Label Drier Job Description Sample

Overview

The Orchard is a leading independent music, film and video distribution company distributing music from artists such as Ozuna, G Herbo, and Nina Nesbitt as well as acclaimed movies like The Dawn Wall, Bart Layton's American Animals, and Oscar-nominated films Life, Animated and Cartel Land. With cutting edge operations and an unparalleled global team, The Orchard partners with companies of all sizes to make their music, films and videos available across hundreds of digital outlets and physical retailers around the world. At The Orchard, the focus is to provide a comfortable, social and engaging environment to encourage productivity and creativity.

The Orchard is hiring a Manager, Label Management to join our NYC team. Reporting to the Senior Director, Label Management, this position focuses on the development and management of an assigned roster of labels at the industry's leading independent music distributor and label services company. This person should have strong passion, knowledge, and excitement for independent music and label development, an understanding of the current retail landscape and opportunities, experience with metadata best practices, a creative spirit, and solid communication skills

Responsibilities

• Manage day to day relationships with an assigned roster of high profile distributed independent labels

• Collaborate with labels and internal departments to help create and execute release development plans and strategies

• Track pre- and post-release drivers and successes in internal and external priority campaign marketing documents and recaps

• Work across departments to create strategies and campaigns to develop the catalog of assigned label roster

• Manage assigned label's digital and physical product logistics and operations ensuring digital content is delivered in a timely manner and to required specifications using Orchard technology systems, and physical releases make their way to market by way of coordinating with sales, manufacturing, and inventory management

• Liaise with all internal departments (from finance and marketing to legal and management) to ensure labels' business needs are met, as the primary point of contact externally to the label and internally representing your labels' interests

• Utilize The Orchard's internal data and analytics tools to inform marketing and sales decisions

• Ensure the global sales and marketing organization has all assets to properly solicit and market priority releases

• Drive product adoption of The Orchards tools and services across the label base

• Lead in business reviews with assigned priority labels

Qualifications

• Position is customer service and relationship focused, requiring excellent internal and external communication skills and professional diplomacy

• Sales and marketing experience across digital and physical platforms

• Supreme attention to detail, multi-tasking, and follow-through skills required

• Strong knowledge if the music retail landscape and best practices

• Understanding of and experience with artist development

• Strong passion for independent music and label development

The ideal candidate is:

• A self-driven problem solver and leader

• Collaborative with other departments

• Technologically savvy

• A people person with the strong interpersonal skills

• An effective communicator on phone, email, and in person

• Resourceful and takes initiative - an expert troubleshooter

• Passionate about the music business, and the future of music

The Orchard is a leading music distribution company operating in over 40 markets worldwide. With a comprehensive artist & label services offering including full-service marketing, sync licensing, comprehensive video services, transparent data analysis, advertising, rights management, digital and physical distribution and more, The Orchard empowers creators and businesses to grow and adapt in the dynamic global industry. For further information, visit www.theorchard.com.

The Orchard is committed to providing equal employment opportunity for all persons regardless of age, disability, national origin, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, veteran or military status, genetic information or any other status protected by applicable federal, state, or local law.

Job Description:

The Label Coordinator accurately maintains all label and insert inventory and queues all requested work orders for packaging lines 1-8 including all powder filling, boxing, neck banding, etc. Responsible for distributing label and insert inventory to other locations while taking into consideration the company's commitment to our seven Core Values such as Sustainability (people, the planet, and profit) in the planning and implementation of all actions related to the area of responsibility.

• Receive and manually break down all new inventory including labels, IFCs, DSPs, CRDs, inserts, tray-strips, cap-stickers, pouches and foils

• Pull all new and requested samples of labels and inserts for QA label inspectors and specialty departments

• Accurately tag and transfer all label and insert inventory

• Issue all appropriate labels and inserts on all requested work orders for packaging lines

• Ensure that proper revisions of requested materials are used and other technical notes are up to date

• Print all necessary tags required to complete each job

• Ensure all work orders are completed with proper record of all used inventory including, but not limited to, label audit verification and box audit

• Rewind, count and record all return label and insert information

• Ensure all label and insert inventory is maintained and organized

• Initiate paperwork for all QT and destroyed labels and inserts

• Follow and adhere to all given instructions including work procedures, Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP)

• Strictly adhere to and observe all safety policies as outlined in the company policies and training sessions

• Other duties as assigned

Requirements

Technical

• Ability to multitask while prioritizing job requests

• Accuracy with numbers

• Organized along with good bookkeeping and inventory skills

• Able to understand and carry out all written and verbal instruction along with good communication skills

• Knowledge of regulations and procedures of production lines and products

• Some basic computer skills

Attributes

• Ability to work in a team environment is essential

• Ability to work effectively to meet deadlines

• Positive attitude; adaptable to change

• Physically capable to perform all job duties

• Respect for authority and company policy

Company Overview

Natural Factors Nutritional Products Ltd. is a leading manufacturer of nutritional supplements and other health-building products. We are dedicated to enhancing the wellbeing of our customers - through research, development and delivery of effective nutritional products. It is our mission to contribute to the lives of our customers, employees, suppliers and the communities we serve, in a cooperative and sustainable manner.

Posting Details

This position is open to all qualified applicants who are legally entitled to work in the country in which this job is located. Only electronic applications can be accepted. This position will close when a competitive candidate pool has been identified. We thank you all for your applications; however, only those selected for an interview will be contacted. You can check the status of your application by logging in to your account. All the best!

Overview

The Orchard is a leading independent music, film and video distribution company distributing music from artists such as Ozuna, G Herbo, and Nina Nesbitt as well as acclaimed movies like The Dawn Wall, Bart Layton's American Animals, and Oscar-nominated films Life, Animated and Cartel Land. With cutting edge operations and an unparalleled global team, The Orchard partners with companies of all sizes to make their music, films and videos available across hundreds of digital outlets and physical retailers around the world. At The Orchard, the focus is to provide a comfortable, social and engaging environment to encourage productivity and creativity.

The Orchard is hiring a Manager, Label Management to join our NYC team. Reporting to the Senior Director, Label Management, this position focuses on the development and management of an assigned roster of labels at the industry's leading independent music distributor and label services company. This person should have strong passion, knowledge, and excitement for independent music and label development, an understanding of the current retail landscape and opportunities, experience with metadata best practices, a creative spirit, and solid communication skills

Responsibilities

• Manage day to day relationships with an assigned roster of high profile distributed independent labels

• Collaborate with labels and internal departments to help create and execute release development plans and strategies

• Track pre- and post-release drivers and successes in internal and external priority campaign marketing documents and recaps

• Work across departments to create strategies and campaigns to develop the catalog of assigned label roster

• Manage assigned label's digital and physical product logistics and operations ensuring digital content is delivered in a timely manner and to required specifications using Orchard technology systems, and physical releases make their way to market by way of coordinating with sales, manufacturing, and inventory management

• Liaise with all internal departments (from finance and marketing to legal and management) to ensure labels' business needs are met, as the primary point of contact externally to the label and internally representing your labels' interests

• Utilize The Orchard's internal data and analytics tools to inform marketing and sales decisions

• Ensure the global sales and marketing organization has all assets to properly solicit and market priority releases

• Drive product adoption of The Orchards tools and services across the label base

• Lead in business reviews with assigned priority labels

Qualifications

• Position is customer service and relationship focused, requiring excellent internal and external communication skills and professional diplomacy

• Sales and marketing experience across digital and physical platforms

• Supreme attention to detail, multi-tasking, and follow-through skills required

• Strong knowledge if the music retail landscape and best practices

• Understanding of and experience with artist development

• Strong passion for independent music and label development

The ideal candidate is:

• A self-driven problem solver and leader

• Collaborative with other departments

• Technologically savvy

• A people person with the strong interpersonal skills

• An effective communicator on phone, email, and in person

• Resourceful and takes initiative - an expert troubleshooter

• Passionate about the music business, and the future of music

The Orchard is a leading music distribution company operating in over 40 markets worldwide. With a comprehensive artist & label services offering including full-service marketing, sync licensing, comprehensive video services, transparent data analysis, advertising, rights management, digital and physical distribution and more, The Orchard empowers creators and businesses to grow and adapt in the dynamic global industry. For further information, visit www.theorchard.com.

The Orchard is committed to providing equal employment opportunity for all persons regardless of age, disability, national origin, race, color, religion, sex, sexual orientation, g

Date: Feb 9, 2019

Location:Morrisville, NC, US

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 211

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

Global Functions – The Corporate division is the central operating unit of the company; setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. The global Company headquarters is located just outside of Philadelphia in Wayne, PA. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.

Position Summary

Work in coordination with cross-functional management as well as Project Steering Committee, core team, and stakeholders to achieve overall Labeling Legal Manufacturer Address Change project goals and objectives. Coordinate planning and implementation activities with Manufacturing, Demand Planning, Logistics and Distribution, and International Registrations and Business Unit representatives. Experienced with project management tools and processes and can manage critical situations and provide professional communication of project status to senior management as well as all team members.

Principal Responsibilities

• Define the objectives, requirements, and assumptions necessary to structure a project or activity.

• Plan, schedule, and control activities to fulfill identified objectives applying technical, theoretical, and managerial skills to satisfy project requirements.

• Drive and develop integrated development plan that represents the appropriate level of detail and task interdependency and aligns project tactics with overall project strategy.

• Establish and maintain a high performing team and serve as a project advocate within the organization.

• Lead (coordinate, facilitate, and motivate) the efforts of the individual, team, customer, and other resources associated with Labeling project activities. Acquire alignment in task deliverables and goals.

• Manage the project within the established scope, schedule, and budget while maintaining quality as a top priority.

• Lead risk management within the project team. Ensure risks have appropriate mitigation and develop contingency plans.

• Present to executive leadership, steering committee members, senior management, and department SMEs weekly and monthly project status and escalate risks as necessary.

• Facility weekly meetings, take meeting minutes with action items, and follow up with SMEs on expected deliverables.

• Maintain strong documentation of project plans, schedules, tracking metrics, and status reports.

Education / Experience Requirements

• Bachelor's degree in a business discipline or equivalent education/experience required.

• Minimum 1+ years experience in the medical device and/or FDA regulated industry.

• Minimum 5 years project management experience in large organizations with national or global operations.

• Knowledge and application of a disciplined project management process.

• Six Sigma PMP or similar project management certification preferred.

Specialized Skills / Other Requirements

• Strong skills in Project Management tools (e.g. Microsoft Project).

• Exceptional skills with MS Outlook, SharePoint, Excel, and Power Point presentation.

• Experience with Agile and SAP preferred.

• Exceptional interpersonal and leadership skills. Capability to utilize these skills with a broad spectrum of audiences, ranging from front-line workers to senior level executives.

• Technical aptitude and displayed ability to grasp a general knowledge of multiple disciplines and technologies.

• Strong competencies in strategic planning, project management, leadership, and organizational skills.

• Ability to produce and present clear, concise, and professionally written communications and presentations.

• Strong analytical capabilities and business acumen.

• Ability to grasp strategic concepts and strategy development skills.

• Ability to lead and facilitate multiple activities and resources.

• Demonstrated work ethic, integrity, and professional conduct.

• Superior computer usage skills.

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

Division: Global Services

Business Unit: Supply Chain Management

Requisition Number: 238051

Primary Location: United States-Georgia-Norcross

Assignment Category: Full-time regular

Experience Level: Mid level

Education Required Level: Bachelor's Degree

Travel Required: 25%

Division Description:

Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationally for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in seven Divisions: Power and Gas, Power Generation Services, Energy Management, Building Technologies, Digital Factory, Process Industries and Drives, and Financial Services.

Our support functions are split into two organizations, Corporate Core and Corporate Services. These organizations provide essential services to better enable responsible and profitable growth.

For more information,please visit: http://www.siemens.com/us/en/home/company/about/businesses.html

Job Description:

Position Overview

The Procurement Specialist, Brand Label Products and Systems is assigned to the EM LP (Energy Management Low Voltage Products) Business in USA/Canada/Mexico unit drives the development and implementation of a procurement strategy for the area of Brand Label Products and Systems Business. You will proactively interact with EM LP Product Management to ensure alignment with Business Requirements, Early Procurement and Supplier Involvement and achieving financial and non-financial targets by application of all relevant procurement levers.

The position reports functionally to the Brand Labeling Mgr. of Procurement for the EM LP Business unit for US/CAN/Mexico.

Responsibilities

You will successfully manage the assigned purchasing volume in the area of Brand Label Products and Systems Business. Area of responsibility has significant impact on the overall success of the Business Unit (BU) Product Lifecycle Management strategy, operational performance and cost reduction targets:

• Participates in the PLM (Product Lifecycle Management) process and integrates supplier and supply market expertise prior to decisions on product portfolio.

• Implements/Supports material strategy for major commodities/Brand Label business that aligns strategically with BU EM LP.

• Implements/Supports Buy-Siemens initiatives for Systems Procurement.

• Creates transparency on the supplier market, introduces and drives qualification of new suppliers; benchmarks existing supplier base.

• Achieves cost reduction targets under consideration of delivery reliability, quality aspects and total cost of ownership.

• Ensures compliance of procurement process through early involvement in Brand Label Strategy and Systems sales and order management activities.

• Focuses on Contribution-to-Growth (CTG) KPI for System Business.

Required Knowledge/Skills, Education, and Experience

Bachelor's Degree in Engineering, Business Administration or Supply Chain required.

Five plus years of strong experience working in some aspect of Supplier Management, Product Management, Sales or Product Development preferably relative to a factory environment.
20% to 25% travel to North American Operational sites and supplier facilities in various regions of the world.

Skills:

• Demonstrated procurement skills in the areas of Supplier Management, Contract Negotiations, Supply chain Processes, Sourcing, Product Lifecycle Management and system integration.

• Strong written and verbal Communication skills including extensive expertise in presentation development and delivery. Comfortable working with higher levels of management within an organization.

• Demonstrates and applies advanced knowledge of concepts, practices, and procedures for area managed and expert knowledge of other areas in the company and how they interact.

• Understanding and application of functional management approaches and leading and acting in cross-functional teams. Team player.

Preferred Knowledge/Skills, Education, and Experience:

• International business experience is an advantage

• Sales, System Integration R&D or Product Management

• Commercial Procurement Expertise is a plus

#LI-JT1

For the team at Caito Foods, the produce business is straightforward. It's about buying the best products available and being devoted to freshness.

Working together, our goal is to make our customers' jobs easier by ensuring that the freshest and most on-trend products make it to kitchens nationwide. Our outstanding team fulfills that promise every day.

Position Summary

Responsible to lead and assist with the preparation, cooking, packaging and/or assembling of food products for sale to the company's retail stores, distribution center(s) and/or third party customers. Assist to ensure adherence to recipes, quality standards, production expectations and sanitation regulations.

Minimum Requirements

Degrees

High School Diploma (Required)

or GED.

Job Experience

. Experience in food service (i.e. restaurant, deli, etc.) or food production required.

ServSafe food safety certification required or obtained within one year.

Responsibilities and Essential Duties

Lead and assist with the preparation, cooking, packaging and/or assembling of food products to include hot foods and cold deli foods.

Assist with monitoring and ensuring adherence to recipes, quality standards, production expectations and sanitation regulations (i.e., temperature audits, hand washing, wearing prep gloves, food in cooler properly labeled, etc.). Provide training and guidance to ensure company's standard operating procedures are followed.

Use equipment and utensils to properly prepare, assemble and package hot foods and deli products, to include cutting fruits and vegetables and cooking food to be used in the assembly of deli products, according to specifications to consistently create quality products.

Weigh, package, wrap and/or bag, and label products.

Maintain a clean and sanitized facility to include the food preparation area and washing dishes.

The above statements are intended to describe the general nature and levels of work being performed as assigned for this job. This is not intended to be an exhaustive list of all responsibilities, duties and requirements; additional responsibilities may be assigned as needed.

Knowledge, Skills Abilities

Must be able to provide training and guidance on day-to-day production activities. Ability to follow written (recipes) or verbal instruction in adherence to food preparation specifications.

Ability to read weight/label scale (numbers). Must be able to use cooking utensils and equipment (i.e., knives, stoves, etc.) to prepare food products. Ability to work in a fast paced food production environment. Knowledge of sanitation and food handling procedures required.

Physical Requirement

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

May be required to lift and/or move up to 30 pounds frequently, and up to 50 pounds occasionally. The associate is frequently required to sit/stand/walk. May be required to travel.

While performing the duties of this position, the employee is subject to a typical food production environment (varied temperatures; frequent refrigerated/cold environment) and is rarely exposed to outside weather conditions. The employee will be exposed to refrigerated/freezer coolers on a frequent basis. The noise level in the work environment is usually low to moderate.

Equipment

General Kitchen/Deli equipment (i.e. slicers, fryers, scales, ovens, mixers, steamers, etc.)

Other Retail Equipment (e.g., pallet jacks, cardboard baler, sanitation and cleaning supplies, etc.)

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Picks up cartons from one pallet and place on another pallet based on customer specifications

• Check cartons for quality

Required Skills

QUALIFICATION REQUIREMENTS:

To perform this job successfully, an individual must have excellent attendance, be able to work independently and be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

LANGUAGE SKILLS:

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.

MATHEMATICAL SKILLS:

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

REASONING ABILITY:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Required Experience

EDUCATION and/or EXPERIENCE:

High school diploma or general education degree (GED)

We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We're named after Atara Ciechanover who suffered from cancer before passing away. We are considered a leading off-the-shelf T-cell immunotherapy company (Nasdaq ATRA) developing novel treatments for patients with cancer, autoimmune and viral diseases.

Position Summary:

This role assists in the design, implementation, and execution of the strategy and process to ensure compliance to Good Manufacturing and Good Distribution Practices for all Atara's clinical and commercial finished goods (final packaged product). This includes the support of packaging and labeling technical transfer activities, and process improvements both internal and external to Atara. This position interacts cross-functionally with with all areas of Quality, Supply Chain, and Regulatory Affairs.

Reports to: Director, Quality Operations

Location: Thousand Oaks, CA

Primary Responsibilities:

• Performing Batch Review and Release of finished clinical and commercial product.

• Partnering with Regulatory Affairs and Supply Chain to implement label generation and control procedures

• Provides support and potential oversight for Packaging and Labeling CMOs and management of Quality Assurance activities of external packaging partners

• Partnering with Supply Chain and Clinical Operations to meet clinical and commercial release targets

• Leads Quality system record (e.g., Deviations, CAPA, change control) execution and oversight

• Partnering with the Qualified Person on Batch package review

• Partnering with Regulatory Affairs to ensure compliance with filed labelling requirements

• Providing routine Quality Assurance & Compliance support, and assess the upcoming regulations impacting the compliance activities of Packaging and Labeling activities

• Evaluate and assure that the new or revised technical process and systems that includes the product packaging & distribution are compliant with the current regulations & meeting the product specifications

• Collaborating with QA colleagues to ensure integration of GMP batch disposition requirements with other QMS at Atara and CMOs

• Supporting IND, CTA preparation and Audit readiness initiatives

• Support the development of track and trace and product serialization programs to comply with Drug Quality and Security Act and Drug Supply Chain Security Act

• Work with Supply Chain to devise and implement anticounterfeiting and anti-diversion procedures.

• Support the selection and assessment of container closure systems and their specifications

• Escalating issues identified to Atara and CMO leadership as applicable

• Drafting and approving related controlled documents such as SOPs, Work Instructions, and Forms

• Optimizing the Atara batch package and disposition process and workflow

• Interfacing with inter-departmental stakeholders (e.g., Validation, Engineering, Facilities, Manufacturing, Regulatory Affairs, and Quality Control) to ensure achievement of Atara's goals, including compliance with applicable standards

• Driving continuous improvements in the areas of labeling, packaging, distribution and supply chain management

Skills and Abilities:

• Demonstrate ability to work in a team environment to develop, implement and deliver on goals

• Demonstrate ability to work successfully and with appropriate sense of urgency in a nimble fast paced matrixed environment

• Ability to work both independently without supervision and be a part of a team, demonstrating excellent communication and interpersonal skills

• Strong problem solving and analytical skills with demonstrated ability to be detail oriented; while managing multiple projects simultaneously

• Must be a strong team player and ability to collaborate cross functionally

• High bar personal ethics with a "patients first" value system.

Education and Professional Experience:

• Bachelor's Degree in engineering or Life Sciences

• 7 or more years of experience in a GMP regulated Biologics or Pharmaceutical environment

• Experience in a commercial phase pharmaceutical environment

• Experience with Contract Manufacturing Organizations

• Direct experience participating and supporting regulatory inspections and submissions

• Advanced knowledge of relevant regulations and regulatory guidance required to act as a resource for colleagues

• Root Cause Analysis Training

• Ability to effectively plan, organize work activities and prioritize task completion to meet deadlines

• Experience in 21 CFR 210/211, 1271, 2001/83/EC, 2006/17/EC and 2006/86/EC

• Ability to gown and gain entry to manufacturing areas

• Flexibility in working schedule, i.e., off hours, second shift, weekend

Physical Requirements:

Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in a manufacturing and office environment, with some warehouse environment work.

Travel: Some travel is required (25%)

More About Atara Bio:

Now in our sixth year, we're proud of our team of 260+ Atarians co-located by design in South San Francisco (corporate headquarters) and Southern California (R&D and manufacturing headquarters in the northwest Los Angeles area) with a newly-established European headquarters in Zug, Switzerland. Atara also has a R&D site in the Denver, Colorado area and an office in New York City. Our Southern California hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California.

One mission – "Transform the lives of patients with serious medical conditions through pioneering science, teamwork and expertise" – and a singular vision – "Cell therapy treatment for every patient, any time – provide inspiration and direction for all of us."

The Company's off-the-shelf, allogeneic T-cells are bioengineered from donors with healthy immune function and allow for rapid delivery from inventory to patients without a requirement for pretreatment. Atara's T-cell immunotherapies are designed to precisely recognize and eliminate cancerous or diseased cells without affecting normal, healthy cells.

Atara's most advanced T-cell immunotherapy in development, tabelecleucel, or tab-cel™ (formerly known as ATA129), is being developed for the treatment of patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). Tab-cel™ is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study).

Atara is also developing off-the-shelf, allogeneic ATA188 and autologous ATA190 T-cell immunotherapies using a complementary targeted antigen recognition technology for specific EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS). A Phase 1 clinical study of autologous ATA190 in patients with progressive MS is ongoing. Atara is also advancing a Phase 1 clinical study of ATA188 in patients with progressive or relapsing-remitting MS across clinical sites in the United States and Australia. Atara's clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV).

Working at Atara Bio:

People at Atara Bio are high integrity, roll-up-your-sleeves, get-it-done types who are keenly committed to putting patients first, advancing medical care and doing so with demonstrated urgency. At their core Atarians are people who work well with others and are "team-centric", have purposeful curiosity and can't wait to save patient lives. And similar to other biotech companies who have so many accomplished people, we expect humility (we are a "low hubris" sort of place), flexibility, respect, teamwork, good judgment and getting the most out of any dollar we spend. We also expect to enjoy the journey (and each other) as we move forward with a shared responsibility to teach and to learn from what we do and from our teammates.

Atara Bio is an equal opportunity employer and makes employment decisions on the basis of merit and other lawful factors. In accordance with applicable law, the Company prohibits discrimination based on race, color, religion, creed, sex, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity, expression or dysphoria, marital status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, veteran status, caregiver status, sexual orientation, transgender status or any other classification protected by federal, state or local laws or because of the individual's association with a member of a protected group or connection to an organization or group related to a protected group.

We comply with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Atara Bio in the United States.

Manager/Senior Manager Label Development

Full-time

Job Location:

Emeryville, CA

Department:

Supply Chain and Logistics

Reports to:

Head, Clinical Supply Chain, USA

Education Required:

B.S. in scientific or technical discipline or equivalent
8-11 years of experience in biotech/pharmaceutical, device or diagnostic industry, including at least 4 years of Regulatory Affairs or equivalent experience

Demonstrated experience developing strategy for product labeling

Knowledge of primary and secondary packaging used for small molecule and biologic products (including devices)

Experience with material planning, device assembly and process validation is a plus

General Description:

• Manage end-to-end clinical labeling activities including label design, translation and production, working collaboratively with internal and external partners.

• Create and manage change control of labeling artwork for medical products and ensure its contents meet all medical,legal, and regulatory requirements.

• Review, edit and proofread labeling artwork, plate proofs and samples to ensure content, quality and format comply with product specifications and that the label is technically capable of being printed and used on intended packaging equipment and components (i.e. vial, bottle, syringe, etc.)

• Write and review departmental SOPs and ensure updates and compliance with industrial standards.

• Continually monitor and evaluate the current regulatory environment in order to provide guidance and develop regulatory strategy for labeling content development with internal and external stakeholders.

• Serve (as required) as senior contact for CMOs, labeling vendors/printers to resolve issues related to labeling under development, revision or reorder.

• Introduce, evaluate and implement improvements to the labeling process, systems, and policies

• Lead or support vendor and software (i.e. printers, translators, proofing, etc.) evaluation and selection

• Present regulatory labeling strategies and issues to corporate committees and senior management as required.

• Develop and deliver training material to internal personnel on the pertinent regulations relative to product labeling.

• Lead, manage, or support product labeling development, maintenance and revisions for BeiGene's marketed pharmaceutical products and devices.

• Ensure that content, quality, accuracy and format of labeling components of FDA submissions comply with applicable laws, regulations and corporate policies.

• Contribute to development of a database of interactions with regulatory authorities, which will support the group's strategic activities.

• Develop strong internal collaboration with stakeholders, such as Clinical Operations, Regulatory Affairs, Quality, and Manufacturing functions to ensure high customer satisfaction.

• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.

Computer Skills:

• Efficient in Microsoft Word, Excel, PowerPoint and Outlook.

• Experience with an ERP system desired (SAP preferred).

• Proficiency in a graphic program like Adobe Illustrator or Adobe InDesign preferred

Other Qualifications:

• Due to the global nature of the company early morning or evening meetings are required.

• Strong understanding of FDA and other country Health Authority regulations and guidelines with the ability to interpret and apply them strategically

• Initial scope will be clinical, but this may expand to include marketed products too, so having experience with labeling requirements for commercial products is a plus

Supervisory Responsibilities:

Currently this role does not have direct reports, but a successful candidate needs to be able to demonstrate the ability to lead/direct a cross-functional team and influence without direct authority. This role may broaden to include people management responsibilities and this person would be expected to build that team.

Travel: 10%, domestic and international