Pai Pharma Jobs in Usa

Company Description

Bird Dog Pharma helps medical practices seamlessly integrate physician-directed allergy care into their routine clinical workflows, ensuring continuity of care for patients. Focused on empowering practices to address allergy-driven conditions such as asthma, eczema, and sinus complaints, Bird Dog Pharma supports providers with in-office testing, personalized immunotherapy, and operational integration. By simplifying allergy care, we enable physicians to deliver comprehensive treatment within their own offices. Our mission is to make allergy care practical, sustainable, and accessible for healthcare providers.

Role Description

This is a contract, remote position for a Medical Sales Representative. The role involves engaging with medical practices to promote and support the adoption of Bird Dog Pharma's allergy care solutions. Responsibilities include building and maintaining client relationships, educating healthcare professionals on the company's offerings, and identifying opportunities to expand sales territories. The ideal candidate will conduct market research, provide customer service to medical providers, and achieve sales goals while maintaining a consultative approach.

Qualifications

• Proven experience in Medical Sales and a track record of meeting or exceeding sales targets
• Strong Communication and Customer Service skills for building relationships and delivering excellent support
• Knowledge of Medicine and Pharmacy principles, with a focus on allergy care or a related field
• Self-motivated with the ability to work independently in a remote capacity
• Experience working with healthcare professionals or within a clinical environment is preferred
• Strong organizational skills and adaptability to meet the needs of a fast-paced, dynamic role

Company Description

Patrin Pharma, Inc. is a mid-size, growing pharmaceutical company located in a northern Chicago suburb. In business for nearly 20 years, Patrin has been expanding its product portfolio and distribution footprint. As a smaller and agile organization, senior leaders operate with broad scope and direct impact on strategy, growth, and decision-making.

Position Summary

The National Accounts and Trade Relations Manager is responsible for driving revenue growth through strategic management and expansion of distributor, GPO, and trade relationships. This role combines external relationship leadership with strong commercial analytics to optimize sales performance, distribution strategy, and product pull-through. This position partners closely with the contracts and finance team to ensure commercial strategy aligns with pricing execution, contract performance, and margin objectives. This is an on-site position.

Key Responsibilities

Distributor & Trade Relationship Management

• Build and manage relationships with pharmaceutical distributors, GPOs, and other purchasing partners.
• Serve as the primary commercial liaison between Patrin Pharma and trade partners.
• Conduct regular business reviews and planning sessions.
• Communicate proactively with purchasing partners to remain aligned on market shifts, competitive dynamics, and supply considerations.
• Learn and maintain deep knowledge of customer accounts

New Distributor & Channel Expansion

• Identify, evaluate, and pursue new distributor and specialty channel opportunities.
• Lead commercial discussions and onboarding efforts for new trade partners.
• Expand product listings and improve portfolio visibility across distribution networks.
• Support new product launches within distribution channels.

Market & Sales Monitoring and Analysis

• Monitor competition, sales trends, market share, utilization, price competitiveness, and supply issues across all products.
• Review direct sales and chargeback data to assess product pull-through and channel effectiveness.
• Identify revenue growth opportunities and recommend commercial strategies based on data insights.

Contracting & Competitive Positioning

• Lead submission for contracting opportunities including RFP submissions.
• Communicate Patrin’s competitive positioning and value proposition to trade partners.
• Track contract volumes against expected volumes and identify performance gaps.
• Monitor contract lifecycle and performance in collaboration with Pricing.

Cross-Functional Leadership

• Collaborate with Pricing, Finance, and Operations to align revenue and margin goals.
• Provide market intelligence to support pricing decisions.
• Ensure smooth execution of commercial agreements post-negotiation.

Qualifications

• 5–10+ years of experience in pharmaceutical distribution, generics sales, or trade/channel roles.
• Demonstrated experience working directly with distributor category managers and GPO decision-makers.
• Strong understanding of pharmaceutical distribution economics including chargebacks, rebates, and contract structures.
• Proven record of revenue growth and account expansion.
• Strong analytical skills with ability to translate data into commercial action.
• Excellent negotiation and communication skills.
• Experience with a smaller or mid-size company preferred
• Bachelor’s degree in Business, Finance, or related field.

Medical Device Sales Associate needed!

About the Opportunity:

We are seeking a driven Associate Interventional Specialist to support a high-performing Territory Manager in the Westchester/Fairfield County territory. This is a growth opening due to internal promotion and offers strong development into a full Territory Manager role. This is an exciting time to join a profitable, expanding organization committed to improving the lives of chronic pain patients within the neuromodulation and broader musculoskeletal space.

Key Responsibilities:

• Support Territory Manager with daily field activity and account coverage
• Assist in implant procedures and provide in-OR clinical support
• Provide programming and reprogramming support for patients
• Educate physicians, clinical staff, and patients on therapy and product benefits
• Conduct sales calls to maintain and grow existing accounts
• Manage assigned target accounts as designated by the District Sales Manager
• Develop new business through trial generation and account penetration
• Plan and execute local educational programs and sales events
• Maintain inventory and territory organization
• Complete all compliance and regulatory training requirements

What We’re Looking For:

• 2–3 years of business-to-business sales experience (medical device, pharma, biotech, clinical, or related industry preferred)
• Bachelor’s degree required
• Strong communication and influencing skills
• High character, strong work ethic, and willingness to work flexible hours (including occasional weekends for procedures)
• Valid driver’s license and ability to travel daily within the territory
• Not a job hopper — demonstrated tenure and career progression preferred
• Operating room experience is not required. Candidates from structured sales training environments (e.g., enterprise sales organizations) or early-career medical device professionals are encouraged to apply.
• MUST live within the territory (Danbury/Westchester/Fairfield, CT)

Position Summary:

We are seeking a detail-oriented and motivated Junior Accountant to join our Finance team,

with a specialized focus on pharmaceutical accounting. This role is ideal for someone with

foundational accounting experience and a strong understanding of the pharmaceutical

industry’s understanding of G2N and revenue analysis, rebate structures, including

commercial, Medicaid, and Medicare Part D programs.

Key Responsibilities:

• Assist in the preparation, review, and processing of rebate claims and accruals.
• Support monthly, quarterly, and annual financial close activities related to rebates.
• Reconcile rebate-related accounts and ensure accuracy of general ledger entires.
• Collaborate with cross-functional teams including Sales, Contracts, and Market Access to validate rebate data.
• Maintain documentation and audit trails for all rebate transactions
• Assist in preparing reorts and analysis for management and external auditors
• Ensure compliance with GAAP and internal financial policies
• Participate in system upgrades or implementations related to rebate tracking and accounting
• Perform other duties as assigned

Qualifications

• Degree in Accounting, Finance, or related field
• 1-3 years of accounting experience, preferably in the pharmaceutical or halthcare industry
• Familiarity with rebate programs (e.g., Commercial, Medicaid, Medicare Part D)
• Strong Excel Skills; experience with ERP systems (e.g., QuickBooks, SAP) is a plus
• Excellent attention to detail and organizational skills
• Ability to work independently and as part of a team in a fast-paced environment

Preferred Skills

• Experience with contract management systems and rebate processing platforms
• Understanding of government pricing regulations and pharmaceutical compliance
• Strong analytical and problem-solving abilities

To all recruitment agencies: Luye does not accept unsolicited third party resumes, and all resumes must be submitted to HR Function.

The starting compensation range(s) for this role are listed for a full-time employee (FTE) basis. Additional incentive may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Luye Pharma is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

Job Description – Technical Business Development Director （Antibody–Drug Conjugate-Boston)

General:

Porton Pharma Solutions Ltd. a leading pharmaceutical CDMO company that provides global pharmaceutical companies with innovative, reliable, and end-to-end process R&D and manufacturing services across small molecule & new modality APIs, dosage forms, and biologics.

This BD role is responsible for driving business breakthroughs in the U.S. ADC market through proactive client engagement and strategic business development. The key focus includes building and expanding ADC client relationships, influencing key decision-makers, identifying client needs and market opportunities, and gathering competitive intelligence. This role will also lead contract negotiations and deal execution to secure new business and support the company’s growth strategy in the ADC field.

1. Position Profile:

• Position Title/Grade: Director to Sr. Director
• Position Type: Individual Contributor/Technical Solutions Support
• Work Location: Remote work, living in the greater Boston area is preferred
• Direct Supervisor: Executive Director, lead of New Modality BD Team

Key Responsibilities:

Develop and Strengthen ADC Client Relationships in the U.S.

• Actively develop and expand relationships with ADC clients in the U.S. by deeply understanding their business needs, technical challenges, and strategic priorities.
• Provide tailored solutions that address client pain points and create long-term value, enhancing trust and partnership.
• Regularly meet with clients through face-to-face visits, business presentations, and participation in industry events to build new relationships from the ground up (0–1 stage).
• Identify key decision makers within target organizations and establish strong, influential connections.
• Build a strategic client network to support sustainable growth in the ADC business.

Drive Client Engagement and Influence Key Stakeholders

• Proactively engage with both existing and potential ADC clients to increase awareness of the company’s capabilities and services.
• Conduct in-depth business and technical discussions to better understand clients’ priorities and influence their decision-making processes.
• Effectively position the company’s technical strengths, project track record, and service advantages to enhance its competitiveness in the U.S. ADC market.
• Strengthen strategic relationships with decision-makers, influencers, and other stakeholders critical to business development.

Identify Market Opportunities and Customer Needs

• Continuously collect, analyze, and track client feedback to identify their evolving business needs and market opportunities.
• Monitor ADC industry trends, technology advancements, and regulatory developments to anticipate changes in client demands.
• Maintain close communication with internal cross-functional teams—including R&D, manufacturing, quality, and project management—to ensure timely alignment with customer requirements. Collaborate with CC3 (TS/PL, PMM) and New Modality R&D and manufacturing teams to align on customer needs and project delivery.
• Support the development of commercial strategies based on real-time market and customer intelligence.

Gather and Analyze Competitive Intelligence

• Regularly monitor competitors’ public information, including market activities, product launches, strategic announcements, and financial disclosures.
• Utilize professional market research institutions, industry databases, and analytical tools to assess competitors’ market share, pricing trends, customer perception, and business strategies.
• Provide detailed, actionable intelligence to support internal decision-making, commercial positioning, and competitive strategy development.
• Identify gaps and opportunities to strengthen the company’s competitive advantage in the U.S. ADC market.

Lead Contract Negotiations and Drive Business Breakthroughs

• Take full responsibility for leading commercial discussions, contract negotiations, and deal execution with U.S. ADC clients.
• Clearly articulate the company’s technical advantages, operational capabilities, and successful project cases to enhance client confidence and close deals.
• Work with internal teams to create flexible commercial policies, such as pricing optimization, service upgrades, or partnership models, to meet client needs and increase win rates.
• Achieve breakthrough growth in the U.S. ADC business by securing new projects and expanding the company’s market presence.
• Contribute to the company’s overall commercial goals by meeting or exceeding revenue and growth targets.

Technical Solutions Support

• Assist BD in pipeline prioritization and high-value project identification through commercial insights, pinpointing business opportunities, and leading the development of technical guidance plans for target clients.
• Understand client research and development needs, identify pain points, and activate potential leads. During the inquiry phase, provide guidance and technical input to shape client needs.
• Develop and implement technical guidance plans to advance identified opportunities with key clients, collaborating with the Business Development team to establish and expand comprehensive client relationships.
• Assist the Business Development team with proposal development and pricing strategies. Provide expert project management and technical input into new business budget development and bid defense meetings.
• Lead the interpretation of client requirements, clarify needs, enhance or reshape project concepts at the Request for Proposal (RFP) stage.
• Oversee technical solution interpretation during the pricing phase and work closely with the PMM and delivery teams to address technical issues outlined in contracts.
• Engage in the co-creation of solutions to major technical challenges during project delivery.

Qualifications:

• A Master or Ph.D. degree in Biology, Pharmacy, or other related life science areas is required.
• Minimum of 5-10 years of hands-on business development experience in the CDMO industry with a focus on ADC services.
• Existing ADC client resources or prior involvement in strategic partnership building is required.
• Demonstrated ability to identify and engage ADC clients, maintain strong business relationships, and successfully drive deal closures.
• Solid knowledge of ADC-related scientific and technical principles, applicable regulatory and legal requirements, and commercial and marketing practices.
• Familiarity with the ADC development process, including early-stage development, clinical manufacturing, and commercial considerations.
• Familiarity with the ADC development process, including early-stage development, clinical manufacturing, and commercial considerations. Relevant experience in antibody CRO BD or pharmacology BD will also be considered.
• No formal management experience required, but the ability to operate independently and influence internal and external stakeholders is expected.
• Bilingual proficiency in English and Chinese is required to support cross-border client communications and business activities.

Core Competencies:

• Strong interpersonal skills and approachability: able to build and maintain positive relationships with clients and colleagues.
• Proactive and results-oriented mindset: self-driven, goal-focused, and able to take initiative.
• High resilience under pressure: adaptable, persistent, and able to perform effectively in a fast-paced and challenging environment.
• Strong learning and analytical abilities: quick to understand new concepts, with solid skills in synthesis, problem-solving, and critical thinking.

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.

Position Summary:

The Senior Manager, Quality Operations will be responsible for Quality project management of pre-clinical and clinical programs by providing GXP support to Atsena Therapeutics’ Clinical, CMC, and Nonclinical teams through management of documentation review, compliance trending and maintenance of quality issues, and vendor oversight. The Senior Manager, Quality Operations will implement and maintain the Quality Management System (QMS) through quality standards, policies, and procedures, including document management in the Veeva Vault QualityDocs platform. The Senior Manager, Quality Operations will assist in GXP risk assessment activities in collaboration with business stakeholders and ensure compliance with global regulatory, vendor, and internal company quality systems requirements.

Responsibilities:

• Partners with Atsena’s Clinical, CMC, and Nonclinical teams, external vendors, and investigator sites to provide GXP Quality oversight including assistance in risk assessments and quality oversight initiatives.
• Collaborates with external vendors; and Atsena Clinical, CMC, and Nonclinical teams to provide GXP and QA expertise while ensuring project objectives are met in a compliant and timely manner.
• Assesses compliance of vendors, investigator sites, study activities, etc. with study protocols, SOPs, and ICH and other applicable regulatory requirements.
• Develops and implements the internal/external GXP audit program for their clinical program(s), including scheduling, consultant oversight and audit report review and approval.
• Leads significant Quality issues management system for assigned studies, including assessment of potential root causes and remediation (corrective and preventative actions).
• Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation, with programs/products to Leadership.
• Assists and implements initiatives that promote and maintain a quality culture and awareness towards Data Integrity and Good Documentation Practices.
• Supports GXP PAI readiness activities by partnering with internal operational and Quality leadership.

Qualifications:

Bachelor’s Degree required, preferably in life sciences. Minimum 5-7 years’ experience working within the biotech or pharma industry, with biologics and/or gene therapy experience preferred. Quality assurance pharmaceutical experience, with experience in clinical research, GCP, GMP and QA compliance. Knowledge and understanding of pre-clinical and clinical development programs and clinical trial processes as well as quality management system. CQA Certification preferred. Experience in implementing Quality Management Systems. Experience with VeevaVault preferred. Knowledge of FDA regulations, ICH standards and other regulatory requirements. Ability to manage multiple projects in a dynamic and fast paced environment.

Competencies:

• Accountability & Self-Management
• Communication
• Open Minded & Innovative
• Planning & Organization
• Problem Solving
• Quality
• Teamwork

The Spear Group Full-Time w/ Benefits

Position:

P6 Scheduler – Owner’s Side, Pharma Manufacturing Capital Projects

Location:

Linden, NJ Area

ON SITE

NJ Local Candidates Only Please

Position Summary:

The Spear Group has an excellent career growth opportunity for an experienced Owner’s Side Capital Project Scheduler to be part of an exciting life sciences capital project controls team in the Linden, NJ area. This on-site NJ Scheduler /project controls professional is an owner’s side Scheduler and supports the pharma client’s owner’s side project controls team to contribute to successful capital project delivery. This P6 Scheduler position is a key project controls team member of a highly integrated pharma manufacturing CAPEX project delivery team working to deliver a top-tier, innovative pharma manufacturing facilities.

Key Responsibilities:

Provide Scheduling support with collaborative team focus driven to support planning requirements including all phases from project inception through qualification. The position requires being a self-starter while communicating with all stakeholders to provide scheduling / planning deliverables and updates as necessary.

• SCHEDULING responsibilities are to help develop, maintain, and report on the Master Project Schedule utilizing lean project management methodologies and other industry capital project delivery approaches, best practices, and tools ( i.e. Primavera 6 / P6 , OPC, TAKT, Last Planner System, Pull Planning, Netpoint….). Manage Schedule Progress Measurement/Percent Plan Complete (PPC) and variance analysis and ensure changes are captured in Project Schedule as well as communicated to PC team and project delivery team and stakeholders.
• Illustrate experience with all aspects of project execution by enabling interactive scheduling and planning sessions to drive team participation in overall project plan. Provide scheduling and project controls support to prepare monthly Project Control reporting deliverables. Ensure timely communication and support of project reporting requirements
• Demonstrate excellent communication and interpersonal skills to work as a team to collaborate effectively with all levels and all capital project team members to ensure understanding of planning/scheduling requirements and continuous improvement of data, tools, and processes; in a Integrated Project Delivery (IPD) environment. Possess leadership skills necessary to transform and sustain a high performing group of technical project controls professionals. Drive scheduling and planning development for projects and attend recurring and non-recurring project related meetings as required.
• Knowledge of the pharmaceutical/life sciences industry is preferred but related project-based industry P6 scheduling experience will be considered as well, including CM / Construction Management P6 scheduling experience. EXPERIENCE in strategic planning/scheduling and Lean Project Delivery Best Practices (e.g. Target Value Delivery, Last Planner®, Takt planning, Touchplan®, NetPoint®) is a significant plus, along with knowledge of AE, CM, and Professional Service providers planning/scheduling means and methods.

Required Experience and Education:

• 2+ years of experience in scheduling and project control functions.
• Experience with Life Sciences / Pharma / BioPharma Capital Projects or other industry project-based scheduling project controls experience (i.e. oil & gas , energy , CM , healthcare, commercial , industrial / manufacturing facility capital projects
• Proficiency in MS 365 and Primavera® / P6 and MS Project
• Working knowledge of Target Value Delivery, Last Planner®, Takt planning, Touchplan®, NetPoint® is a significant an added plus if possible.
• Bachelor’s degree in construction, engineering, finance, or related
• Ideal candidate is results driven with an operational readiness perspective, has technical capability in the field, and is a self-starter with excellent interpersonal skills.

Compensation based on relevant experience

EQUAL OPPORTUNITY EMPLOYER

The Spear Group, Inc. is an Equal Opportunity Employers. All personnel actions are affected without regard to race, color, sex, age, religion, national origin, disability, veteran status, or other protected status pursuant to law. As a responsible organization, we resolutely support the concept and practice of Equal Employment Opportunity. We uphold federal, state, and local civil rights laws and work to ensure that all of our personnel actions and policies are in compliance. Additionally, we recognize and value the importance and diversity of our work force and support its various cultures. The Companies are dedicated to fostering an environment that respects the dignity, rights and contributions of our employees.