est. 60d+ ago
Project Process Engineer
Hikma Pharmaceuticals 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.
Location:
Cherry Hill, NJ, US, 08003
Nearest Major Market: Philadelphia
$71k-93k yearly est. Auto-Apply 60d+ ago
Cagewash Technician
Charles River Laboratories 4.3
Horsham, PA job
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.
**Job Summary**
We are seeking a Cagewash Technician for our Safety Assessment site located in Reno, NV.
The Cagewash Technician will assist in cleaning and disinfecting animal housing, feed and water containers using the automated cage washer, and cleaning of laboratory areas. This individual will also be responsible for recording all required tasks on relevant logbook records accurately and completely. The Cagewash Technician will also assist with animal care technical duties such as changing liners and sanitizing animal room walls and floors.
**Job Qualifications**
The following are minimum requirements related to the Cagewash Technician position:
* High School diploma or General Education Degree (G.E.D) preferred, but not required.
* No experience necessary.
* An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
* While performing the duties of this job, the employee is regularly required to talk, hear, and lift.
* Specific vision abilities required by this job regularly requires close vision and the ability to adjust focus.
* Must be able to regularly lift and manipulate up to 50 pounds on a repetitive basis each day.
Salary: The pay range for this position is $20.00 USD per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
**About Safety Assessment**
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.
**About Charles River**
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.
**Equal Employment Opportunity**
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit ***************
231870