Planet Pharma Jobs in Usa

JOB DESCRIPTION

The Research and Development Operator I would operate, clean, disassemble, and reassemble equipment such as blending, granulation, compression, and coating machinery in accordance with applicable cGMP and SOPs. In this role, the incumbent would rotate between Pilot Plant and Manufacturing departments as determined by the needs of the business.

Essential Duties & Responsibilities

• Proficiently operate, disassemble, assemble, and clean equipment.
• Operate, disassemble, assemble, and clean equipment in other departments proficiently.
• Routinely perform housekeeping assignments, maintain cleanliness and routine maintenance of the work area and equipment.
• Uses computer to read, review, and train on SOPs.
• Review current SOPs and provide feedback on potential process improvements.
• Participate in work scheduling. Handle computer transactions/metrics for the department.
• Record operating data within batch records in accordance with cGDP.
• Review and record completed production documentation (batch records, logbooks, etc.) for quality and cGMP compliance.
• Able to troubleshoot production processes and notify applicable parties for assistance.
• Recognize and report manufacturing incidents. Support investigations and support CAPA’s on occasions.
• Builds productive, trusting, and respectful relationships at all levels in the organization and must consistently act as a team player.
• Collaborate effectively and communicate with other functional groups, including quality, validation, and supply chain to ensure production goals are achieved.
• Follows Piramal Pharma Solutions Safety, Health, and Environmental policies and procedures.
• Maintain confidentiality for all clients and activities in the development process.
• Performs other duties as assigned or as business needs require.

Requirements

• High school diploma or GED required.
• Individuals with equivalent education, training, and experience will be considered.
• Experience in a pharmaceutical, chemical, biochemical, or food manufacturing environment required.
• 2+ years working within an industrial or manufacturing environment preferred.

Physical Requirements

• Lift up to 40 lbs. and occasionally move drums weighing up to 300 lbs.
• Able to work safely with heavy equipment.
• Regularly stand, walk, sit, use hands to finger, feel objects, tools, controls, reach with hand and arms, talk, hear, and good vision.
• Ability to climb ladders, bend, stoop, and kneel.
• Individual may be required to wear Personal Protection Equipment including N95 respirators and Powered Air Purifying Respirators.
• Not allergic to chemicals or bio-substances found in laboratory or production facilities.

SAP Product Cost Manager, 170k plus bonus, Princeton, International Pharma Company

US CITIZEN OR GREEN CARD ONLY

US CITIZEN OR GREEN CARD ONLY

HYBRID MODEL, 3 DAYS ON SITE

NO REMOTE WORK

MUST HAVE BEEN THROUGH 3 TO 4 FULL LIFECYCLE SAP IMPLEMENTATIONS

• Own the implementation, design, configuration, and continuous enhancement of SAP S/4HANA Product Costing (CO-PC) including standard cost planning, Material Ledger, cost component split, variance analysis, Margin Analysis (CO-PA), and Cost Center Accounting.
• Implement and manage cost center planning, activity type planning, overhead costing sheets, template allocations, and cost assessments/distributions. Support budgeting cycles and financial forecasts integrated with SAP S/4HANA.
• Manage and govern seamless integration between Controlling and related modules such as Financial Accounting (FI), Production Planning (PP), Materials Management (MM), and Sales & Distribution (SD) to ensure seamless data integration, process alignment and accurate cost flows.
• Oversee and support day-to-day, month-end and year-end processes, which include cost allocations, assessments, project settlements, revaluation, and variance analysis, to ensure accurate and timely financial reporting. Additionally, manage the costing processes, such as cost rollups, inventory valuation, cost estimates, and revaluation of consumption. Ensure the accuracy of the Material Ledger and actual cost flows across multiple plants, company codes, and currencies. 20%
• Act as the SME and escalation point for CO-PC, CO-PA and other CO related incidents. Identify gaps and opportunities for process standardization and automation within SAP CO-PC. Lead process improvements to enhance efficiency, accuracy, and scalability. Perform root cause analysis, recommend corrective actions, and develop functional specifications for RICEFW objects, perform unit/integration/UAT testing and coordinate with developers for RICEF object resolution (Reports, Interfaces, Conversions, Enhancements, Forms).
• Conduct FIT/GAP analysis, develop functional specifications for RICEFW objects, perform unit/integration/UAT testing, and support cutover and go-live activities. Provide ongoing support for system stabilization and continuous improvement initiatives.
• Collaborate with finance, operations, and IT stakeholders to translate business needs into technical solutions. Actively contribute to SAP S/4HANA transformation projects, S/4HANA roadmaps, upgrades, and process improvement initiatives with focus on CO and Product Costing streams.
• Incumbent must follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.

Knowledge, Skills and Abilities (KSA)

• Exceptional problem-solving, communication, and business engagement skills.
• Excellent communication and presentation skills
• Ability to work on projects with cross functional teams, external resources, and PMO.
• Manage business users independently, be self-motivated, proactive and a team member.
• Ability to embrace new technologies and adopt to an evolving environment.
• Ability to adopt flexible schedule to meet multiple time-zones for meetings with peers and stakeholders.

Qualifications/ Background Experiences

• Bachelor’s degree in Finance, Accounting, or equivalent experience.
• Minimum 10 years of SAP experience with deep focus on Product Costing (CO-PC) and Profitability Analysis (CO-PA).
• Demonstrated experience working in complex, global SAP S/4HANA environments.
• In-depth knowledge of SAP CO modules (CO-PC, CO-PA, PS, CCA) and integration with FI/MM/PP.
• Deep understanding of cost flows, costing variants, overhead calculations, and inventory valuation.

POSITION SUMMARY:

The Instrumentation and Calibration Engineer has the responsibility for ensuring the site’s production instruments are operating at optimal levels and properly maintained to data collection in an FDA regulated environment. The position will be primarily responsible for ensuring all instruments are maintained in a calibrated state. Additionally, the Engineer will support general troubleshooting of production equipment/utilities, and asset management.

To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required:

• Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
• Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values.
• Identify and protect the original technical information as part of the company property.

KEY RESPONSIBILITIES.

• Support the Preventive Maintenance (PM) program through the creation of new PM tasks, evaluation of existing PMs for technical relevance to current asset problems.
• Help create Standard Operating Procedures (SOPs) for equipment operation, engineering analyses, PM and calibration tasks, that adhere to FDA and cGMP requirements.
• Support the management of the calibrations on production instruments, such as temperature sensors (RTDs/resistance thermometers), pressure sensors (electronic manometers, gauges), and other transmitters.
• Support root cause investigations to a detailed level required for an FDA regulated/cGMP environment, and translate these root causes to effective CAPAs that mitigate equipment risk.
• Assesses and monitors equipment for reliability of operation implementing necessary improvements
• Maintains system classification of incoming equipment with the system owner. Duties may include assembly of supplier operating and maintenance manuals, installation and operational qualification.
• Translate data from Root Cause Centered Maintenance (RCCM) data to support Autonomous Maintenance program. Train Operations personnel in Autonomous Maintenance.
• Maintain calibration records, and qualification of calibration contractor.
• Manages risk to achieve organization's strategic objectives in areas of environmental health and safety, asset capability, quality, and production.
• Conducts risk analyses routinely when production equipment is functioning outside of expected parameters
• Develops Total Cost of Ownership, Mean Time to Failure, Life Cycle Cost, Mean Time to Repair, specific to critical equipment in the production areas.
• Runs process improvement projects from design thru implementation. Apply Root Cause Centered Maintenance (RCCM) to develop improved preventive maintenance tasks.
• Executes changes through to completion, from initiation of change controls to revising SWIs, coordinating work with Maintenance/Engineering, etc., to close out of CCs
• Collaborates with other departments to ensure that reliability is integrated into all aspects of the organization
• Participates in and execute qualification and validation of equipment and processes

EDUCATION/EXPERIENCE.

• Bachelor’s degree in an engineering discipline and 3 years of experience in a related or similar field, or
• Associate’s degree in an engineering or scientific discipline and at least 5 years of experience.

JOB COMPETENCIES.

• Analytical thinking: the ability to think critically and logically, as well as the ability to work with large sets of data and make sense of them.
• Technical aptitude: a strong understanding of the systems, equipment, and processes at hand. This includes knowledge of the engineering principles and specific systems used at an organization.
• Mechanical aptitude: an understanding of how mechanical components fit together and support the function of equipment. Demonstrated curiosity for how production equipment functions.
• Problem-solving: the ability to think creatively and come up with innovative solutions to complex problems. Specific experience applying Root Cause Analysis and Root Cause Investigation concepts to determine root causes and create effective corrective actions.
• Communication: the ability to explain technical concepts in a clear and understandable manner, as well as the ability to collaborate effectively with others. The ability to generate highly technical equipment maintenance into work instructions for Maintenance Technicians.
• Time management: the ability to manage multiple projects and tasks simultaneously and effectively including planning, scheduling, and organizing. Preferred experience in the Agile Project Management System.
• A continuous improvement mindset: identifying and implementing ways to continuously improve reliability.
• An understanding of lean manufacturing principles, and applying Six Sigma concepts to chemical manufacturing.
• Safety-conscious: the ability to identify potential hazards and take the necessary steps to mitigate them.
• Knowledge of CMMS system and functions
• Knowledge of the regulations and their application to instruments that gather GMP data in a production environment.

JOB OVERVIEW:

The Validation Scientist position encompasses all areas of Technical Services with primary focus on technology transfer, scale-up, process optimization, process/packaging validation, commercial production technical support as well as equipment qualification and cleaning validation support.

KEY ROLES/RESPONSIBILITIES:

• Lead and execute projects such as technology transfer, scale-up, process optimization process/packaging validation as well as equipment qualification and cleaning validation support to meet critical project deadlines.
• Provide technical support in the investigation of manufacturing incidents and major deviations. Assure thoroughness of investigation and documentation as well as implementation of preventive/corrective actions as necessary.
• Conduct commercial production technical support activities such as qualification of alternate suppliers of API, excipients and packaging components, equipment change parts, process parameters, yield limits, hold time studies, etc.
• Execute utility and process equipment qualification support activities such as installation, operational and performance qualifications, periodic reviews, investigations, assessments, review change control and non-routine maintenance requests, out of specification calibrations, etc.
• Perform cleaning validation support activities such as execution of cleaning validation and verification studies, hold time studies, investigations, assessments, justifications, maintain cross contamination program, etc.
• Develop and/or execute experimental designs and approaches to resolve technical problems and utilize engineering standards, principles, concepts, equations as well as statistical techniques.
• Prepare and review documents to support projects, such as laboratory notebooks, protocols, reports, assessments, justifications, investigation reports, regulatory submissions, master batch records, change control, etc.
• Complete and document physical sampling and testing such as loss on drying, particle size distribution, bulk density, viscosity, pH, tablet weight, thickness, hardness and friability; sample for analytical and microbiological testing.
• Author and periodically update assigned Standard Operating Procedures (SOPs) for the department.
• Represent Technical Services at project team meetings and provide sound technical advice.
• Coordinate and interface with Operations, Facility Engineering, Quality Control, Quality Assurance and Regulatory Affairs groups to assure successful project execution.
• Directly interact with Piramal Pharma Solutions clients.
• Maintain regulatory compliance within the function and follow site safety, health, and environmental policies and procedures.

EXPERIENCE:

• Minimum of a Bachelor's degree in a scientific discipline (e.g., Chemical Engineering, Pharmaceutics, Pharmacy, Chemistry or equivalent) with a minimum of 3 years experience in Technical Services, Process Engineering, Process Validation, Formulation or related field in the pharmaceutical industry.
• Experience in laboratory and production scale manufacture of solid oral, liquid and semi-solid dosage forms using equipment such as comminuting mills, high-shear granulators, fluid bed dryers, blenders, tablet presses, tablet film coaters, encapsulates, low and high-shear mixing vessels, homogenizers, pumps, packaging, etc.
• Working knowledge of cGMP (Current Good Manufacturing Practices) regulations, SUPAC guidance, and general compliance expectations.
• Working knowledge of investigational techniques, including but not limited to root cause analysis, risk assessment impact evaluation, and technical report writing.
• Must possess research and problem solving abilities and be capable of producing detailed documentation, understand and make generalized and specific conclusions from project data.
• Technical writing experience is required with attention to detail skills essential.
• Must be able to work in a team environment with effective project planning/management, analytical thinking, organization, and execution skills.
• Must have proficiency in the Microsoft Office Suite programs.
• Demonstrated professionalism and excellent communication skills with internal and external personnel are essential.
• Ability to work effectively managing multi projects at a fast pace withcross-functional departments and manage priorities to meet timelines.
• Must be innovative, proactive, resourceful and committed to continuous improvement.
• Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP) is preferred.

WORK ENVIRONMENT:

The position requires the ability to work in ahigh demand office and manufacturing setting with time spent performing "on the floor" activities in laboratory and manufacturing areas. The position may require extended hours including evenings and weekends as well as work hours on 2nd and 3rd shifts depending on project needs.

NO 3RD PARTIES – CLIENT NOT PROVIDING VISA SPONSORSHIP

The Planet Group is seeking a Workday HCM Administrator for a hybrid onsite role in Richmond, VA. This is a fulltime permanent position - this is NOT a contract.

Richmond, VA – hybrid 3 days/week in the office - 100% remote is NOT an option – WILL ONLY CONSIDER LOCAL CANDIDATES.

Salary: $125,000 - $135,000

The client is going to be implementing Workday and is looking for someone who already has previous Workday experience in Core HCM, Recruiting, Advanced Compensation, Talent, and Absence Management preferred.

•Serve as the subject matter expert supporting Human Resources applications, particularly Workday, across the full lifecycle: design, build, and run.

•Will be doing implementation work, helping lead consultants and contractors, help with best practices, and do some work on the backend.

•Will partner closely with HR, Payroll, and IT teams to strengthen core systems, improve processes, and ensure a reliable, intuitive experience for employees and leaders.

•Will also oversee day to day service delivery for Workday, including incident management and vendor performance, ensuring issues are handled thoughtfully, escalated appropriately, and aligned with Indivior policies and SOPs.

Shape the HR applications roadmap

•Contribute to the IT and Business Applications roadmap, aligning technology improvements with business needs

•Participate as a key contributor on system enhancements and projects from concept through implementation

•Partner with HR and IT teams to assess, prioritize, and deliver continuous improvement initiatives

Deliver reliable Workday support

•Oversee the team managing incidents and service requests for Workday

•Ensure system operations meet business needs while adhering to Indivior policies and SOPs

•Review incident metrics to identify trends and improvement opportunities

Support administration, payroll, and controls

•Provide HR application administration and process updates

•Support payroll processes across Workday and ADP

•Execute IT and Sarbanes Oxley (SOX) controls

•Build and maintain the Workday intranet page with clear, engaging content

•Support Workday release management activities

Lead application and vendor management

•Provide subject matter expertise across design, build, and run phases

•Act as the primary contact for outsourced application support vendors

•Ensure service levels are met and issues are escalated appropriately

Strengthen governance and documentation

•Mature IT documentation for clarity, consistency, and compliance

•Review and approve IT governance and procedure documentation

Requires:

•Bachelor’s degree in Human Resources, Business, or Information Technology

•Industry experience in Pharmaceuticals or Life Sciences

•Experience with Windows, MS Office, Workday, ServiceNow, and SuccessFactors

•5+ years of application management experience with strong HR systems exposure

•Working knowledge of Workday modules including Core HCM, Recruiting, Advanced Compensation, Talent, and Absence Management preferred – this is a MUST

•3+ years coordinating outsourced application support providers

•Experience with governance, business process improvement, system design, documentation, and testing

•Experience supporting end users and creating training materials

•Customer and results oriented mindset

•Strong communication and collaboration skills

•Effective problem solving and diagnostic abilities

•Flexible, pragmatic approach to work

At The Planet Group, we connect Enterprise Systems experts with opportunities that match their skills, goals, and ambition. From fast-moving startups to global enterprises, we partner with top organizations across industries giving you access to roles where your contributions make a difference. Explore flexible options including contract, direct hire, and contract-to-hire, all supported by a team that puts people first.

Additional Information

If you are interested, please respond to this ad with an updated resume and a summary of your skills. We look forward to hearing from you soon.

All your information will be kept confidential according to EEO guidelines

Junior Designer, Apparel

Location: New York City (hybrid)

Pay: $20-23.40/hour (W2 and benefit options)

Duration: 3 Months, potential to extend

The Planet Group is partnering with a well-known national retail brand to hire a Junior Apparel Designer to support seasonal collection development within a fast-paced, collaborative design team. This is an exciting opportunity for an early-career designer with strong technical skills and a passion for trend-driven product development.

What You’ll Do

• Create and update detailed Illustrator sketches and flats for styles in development
• Assist in building accurate and organized technical packages (tech packs)
• Maintain sample tracking logs and update assortment/CBS sheets
• Support seasonal collection boards, walls, and presentation materials
• Attend fit sessions, take detailed notes, and follow up on revisions
• Approve strike-offs, lab dips, and development materials in partnership with cross-functional teams
• Collaborate closely with Merchandising, Production, and Graphics teams to ensure timely execution
• Research and identify trends relevant to the brand’s target customer
• Shop the market regularly for inspiration and competitive analysis
• Help manage corporate calendar deadlines and development milestones

What We’re Looking For

• 1–2 years of apparel design experience
• Strong sketching skills with speed and accuracy in Adobe Illustrator
• Proficiency in Illustrator, Photoshop, and CAD
• Experience using PLM systems is a plus
• Understanding of youth/trend-driven markets
• Highly organized with the ability to multitask and shift priorities
• Strong communication and cross-functional collaboration skills
• Bachelor’s Degree in Fashion Design or related field

Additional Details

• This role requires regular in-office presence to support team collaboration
• Occasional travel may be required based on business needs
• Additional responsibilities may evolve based on business needs

Technical Designer/Pattern Engineer

Location: Beaverton, OR

Contract length: 8 months to start

Schedule: Hybrid in Beaverton, OR

Pay: $46-48/hr, DOE (W2 and benefit options)

The Planet Group is looking for a Technical Designer/Pattern Engineer to join our well-known retail brand on a roughly 8-month contract! This role is 40 hours per week and will be hybrid in Beaverton, OR, working from home on Fridays. This person will report to the Technical Design Director and will collaborate with Design, Product Management, PCC , materials and manufacturing to effectively execute on product development & fit goals deliverables.

Technical Designer/Pattern Engineer Qualifications:

• Bachelor's degree in apparel design, textile science or related field preferred
• Additional product creation experience may be considered in lieu of a degree
• 5+ years technical design experience in the apparel industry (IDEALLY 7+) which includes the apparel development process from inception through production including pattern making, grading, construction materials, costing, manufacturing and quality
• Strong problem solving, organization and communication skills
• Experience interpreting design intent, offering alternative solutions, and acting as a technical resource
• Expert in writing product specs and construction standards instructions
• Proficient working with factory vendors to ensure and improve manufacturability
• Ability to manage multiple projects
• Experience using Adobe Illustrator, CAD Pattern Design software (Optitex) and 3D software (Clo/Browzwear) highly desired
• Proficiency with MS Office programs

Technical Designer/Pattern Engineer Description:

• Own the fit and construction from initial concept through to commercialization and production for assigned styles to lead to on time development and delivery according to critical dates, product specification, and sustainability, performance and profitability goals
• Create and revise Tech Packs for complex assigned styles
• Ensure all appropriate development documentation is maintained including product specs and prototype notes
• Drive and execute fit and construction standards for a team or product group to ensure consistency
• Track and facilitate prototyping for styles
• Identify and address key issues and challenges in construction/manufacturing and plan accordingly to deliver proven and tested product
• Monitor and communicate progress and challenges throughout the product testing process to meet product integrity requirements
• Keep abreast of market trends, team goals, new technologies and consumer needs throughout the development process and engages appropriately to ensure projects are completed within corporate guidelines and goals for all facets of product creation
• Lead the Technical Design of assigned styles product in sportswear
• Work with Design, Product Management and Product Creation Center (Asia) on tailoring the product to the specific consumer needs

Job Title: Nuclear Procedures Writer III

Duration: 12 Month

Location: Mineral VA, 23117

Schedule 3 days a week 8 hours a day. On site

Job description

The Planet Group is seeking the a Nuclear Procedure Writer III. to a Procedure Development Stakeholder identifies, defines, and approves procedures to align with I&C testing goals.

They provide input, review drafts, and ensure procedures are practical, compliant, and adopted by users

• Input & Review: Actively participate in workshops, provide subject matter expertise, and review draft procedures to ensure accuracy.
• Decision-Making: Review and approve (or reject) proposed procedures, ensuring they are practical for implementation.
• Stakeholder Engagement: Act as a liaison to manage expectations, communicate changes, and secure buy-in from impacted teams.
• Strong communication skills both verbal and written
• Ability to lead, collaborate, or work effectively in a variety of teams, including multi-disciplinary teams
• High level of accuracy in reviewing and processing technical documentation
• 2 years of experience
• Associate degree or completion of technical program in craft discipline (mechanical, electrical, instrument and controls, etc.) or nuclear operations required.
• Considerable work experience demonstrating solid working knowledge of craft specialty/nuclear operations.
• Craft discipline requirement or demonstrated nuclear operations knowledge (e.g. current/inactive RO or SRO license) may vary according to business needs and area of assignment.
• Significant work experience preparing and writing descriptive copy using publishing tools and writer guidelines, and verifying documentation, both orally and visually.
• Demonstrated ability to meet with all levels of management, and to effectively represent and negotiate issues and concerns.
• Ability to prioritize and assign work, and to serve as a technical resource to others.
• Skilled in use of computer and procedure writing software.

Duration: 3 Year Contract

The Planet Group is seeking a Senior Electrical Designer to collaborate with project teams to develop electrical designs including system layouts, schematics and wiring diagrams to create and modify electrical drawing for industrial equipment, building systems and automation.

• 7+ years of related experience and an associate degree in electrical design, drafting technology, or related fields
• Utilizing Computer-Aided Design (CAD) software (e.g., AutoCAD, Revit, SolidWorks Electrical) to create and modify electrical drawings, maintain proficiency in design software
• Designing electrical systems for industrial machinery, building systems, automation, or other applications, specify and select electrical components, equipment, and materials,
• Ensuring that electrical designs adhere to industry standards, electrical codes, and regulatory requirements,
• Collaborating with cross-functional teams, including engineers and architects, to integrate electrical systems into overall project designs
• Addressing design-related issues and provide design solutions, creating and maintaining organized documentation of electrical designs, including drawings, specifications, and bills of materials (BOMs),
• Preparing technical reports and documentation for project deliverables,
• Performing quality checks and reviews of electrical designs to ensure accuracy, completeness, and compliance with project goals.
• Strong knowledge of electrical engineering principles and design practices,
• Familiarity with electrical codes and standards (e.g., NEC, IEEE),\
• Effective communication and interpersonal skills, detail-oriented with a commitment to delivering high-quality electrical designs,
• Ability to collaborate within a team and with project stakeholders,
• Experience with PLC programming and control systems is a plus, and the ability to build effective relationships with plant staff, design engineering staff and/or vendors.

Schedule 3 days a week 8 hours a day. On site

Per diem is offered

Contract Length: 12 Months

The Planet Group is seeking the a Nuclear Procedure Writer III. to a Procedure Development Stakeholder identifies, defines, and approves procedures to align with I&C testing goals.

• They provide input, review drafts, and ensure procedures are practical, compliant, and adopted by users
• Input & Review: Actively participate in workshops, provide subject matter expertise, and review draft procedures to ensure accuracy.
• Decision-Making: Review and approve (or reject) proposed procedures, ensuring they are practical for implementation.
• Stakeholder Engagement: Act as a liaison to manage expectations, communicate changes, and secure buy-in from impacted teams.
• Strong communication skills both verbal and written
• Ability to lead, collaborate, or work effectively in a variety of teams, including multi-disciplinary teams
• High level of accuracy in reviewing and processing technical documentation
• 2 years of experience
• Associate degree or completion of technical program in craft discipline (mechanical, electrical, instrument and controls, etc.) or nuclear operations required.
• Considerable work experience demonstrating solid working knowledge of craft specialty/nuclear operations.
• Craft discipline requirement or demonstrated nuclear operations knowledge (e.g. current/inactive RO or SRO license) may vary according to business needs and area of assignment.
• Significant work experience preparing and writing descriptive copy using publishing tools and writer guidelines, and verifying documentation, both orally and visually.
• Demonstrated ability to meet with all levels of management, and to effectively represent and negotiate issues and concerns.
• Ability to prioritize and assign work, and to serve as a technical resource to others.

Skilled in use of computer and procedure writing software.

Medical Device Sales Representative Opportunity

Job Summary & Responsibilities:

The Medical Device Sales Representative supports achievement of sales revenue targets and helps to grow market share for a specified territory by promoting, selling and servicing our clients products. Practice good territory management in terms of organization, administration and expense planning. Control and train appropriate medical staff on products and procedures. This is a clinical sale with strong value added focus and an emphasis on improving patient care outcomes. Account responsibility and sales development goals established by the RSD in conjunction with the DSM.

• Traveling to hospitals and clinics operating rooms in the surrounding area.
• Responsible for specified target accounts provided by DSM and RSD.
• Provide forecast for targeted accounts with DSM guidance.
• Prospecting for new customers, driving lead follow-up, and positively positioning our products and services to existing and new clients in the region.
• Identify, establish and maintain productive working relationships with key decision makers, customers and their staff, administrative staff, etc.
• Provide clinical support for DSM (programming, reprogramming, educating clients and patients, case coverage, etc.).
• Build strong relationships with key clients.
• Train and educate customers on the merits and proper clinical usage of company products by giving presentations and demonstrations using appropriate formats and platforms (e.g., slides, manuals, etc.) to keep customers abreast of new and existing products.
• Report on sales process, market conditions, and customer activities to sales leader.
• Utilize internal platforms to ensure flawless execution of product delivery to clients and patients.
• Plan, coordinate and execute local educational and sales events, with the support of other internal resources, intended to augment the business and help to deliver assigned sales goals.
• Other duties as assigned.

Role Requirements:

• Two plus years’ of B2B sales experience.
• Bachelor’s Degree; BS in Biological Science or Business is a plus.
• 1-2 years of medical device sales experience is highly preferred.
• Operating room sales experience is a plus.
• MUST speak Spanish professionally (more than half of the patients speak Spanish).

Skills and Knowledge:

• Possesses high empathy and compassion for patients.
• Demonstrated success in previous sales role; indicating a high level of sales performance.
• Ability to plan, organize, and prioritize own daily work routine to meet region requirements.
• Travel daily within territory.
• Must have a valid driver’s license and active vehicle insurance policy
• Adheres to company policies and conducts all business in an ethical manner
• Computer proficiency.

14-month initial contract

Onsite full time in Brooklyn Park, MN facility. Flexible schedule. The blood lab usually works 6:00 am to about 3:00 pm. Sometimes folks are required to work longer to get the work done, so the candidate needs to be accommodating.

HM's Top Needs:

1. Ability handling blood (preferably in large volumes)
2. Basic wet lab skills
3. Proficiency in Microsoft Word and Excel

Education Required: High School Diploma, or Associate’s Degree (Bachelor’s degree would be overqualified and therefore, not be considered)

Years experience required: 1+ years

This position requires execution of duties in an animal/human blood lab using chemical, biological, electronic, mechanical, electromechanical and/or optical systems to assess the performance/interaction of medical devices with blood and/or equivalent test media in support of the development of new products and sustain the performance of released products. Responsibilities may include the following and other duties may be assigned. Performs a variety of technical procedures such as preparing routine solutions and reagents and performing routine reactions. Testing includes preparation of devices in perfusion circuits, circulating blood/test fluid through test circuits, and sampling blood/fluid at various time points. Makes and records observations; performs simple calculations; and collects and prepares data for evaluation. Conducts laboratory support functions such as stocking and distributing supplies and equipment; arranging and dismantling apparatus; and collecting, washing, and storing labware. Performs technical and record keeping duties in conformance with company and regulatory policies and standards to meet quality and accuracy requirements. May analyze biological and chemical samples. Performs technical procedures in one or more of the following areas: Production, Research and Development, Quality Control/Assurance, and/or Compliance/Environmental.

TECHNICIAN SUPPORT CAREER STREAM: Provides technical support in areas such as production, operations, maintenance, safety, testing, process improvement or product development. Uses schematics, diagrams, written and verbal descriptions or defined plans to perform testing and troubleshooting on blood-contacting components, equipment or systems. Gathers, maintains, formats, compiles, and manipulates technical data using established formulae and procedures, and performs detailed mathematical calculations. For higher levels, may suggest and/or make improvements to optimize work processes.

DIFFERENTIATING FACTORS

Autonomy: Established and productive individual contributor, working under moderate supervision. Performs tests, interprets data and develops reports.

Organizational Impact: Performs intermediate technical activities requiring judgment and decision-making. Work consists of technical tasks that are typically routine.

Innovation and Complexity: Technical problems faced are generally routine but may require interpretation of procedures or policies to resolve problems. May be required to highlight areas of concerns/problems in own job area.

Communication and Influence: Communicates typically with internal contacts. Obtains and provides technical information requiring some explanation or interpretation.

Leadership and Talent Management: May provide guidance and assistance to new or entry level employees.

Required Knowledge and Experience: Requires basic job knowledge of systems, techniques and procedures obtained through prior work experience or education. Requires minimum of 2 years of relevant experience; may require vocational or technical education or certification in addition to prior work experience.

CONTRACT: 12-month extendable

Schedule: 7pm-7am: rotating schedule and will support onsite every other weekend

MUST HAVES:

• Scientific degree and/or courses/interest in science OR Manufacturing Experience

Job Description:

The Manufacturing Associate is responsible for the manufacturing of therapeutic proteins (API) under cGMP conditions.

• Associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment.
• They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in handling of products and materials.
• Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate.
• Attain qualification for all assigned tasks and maintain individual training plan.
• Perform material movements, transfer raw materials, chemicals into, out of, across the production areas.
• Maintain facility and equipment through routine cleaning and sanitization, support 6S programs. Must be willing to gown and work in a "clean room" environment.
• Administrative tasks - attending shift exchange, meetings, sending/receiving emails, participating in projects.
• Perform other duties as assigned.

Requirements:

• Scientific degree and/or courses/interest in science OR Manufacturing experience

-6 month contract

-Pay: $28/hr

Night Shift (4:30pm – 4:45am, Thu – Sat [rotating Wed])

Position Description

The Manufacturing Technician is responsible for the aseptic manufacturing of tissue-based (human and porcine) products for the regenerative market. This position involves operating simple processing equipment and manual handling of tissue to transform it into a finished product for our customers. To ensure product quality, this role much adhere to standard procedures and cGMP (Current Good Manufacturing Practices).

Main Areas of Responsibilities

• Works in a cleanroom or regulated area to process human and/or porcine tissue

• Adheres to standard operating procedures and cGMP

• Operates simple processing equipment including, but not limited to: heat sealers, biohazard laminar flow hoods, and mixers

• Monitors the quality of pre-packaged finished goods during production

• Records information on batch records, equipment and cleaning logs, and other documents.

• Uses computers, barcode scanners, and SAP to enter data and generate reports

• Maintains inventory of processing supplies

• Responsible for the sanitization of the facility

Qualifications

The below skills are attributes that may not be mandatory but are desired in the ideal candidate.

• High school diploma or equivalent required

• Minimum 1-2 years of related manufacturing experience, preferred

• Must have willingness to learn all equipment and jobs in the assigned processing area

• Ability to maintain a safe working environment and practice safe working habits

• Demonstrated attention to detail and adherence to procedures

• Demonstrated oral and written communication, critical thinking, arithmetic and proper business etiquette skills

• Must be willing and able to work with potentially biohazardous materials, including cadaveric tissue

• Ability to work in a cleanroom environment with proper gowning attire

• Ability to lift up to 30 pounds of boxes and materials off racks

• The position involves frequently sitting, walking, reaching, stooping, squatting, crouching, kneeling, crawling and stair climbing and has the ability to use fine motor skills to operate equipment and or machinery

Portsmouth, NH

12-month contract, potential for extension or conversion

Nights - 7PM - 7AM

The Manufacturing Associate is responsible for the manufacturing of therapeutic proteins (API) under cGMP conditions. Associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in handling of products and materials.

• Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate.

• Attain qualification for all assigned tasks and maintain individual training plan.

• Perform basic laboratory tasks, such as monitor pH, conductivity, test product samples, etc.

• Perform material movements, transfer raw materials, chemicals into, out of, across the production areas.

• Maintain facility and equipment through routine cleaning and sanitization, support 6S programs. Must be willing to gown and work in a "clean room" environment.

Administrative tasks - attending shift exchange, meetings, sending/receiving emails, participating in projects.

• Perform other duties as assigned.

Sr. Associate

Thousand Oaks, CA (Onsite)

1 Year Initial Contract

Pay: $26/hr

Job Details: To perform experiments, organize data and analyze results under minimal supervision. With minimal supervision, plans, conducts or monitors experiments, records and organizes data, analyses results, generates robust and reliable data and/or Ensures that contracted studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Responsibilities include:

? Monitors or follows established experimental design and protocols and performs routine tasks and studies to obtain reproducible and reliable results with limited supervision

? Plans, monitors or conducts, analyzes and records experiments, and provides interpretation of data

? Develops and implements new protocols with moderate review

? Engages coworkers in scientific discussions

? Communicates data and interpretation to work group

? Skilled at developing systems to ensure quality data

? Skilled and/or knowledgeable in the use of standard laboratory equipment and with one or more major laboratory instruments/techniques

? Effectively trouble-shoots equipment and experimental difficulties ? Contributes to internal/external reports, papers, presentations, regulatory documents, invention disclosure submissions and/or patents

? Participates in department-wide support efforts such as safety, recruiting and committees

? May train staff and/or supervise others

? Coordinates and organizes resources needed to complete the task

? Understands when to seek input and when to make independent judgments

Day to Day Responsibilities:

Lab-based position. Responsible for sample analysis with a variety of analytical techniques (LC, CE, particle analysis, compendial methods). Responsible for supporting the timely execution of process related experiments to enable tech transfers to manufacturing sites. Candidate will be required to document study/analysis execution and interpret/present results and conclusions. Participate in team/group meetings.

Requirements:

• Degree in Biology, Biochemistry or Analytical Chemistry or related field
• Experience in a Biopharmaceutical working environment
• Experience with typical bio characterization techniques such as liquid chromatography techniques, capillary electrophoresis including troubleshooting strongly preferred.
• Good interpersonal skills, the candidate will be working in a very team-focused environment. Familiarity/experience with biologic process development.

Shift options: Hours are 2:00pm - 10:30pm, Hours are 10:00pm - 6:30am

Lab Analyst I

This position performs routine testing on all samples in the Analytical Services laboratory, providing analytical data for process control, quality control, process development, product development, and waste management. Employee will be required to work eight hours shifts, and rotating days within shift every three to four months. KC Quality Control lab is a 24 hours production site that operates on three shifts.

YOUR TASKS AND RESPONSIBILITIES

• Perform routine analytical testing as directed by protocols and work instructions.

• Work a variety of shifts (including weekends and holidays).

• Request additional work to increase team productivity.

• Prepare solutions, clean glassware, dispose of solid/liquid waste and other duties to help in the overall operations of the laboratory.

• Train others on waste management.

• Alert lab leadership of issues or discrepancies involving sample integrity, supply inventory, safety concerns, or analysis irregularities.

• Communicate troubleshooting opportunities in testing processes.

• Perform routine analytical testing as directed by protocols and work instructions.

• Work a variety of shifts (including weekends and holidays).

• Request additional work to increase team productivity.

• Conduct basic (operational) preventative maintenance according to work instructions. Identify and communicate operational issues of laboratory instruments and equipment KPIs Understand and operate Laboratory Information Management System (LIMS), Chromatography Data System (CDS) system, and other instrument specific computer systems.

• Search various databases for test methods, specifications, and standards to locate information required to complete analyses.

• Promptly and accurately record, calculate and report analytical results.

• Review analytical data and various LIMS reports.

• Communicate and discuss any issues with team members and supervisor.

• Complete data entry for metrics and KPIs Identify process improvement ideas and communicate opportunities.

• Assist in improving established procedures and implementing continuous improvement projects.

• Communicate testing results to customers as required; act with customers in mind. Notify leads when supplies/consumables are at critical levels.

• Observe good safety and housekeeping practices.

• Participate in lab/site safety programs and cross site initiatives.

• Maintain knowledgeable of RCRA hazardous waste regulations, waste determinations, waste codes, and how to immediately communicate discovery of spills and leaks

Required Qualifications:

• High school diploma + a minimum of 1-year lab experience

• Good oral and written communication skills.

• High attention to details and an ability to analyze outcomes against a standard.

• Ability to diagnose the typical instrument problems with little or no assistance and provide assistance to others.

• Ability to multitask and prioritize workload to optimize efficiency and productivity of the laboratory.

Preferred Qualifications:

• 3+ years laboratory experience

• Understands basic HPLC and GC operation.

Duties:

Document Technician: The main responsibilities are: Conduct a file review in the retention warehouse (Chicago Records). Provide a daily report about the case file reviewed. Conduct and verify the inventory of record cases by Department. Participate in follow-up meeting to review these results.

Skills:

Applies acquired knowledge and skills to complete standard tasks Readily learns and applies new information and methods to work in assigned area Maintains appropriate licenses, training and certifications Works on routine assignments that require some problem resolution Works within clearly defined standard operating procedures and/or scientific methods Adheres to all quality guidelines Works under moderate degree of supervision Work typically involves regular review of output by work lead or supervisor Refers complex unusual problems to supervisor

Education:

HS Diploma, GED or equivalent experience, preferred 1-2 years experience in related field, preferred

The ideal candidate loves talking to people and proactively solving issues.

Job description:

• Monitors and addresses telephone calls through ACPRU clinical subject recruitment call system.

• Pre-screen potential subjects using approved recruitment questionnaire and discuss previous medical history per subject.

• Assigning subject number E-source including entering demographics and medical history information.

• Responsible for performing duties to ensure studies conducted at the ACPRU are filled with qualified clinical trial subjects.

• Responsible for timeliness of follow-up calls for each subject including overview of study objectives with inclusion/exclusion criteria, length of trial, number of outpatient visits, missed screening appointment, check-in reminders call, screening cancellations within 24 hours.

• Ensure response to and assignment of all inbound, outbound, email and text messages within 24 hours.

• Assist in identifying future ACPRU needs and identify new strategies to recruit trial subjects based on previous database use and trial enrollment.

Call Center average quarterly of calls is between 4-5k volume

Qualifications:

- Phone center experience (must have). Someone used to call volume and processing calls will be ideal candidate

- Associate's degree or higher

- Basic medical knowledge

Biotechnician – Conjugation

Duties:

Performs efficiency studies (assays) and pre-clinical exploratory safety studies. Performs testing of clinical, research and quality control proficiency; evaluates instruments. Evaluates and analyzes clinical research data. Coordinates activities of associates and investigators to ensure compliance with protocol and overall clinical objectives. Manages storage of research samples.

Skills:

Assays

Education:

Associates