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The Production Lead supports clinical trial projects through the packaging of clinical trial supplies; ensuring that all work is carried out in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). The CSS Production Lead is responsible for the overall process for the area, ensuring on-time startup and effective a...

","descriptionText","Packaging Lead LanceSoft Creative & Design Production Lead The Production Lead supports clinical trial projects through the packaging of clinical trial supplies; ensuring that all work is carried out in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). The CSS Production Lead is responsible for the overall process for the area, ensuring on-time startup and effective a...","shortDescription","Production Lead

The Production Lead supports clinical trial projects through the packaging of clinical trial supplies; ensuring that all w...","location","San Diego, California, United States, 92101","companyName","LanceSoft","salaryMin","salaryMax","salaryDescription","https://us.thebigjobsite.com/redirectfeedjob?jobid=EABDD7C8B4A5637867D42277FDE42B51&source=mediabistroxmlus&utm_source=mediabistroxmlus&jobSiteKey=39A1959E04323F9024BF96697F5042AB","companyDescription","companyWebsite","displayLogo","https://www.mediabistro.com/public/images/desk-100x50.webp","displayThumbnail","displayHeadline","Work at LanceSoft","isManualPosted","costPerClick",0.15,"displayUrl","fullUrl","https://www.mediabistro.com/jobs/2704888809-packaging-lead","strippedDescription","Production LeadThe Production Lead supports clinical trial projects through the packaging of clinical trial supplies; ensuring that all work is carried out in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). The CSS Production Lead is responsible for the overall process for the area, ensuring on-time startup and effective a...","parsedLocation",{"_467":468,"_469":470,"_471":472,"_473":194,"_474":194,"_475":476},"city","San Diego","state","California","country","United States","street1","street2","postal_code","92101","displayPublishedAt","3 days ago","shortTitle","shortLocation","level","searchCompanyPath","/jobs?keyword=LanceSoft","searchLocationPath","/jobs?location=San+Diego%2C+California%2C+United+States%2C+92101","searchTitlePath","/jobs?keyword=Packaging+Lead","featuredCompany",{"_425":490,"_15":374,"_491":428,"_74":-5,"_492":493,"_243":494,"_442":495,"_496":-5,"_497":498,"_499":-5,"_500":501,"_502":503,"_504":505,"_452":506,"_460":507,"_454":508},1072,"agency","slug","hearst-television","

Every career with Hearst Television is like a story. How it develops, where it takes you, the milestones you reach along the way – you’ve got a lot to look forward to as your unique career story unfolds. Hearst Television, a subsidiary of Hearst, owns and operates local television and radio stations serving nearly three dozen U.S. cities, reaching 24 million U.S. television households. Through its partnership with nearly all major networks, Hearst Television distributes national content across more than 120 video channels, including programming from ABC, NBC, CBS, CW, MY Net, MeTV, This TV, Estrella, and more. Hearst Television is recognized as one of the industry's premier companies. It has been honored with numerous awards for distinguished journalism and industry innovation, including the Walter Cronkite Award for political journalism, the national Edward R. Murrow Award, the DuPont-Columbia Award, and the George Foster Peabody Award.

","New York, NY","coloredLogo","logoAttachment","Hearst.png","thumbnail","thumbnailAttachment","Hearst_TV_Careers.png","hexCode","#2D75B9","headline","National multimedia company reaching 24 million households","https://production-rails-default.s3.amazonaws.com/uploads/company/logo_attachment/1072/Hearst.png","/companies/hearst-television","https://production-rails-default.s3.amazonaws.com/uploads/company/thumbnail_attachment/1072/Hearst_TV_Careers.png","hasJobSubmission","isSavedJob","similarJobs",[513,522,536,550,561],{"_429":428,"_433":514,"_452":453,"_444":445,"_243":515,"_440":516,"_427":428,"_111":436,"_431":194,"_432":194,"_454":453,"_442":517,"_425":518,"_455":456,"_430":115,"_477":519,"_460":520,"_479":436,"_480":517,"_482":483,"_484":521,"_486":487},["D",1772294400000],"Job Description\nThe Production Lead supports clinical trial projects through the packaging of clinical trial supplies; ensuring that all work is carried out in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). The CSS Production Lead is responsible for the overall process for the area, ensuring on-time startup and effective and compliant processing through the shift. The Production Lead ensures that all lines have the proper staff, support, and training to execute the production batch records. This position reports to the Production Manager.

Education and Experience

Bachelor’s degree required or equivalent relevant work experience.

Minimum of 6 years of industry experience, clinical trial packaging, or related packaging/manufacturing/operations experience required.

Minimum of 4 years of leading teams.

Essential Functions

Accurately review packaging batch records prior to packaging process to ensure processing instructions are followed in accordance with SOPs.

Prepare and complete documentation in compliance with SOPs and cGMP.

Review packaging batch records for completeness and appropriate documentation and ensure that any corrections to the packaging batch record are completed accurately.

Inspect drug product, components, and clinical labels for defects, blemishes or missing text prior to and during production.

Proficiently perform Job Safety Analysis (JSA) on new equipment.

Ability to analyze processes, recommend changes and drive improvements.

Trained in the use of Entropy (safety system) and TrackWise (quality system).

Perform Gemba walks.

Use visual management boards and signage.

Support supervisor in daily activities.

Assist with Safety and Quality investigations, utilizing Root Cause Assessment techniques, and CAPA identification.

Must have a “Patient First” customer focus mindset.

Will reinforce and support a respectful and professional workplace among all team members.

Must be able to successfully manage competing priorities and personalities.

Provide front line leadership support and decision making to staff and act as supervisor for Packaging and Room operations when Supervisor is unavailable or needed.

Assist with action item completions (e.g., corrections in TrackWise).

Assist with scheduling planned maintenance activities for equipment and facilities and any corresponding return to service.

Attend project kickoff meetings and effectively contribute to the plan.

Monitor Ready-to-Execute and coordinate on-time start activities for production.

Review equipment and room setups against JSAs, batch records, and SOPs – make changes accordingly to drive compliance and productivity.

Capture daily information from Short Interval Control boards and populate daily shift notes as well as other required metric sheets.

Other duties as assigned.

Knowledge/Skills Requirements

Demonstrated ability to read, write, and communicate effectively.

Proven written and verbal communication skills.

Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Ability to work in a team environment.

Strong organizational skills in alignment of Lean Six Sigma 5S standards.

Ability to work effectively under pressure to meet competing workplace demands while maintaining the highest level of quality in all work performed.

Proficient computer skills – including, but not limited to e-mail, Microsoft Word, Microsoft Excel, Internet Explorer, Inventory Systems, Quality Systems, Supply Flex.

Strong mathematical skills.

Proven leadership and team management skills.

Ability to communicate and collaborate with external vendors if necessary.

#J-18808-Ljbffr\n","Job Description\nThe Production Lead supports clinical trial projects through the packaging of clinical trial supplies; ensuring that all work is ca...","San Diego, California, United States, 92189",["B","2728157588"],"1 days ago","/jobs/2728157588-packaging-lead","/jobs?location=San+Diego%2C+California%2C+United+States%2C+92189",{"_429":428,"_433":523,"_452":453,"_444":524,"_243":525,"_440":526,"_427":428,"_111":527,"_431":194,"_432":194,"_454":453,"_442":528,"_425":529,"_455":530,"_430":115,"_477":531,"_460":532,"_479":527,"_480":528,"_482":533,"_484":534,"_486":535},["D",1771732800000],"Careers Integrated Resources Inc","Packaging Tech

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.\nJob Description

Under the guidance of immediate manager, works in conjunction with other Packaging Technicians on packaging of assigned products.\nWorks on the most basic assignments following detailed instructions, which incorporate Standard Operating Procedures (SOPs), Master Batch Records and current Good Manufacturing Practices (cGMPs).\nAssists in the inspection of Client products, Clinical Trial Material, and components.\nAssists in the labeling and packaging of Client products and Clinical Trial Material.\nPrepares cleaning solutions and cleans packaging areas, including walls, ceilings, floors, and equipment.\nComplies with all safety-related procedures and practices personally and in area.\nTakes variant action only with approval of department management.\nReceives well-defined instructions on majority of assigned work.\nDirect # - (732)-844-8715

","Packaging Tech

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce...","Packaging Tech","San Dimas, California, United States, 91773",["B","2659746288"],"Work at Careers Integrated Resources Inc","8 days ago","/jobs/2659746288-packaging-tech","/jobs?keyword=Careers+Integrated+Resources+Inc","/jobs?location=San+Dimas%2C+California%2C+United+States%2C+91773","/jobs?keyword=Packaging+Tech",{"_429":428,"_433":537,"_452":453,"_444":538,"_243":539,"_440":540,"_427":428,"_111":541,"_431":194,"_432":194,"_454":453,"_442":542,"_425":543,"_455":544,"_430":115,"_477":545,"_460":546,"_479":541,"_480":542,"_482":547,"_484":548,"_486":549},["D",1771516800000],"Almac Sciences","A pharmaceutical solutions provider is seeking Production Operators in Durham, North Carolina. The role involves packaging, assembly, and labeling material under strict quality control standards, ensuring compliance with SOPs and cGMP. Candidates must have a high school diploma and 1+ years of applicable work experience, especially in a pharmaceutical setting. Offering competitive benefits, this position is vital for maintaining product integrity and patient safety.\n#J-18808-Ljbffr\n","A pharmaceutical solutions provider is seeking Production Operators in Durham, North Carolina. The role involves packaging, assembly, and labeling ...","Cold-Chain Pharma Packaging Operator","Durham, North Carolina, United States, 27703",["B","2633539988"],"Work at Almac Sciences","10 days ago","/jobs/2633539988-cold-chain-pharma-packaging-operator","/jobs?keyword=Almac+Sciences","/jobs?location=Durham%2C+North+Carolina%2C+United+States%2C+27703","/jobs?keyword=Cold-Chain+Pharma+Packaging+Operator",{"_429":428,"_433":551,"_452":453,"_444":552,"_243":553,"_440":554,"_427":428,"_111":555,"_431":194,"_432":194,"_454":453,"_442":517,"_425":556,"_455":557,"_430":115,"_477":519,"_460":558,"_479":555,"_480":517,"_482":559,"_484":521,"_486":560},["D",1772276400000],"Clinical Network Services","Vanguard Clinical, Inc. is a Contract Research Organization (CRO) headquartered in San Diego, CA. Our mission is to bring innovation to clinical trial execution through passion, transparency, co-active communication, and integrity, to facilitate the successful development of life-changing medicines and therapies.

We are experts in clinical trial operations with a focus on Clinical Trial Management, CRO/Vendor Oversight, Trial Master File Management, Clinical Monitoring, Quality Assurance, Data Management and Study Startup. As a small company, we are highly adaptable, flexible, and transparent. Our unwavering integrity forms the foundation for our strong relationships both internally and as a partner to our Sponsor clients. Beginning with study development, we bring a “white glove service” approach to clinical trials. Our flexible approach and ongoing process development ensure efficiency and adequate resourcing, allowing us to respond rapidly to our clients’ needs as they evolve.

Our talented team is driven by passion and purpose, which has afforded us the opportunity to successfully lead clinical programs for pharmaceutical, medical device and biotechnology companies of all sizes in a variety of therapeutic areas. Our mission is to conduct clinical trials with outstanding quality on behalf of our clients to bring new drugs to market with the utmost integrity and confidence in the results.

Position Overview\nThis is an exciting opportunity to join a young and lively company in a fast-paced and dynamic environment. The Director, Business Development is responsible for all phases of the development of the company’s future revenue stream through new account targeting and development.

Essential Duties & Responsibilities

Develop and generate new business development leads.

Work with targeted business development accounts to secure future business.

Develop and implement projects, programs and strategies to accomplish corporate objectives.

Develop materials and presentations demonstrating CRO services according to client specifications and needs.

Prepare and/or assist in the preparation of price quotations, terms of sale and timelines according to company policy and within corporate guidelines.

Monitor monthly time and activity versus productivity to assess and implement continuous improvement.

Interview prospective new team members.

Supervise and conduct employee training/continuing education and performance evaluations.

Other duties as assigned.

Experience & Skills

A business background in the sales, training, marketing or purchasing of clinical service offerings for CROs, FSPs, and/or consulting businesses in the drug or device development space.

7+ years in pharmaceutical, medical device or related experience highly preferred.

Strong experience in computer technology, including CRM usage.

Foundational background/knowledge regarding medical terminology, drug nomenclatur e, clinical operational offerings.

Demonstrated character and transparency in prior business ventures.

Possesses a true passion for improving patient outcomes through the clinical development process.

Good written and oral communication skills.

Ability to work independently and be self‑motivated.

Ability to function as a team member.

Ability to lead and delegate to others.

Ability to identify client needs/opportunities and translate them into new projects.

Excellent interpersonal communication skills.

Ability to interact and develop a rapport with clients.

Education\nBachelor's degree in life science from an accredited college or university is strongly preferred; may be replaced by relevant experience. Other bachelor's degrees with relevant industry experience will be considered.

Travel\nTravel of up to 75% may be required.

Compensation Range\nFull-time Position: $130,000 -$160,000 base pay with generous uncapped commission structure + benefits package and annual performance bonus (Includes: health insurance, 401k retirement plan, and paid days off)

Consultant Rate: will be DOE

COVID-19 Vaccination\nTo protect the health and safety of our employees and to comply with client requirements, Vanguard Clinical may require employees in certain positions to be fully vaccinated against COVID-19, subject to reasonable accommodations or exemptions for religious, medical, or other legally protected reasons. Vaccination requirements will depend on the client site requirements. Proof of vaccination may be required, in accordance with applicable laws.

Equal Opportunity Employer\nVanguard Clinical is an equal opportunity employer for all applicants and employees. Vanguard Clinical prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

#J-18808-Ljbffr\n","Vanguard Clinical, Inc. is a Contract Research Organization (CRO) headquartered in San Diego, CA. Our mission is to bring innovation to clinical tr...","Director, Business Development",["B","2726112610"],"Work at Clinical Network Services","/jobs/2726112610-director-business-development","/jobs?keyword=Clinical+Network+Services","/jobs?keyword=Director%2C+Business+Development",{"_429":428,"_433":562,"_452":453,"_444":563,"_243":564,"_440":565,"_427":428,"_111":566,"_431":194,"_432":194,"_454":453,"_442":517,"_425":567,"_455":568,"_430":115,"_477":569,"_460":570,"_479":566,"_480":517,"_482":571,"_484":521,"_486":572},["D",1772200800000],"ALLTECH CONSULTING SVC INC","Job Description:

SUMMARY OF ESSENTIAL FUNCTIONS:\nThis position reports directly to the Production Manager. This position must be able to work in a team environment to offer quality packaging and labeling of customer’s clinical trials. Employees will be involved with handling look-alike products and labeling. Clinical operations can be run as a blister fill, bottle fill, pouch, carding, vial/syringe inspection or hand assembly. Employees will also be involved with de-inking of product and capsule manufacturing. These individuals must be detail oriented in order to work with multiple look-alike products at the same time.

SPECIFIC DUTIES, ACTIVITIES, AND RESPONSIBILITIES INCLUDED BUT ARE NOT LIMITED TO:\n• Inspect blister cavities for missing product, burnt product, holes in foil, print registration, missing print, crushed blisters and seal integrity.\n• Fill tablet, bottle, desiccant and closure hoppers. Hand count product using counting trays.\n• Manufacturing responsibilities include de-inking product, tablet breaking, product placement into oversized capsules and capsule inspection.\n• Inspect bottles for misalign closures, print registration and missing print copy.\n• Inspect seal integrity of pouch, print registration and missing print copy.\n• Inspect blister units and place them into properly assigned card locations for multi-fill operations.\n• Responsible for cleaning machine equipment and production rooms as stated in cleaning SOP’s. Fill in all appropriate information in the cleaning logbooks.\n• Responsible for cleaning product contact parts.\n• When working on look-alike products you are only allowed to work with your assigned product. Multi-fill projects require that employees do not touch or help out other employees that are assigned different products.\n• Responsible for cleaning production rooms with three bucket sponge mop cleaning system which includes ceilings, walls and floors.\n• All clinical labels must be inspected and require a 100% accountability. Clinical CSD-JD-Packaging Technician v2.0 labels can be either manually or automatically applied.\n• Sealed clinical cards must be inspected for missing copy, poor seal, smudges and dirt, misalign blister units and burnt product.\n• Inspection required for vials, ampoules and syringes utilizing black and white light boxes.\n• Cold storage packaging will also be required working with cold product both outside and inside refrigeration conditions.\n• Assembly work required which may include utilizing barcode scanning equipment and computers.\n• Other duties as assigned.

POSITION REQUIREMENTS:\n• Ability to read and understand customer specifications, cGMP’s and SOP’s.\n• Must be able to follow written and oral instructions in an accurate manner, and effectively communicate.\n• Must be attentive, have a neat appearance and good personal hygiene.\n• Ability to work in a fast-paced environment.\n• Must work well in a team environment.\n• Must be able to work overtime as required.\n• Must be able to troubleshoot problems and report issues.\n• Physically able to perform duties which include cleaning and sanitation of rooms (mopping of walls, floors and ceilings, sanitation of machinery and equipment) and any other tasks as assigned by the supervisor.\n• Must understand and follow all plant safety guidelines.

EDUCATION OR EQUIVALENT:\nHigh School Diploma or equivalent required; 2-3 years previous production or warehouse experience preferred.\n#J-18808-Ljbffr\n","Job Description:

SUMMARY OF ESSENTIAL FUNCTIONS:\nThis position reports directly to the Production Manager. This position must be able to w...","Associate Packaging Technician",["B","2718126510"],"Work at ALLTECH CONSULTING SVC INC","2 days ago","/jobs/2718126510-associate-packaging-technician","/jobs?keyword=ALLTECH+CONSULTING+SVC+INC","/jobs?keyword=Associate+Packaging+Technician","actionData","errors"]