Pai Pharma Jobs in Usa

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.

• Enterprise Architecture & Design Authority
  • Serve as the overall owner of the architectural standards, design conventions, and configuration patterns for all Datex WMS workflows.
  • Define and enforce enterprise-wide WMS architecture, including warehouse blueprints, workflow standards, integration patterns, and compliance frameworks.
  • Validate and approve all WMS design changes from onshore/offshore teams.
  • Maintain a detailed understanding of current and future-state warehouse processes, regulatory expectations, and operational pain points.
• Leadership of Onshore & Offshore Teams
  • Lead, mentor, and support WMS workflow developers, analysts, and QA testers across both onshore and offshore teams.
  • Assign priorities, manage workloads, and ensure timely delivery of enhancements, fixes, client onboarding tasks, and projects.
  • Build capability across teams with training, playbooks, process maps, and reusable design components.
  • Operate as escalation point for configuration, design, integration, and environment issues.
• Pharma Distribution & Regulatory Compliance
  • Ensure all workflows adhere to DSCSA, cGMP/GDP, 21 CFR Part 11, and audit trail/e-signature requirements.
  • Oversee validation strategy for WMS changes including URS, FRS, IQ/OQ/PQ, traceability matrices, and controlled releases.
  • Partner with Quality to ensure readiness for regulatory audits, client audits, and compliance reviews.
• Workflow Strategy & Solution Design
  • Architect efficient workflows for:
    • FEFO/expiry-driven allocation
    • Lot/batch/serial control
    • Quarantine/QA/hold/release
    • Temperature-controlled workflows
    • Controlled substances handling
    • Multi-client 3PL billing
    • VAS/kitting/custom pharma processes
  • Optimize RF flows, wave strategies, replenishment logic, bin strategies, and exception-handling.
• Integration & Data Ecosystem Ownership
  • Oversee integration design with ERP, TMS, carriers, automation, and serialization systems.
  • Approve EDI/JSON/XML mappings for inbound/outbound data.
  • Lead architecture for event-driven, API-based, or serverless integration components.
  • Guide data governance across item master, location master, client profiles, and regulatory attributes.
• Production Environment Leadership
  • Serve as top-level escalation point for major incidents, outages, and complex RCA.
  • Govern change control, release management, environment synchronization, and configuration versioning.
  • Drive continuous improvement initiatives, reduce defects, standardize processes, and elevate operational KPIs.
• Cross-functional Leadership
  • Partner with Operations, Quality, Engineering, Customer Solutions, Client Onboarding, and leadership to define requirements, evaluate impacts, and build scalable solutions.
  • Support RFP responses, client onboarding, and solution design sessions for new 3PL clients.
  • Communicate architecture decisions and impacts to executive stakeholders.
• Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias.
• All other duties as assigned.
  

• Responsible for and oversee their respective department.
• Interview, select and supervise the activities of the department staff; communicate interpret and discuss with team the company policies and procedures.
• Determine job objectives, work methods and performance standards; review performance relative to departmental objectives discussion appraisal with each employee and performance; authorize and communicate salary changes, promotions, transfers, discipline, and discharge and administer all other personnel actions.
  
  

• Travel (15-25%)
• Hours (40+ hours per week, Monday-Friday)
  
  

• Bachelor’s degree in Information Systems, Supply Chain, Engineering, Computer Science, or related field.
• 7–10+ years of hands-on experience with Datex WMS in configuration, workflow design, and architecture.
• 5+ years in a leadership role guiding onshore and offshore teams.
• Deep expertise in pharmaceutical distribution, including:
  • DSCSA traceability
  • cGMP/GDP
  • 21 CFR Part 11
  • Audit trails, e-signatures
  • Cold chain / temperature-controlled workflows
• Extensive experience in 3PL multi-client environments.
• Strong understanding of all core warehouse processes (inbound, putaway, replenishment, picking methods, VAS, returns, QC, cycle counting).
• Strong SQL Server experience (queries, stored procedures, debugging).
• Strong experience working within GxP validation frameworks (URS/FRS, IQ/OQ/PQ, CAPA, change control).
• Exceptional communication skills; ability to translate between business, operations, and technical teams.
  

• Advanced certifications in supply chain or WMS technologies are a plus.
• Experience designing or supervising Azure Functions or Node.js/TypeScript utilities for integration or workflow extensions.
• Experience with ERP systems (SAP, Oracle, Microsoft Dynamics) and TMS/carrier integrations.
• Exposure to warehouse automation (AMRs, conveyors, print-&-apply, dimensioners, pick-to-light/put-to-light).
• Familiarity with serialization or regulatory platforms (TraceLink, SAP ATTP).
• Power BI/Tableau for operational data models.
  
  

Company/Role Overview:

CliftonLarsonAllen (CLA) Search has been retained by Optima Machinery Corporation for their Pharma Division to identify Automation & Controls Technicians to serve their team. With locations and customers all over the world, Optima Machinery Corporation designs and builds packaging and filling machines including complete production lines for pharmaceutical, consumer, nonwovens and life science products.

The Automation & Controls Technician position supports the Optima Pharma Division in an enhanced service role pertinent to the operations of that division. The Automation & Controls Technician position is a full-time, hourly role that requires availability for service and continued training. This job operates in a production environment at the customer's site and requires strict adherence to the customer's safety measures while working both independently and as part of a team.

This job is fully remote and can be based anywhere in the U.S. Travel to Optima Machinery Corporation locations in Raleigh, NC, Green Bay, WI, and Germany will be required. Total travel requirements for this position is 70 – 80%.

To learn more, click here:

What You’ll Do:

• All aspects of control system installation, from control panel assembly, field wiring, machine installations, machine troubleshooting, and general electrical services.
• Installing machines and making the process adjustments both mechanically and electrically for efficient operation.
• Servicing existing machines at customer’s facilities. Implementing upgrades and improving running efficiency.
• Interface with clients as well as subcontractors and solve issues and problems to the satisfaction of the company and client.
• Ability to utilize a laptop to troubleshoot machinery controls systems.

What You’ll Need:

• An Associate’s degree or equivalent from a two-year technical school in Electro Mechanical or related degree; Exposure to courses in Programming/PLC Logic or more than 5 years hands on experience with Optima pharma equipment.
• Minimum of 2 years’ experience working with industrial machines.
• SAP experience ideal.
• Excellent interpersonal, verbal, and written skills
• Ability to deal with experienced, multidisciplinary, technical specialists
• Ability to coordinate small to large projects independently
• Ability to download PLC, HMI, and drive programs. Ability to work with controls engineers to identify and improve machine programs.
• Significant electrical aptitude and knowledge of acceptable practices, techniques, and codes. Comfortable reading and following IEC electrical diagrams.
• Thorough working knowledge of industrial controls devices including photo-electric sensors, proximity switches, solenoid valves, frequency and servo drives, and PLC I/O.
• Experience in executing change control and good understanding of data integrity 21CFRp11.
• Ability to tune PID loops and perform loop check as in commissioning.
• GMP/GDP Automation experience preferred.
• Rockwell/Allen-Bradley PLC (Control Logix and Compact Logix) and HMI experience a plus.
• Travel requirements for this position is 70 – 80%

About Made Scientific

Made Scientific is a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

Position Summary

The Inspection Readiness Lead (Associate Director) is a quality leader responsible for establishing, maintaining, and continuously improving a state of inspection readiness across GMP cell therapy operations, spanning clinical through commercial stages. Reporting to the VP of Quality and Compliance, this individual partners closely with the Site Quality & GMP Compliance Lead and key cross-functional stakeholders to ensure GMP alignment, consistent execution, and inspection readiness across regulatory interactions.

Key Responsibilities

Inspection Readiness & Regulatory Compliance

• Design, implement, and sustain an inspection readiness program supporting clinical and commercial cell therapy manufacturing.

• Maintain a continuous state of readiness for FDA, EMA, and other global health authority inspections, as well as client audits.

• Ensure alignment with applicable regulations, including 21 CFR Parts 210/211, 1271, EU GMP (Annex 1 & 2), ICH guidelines, and global regulatory expectations for advanced therapies.

• Collaborate with Regulatory Affairs and the PMO to translate evolving regulatory and client expectations into actionable inspection readiness strategies, standards, and best practices.

Regulatory Inspections, Client Audits & Customer Assessments

• Serve as the front-room inspection lead for regulatory authority inspections and client audits.

• Lead and coordinate inspection and audit readiness activities, including mock inspections, readiness assessments, gap analyses, and SME coaching.

• Coordinate execution of inspections and audits, including inspection teams, war room operations, daily briefings, issue tracking, and executive updates.

• Lead the development and execution of inspection and audit responses, including FDA 483 observations, regulatory commitments, and client responses, ensuring consistency.

Quality Systems Interface & Continuous Improvement

• Partner with Quality Systems, Site Quality, and Technical Operations teams to ensure audit-ready performance.

• Analyze inspection and audit trends to identify systemic compliance risks and drive remediation and continuous improvement.

• Support inspection readiness for new site start-ups, facility expansions, technology transfers, and commercial launches.

Leadership, Influence & Collaboration

• Provide functional leadership and mentoring on inspection readiness to SMEs and site quality partners, fostering a culture of proactive compliance and inspection confidence.

• Align and influence stakeholders across Quality, Technical Operations, MSAT, Regulatory Affairs, and Program Management to drive inspection readiness initiatives.

• Serve as a trusted advisor to senior leadership on inspection risk, regulatory exposure, and readiness status.

• Champion a strong culture of quality and compliance, reinforcing consistent behaviors, decision-making, and regulatory interactions during audits and inspections.

Required Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Engineering, or a related field.

• 10+ years of progressive quality leadership experience in cell therapy, biotech, or biologics, with deep exposure to GMP operations.

• Strong expertise in cell therapy or ATMP manufacturing and in-depth knowledge of global GMP regulations (FDA, EMA, ICH, ROW).

• Proven track record in a CDMO environment managing multiple client programs and regulatory compliance requirements.

• Demonstrated leadership during regulatory inspections, including FDA inspections and 483 resolution.

• Excellent verbal and written communication skills, with the ability to articulate complex compliance topics to inspectors, clients, and executive leadership.

• Experience leading audit and inspection planning, execution, and response activities.

• Willingness to work flexible hours, including evenings, weekends, and shift-based schedules as needed.

• Strong organizational skills with the ability to prioritize and manage multiple demands while maintaining a solution-oriented mindset.

Preferred Qualifications

• Experience supporting multiple clients simultaneously within a CDMO.

• Direct experience with pre-approval inspections (PAIs), BLA/MAA readiness, or commercial launch inspections.

• Experience supporting rapid-growth organizations, new site start-ups, or late-stage to commercial transitions.

• Lean, Six Sigma, or quality excellence certifications.

Educational Requirement

• B.S. in Life Sciences, Engineering, or related discipline required; advanced degree preferred.

Physical Requirements

• Ability to perform essential job functions in compliance with company standards, including productivity and attendance.

• Willingness to work in various controlled environments, including CNC/ISO7–8 cleanrooms.

• Ability to lift up to 25 lbs and perform physical tasks such as bending, standing, and working with cell-based products or chemicals.

• Must be flexible and adaptable to changing priorities and dynamic environments.

Company Description

Ambio is a specialty pharmaceutical company developing biosimilar, bioequivalent, and other complex generic drugs. Ambio has built a robust pipeline, executed partnerships with leading pharmaceutical companies, and established proprietary know-how and technological advances in peptide drug development and manufacturing. Starting in 2024, Ambio’s advanced pipeline will deliver commercial launches of several biosimilar drugs targeting blockbuster indications over the next few years. Furthermore, we are developing more complex drugs biosimilar to existing biologics and peptide drugs in the therapeutic areas of diabetes, obesity, and beyond..

Role Description

This is a full-time, on-site role for a Quality Assurance Manager located in Grovetown, GA. The Quality Assurance Manager will oversee the development, implementation, and monitoring of quality assurance systems and processes. Responsibilities include ensuring compliance with industry regulations, conducting quality audits, managing risk assessments, and addressing quality-related issues. The role also involves leading continuous improvement initiatives, overseeing documentation, and collaborating with cross-functional teams to maintain product quality and operational standards. The role actively participates in all the FDA related PAI preparation onsite and at the CMOs/CDMOs as required.

Qualifications

• Fundamental knowledge of drug product compliance principles
• 5+years experience in the pharmaceutical industry, in a QA role
• Experience in quality assurance processes, compliance monitoring, and quality audits
• Proficient in the use of Microsoft (Access, Excel, Word)
• Proficiency in quality documentation and reporting

A well-established, FDA-regulated pharmaceutical manufacturing organization is seeking a Director of Quality to lead all Quality Assurance and Quality Control operations at its U.S. production site. This is a high-impact leadership opportunity to own and govern the full cGMP Quality Management System across both liquid and solid dose manufacturing in a commercial environment.

This role is ideal for a seasoned pharmaceutical quality leader who wants true authority, autonomy, and executive partnership within a stable, vertically integrated manufacturing organization.

The Opportunity

You will serve as the final authority for batch record review and product release, overseeing the integrity of the entire quality system in compliance with 21 CFR 210/211. Reporting directly to executive leadership, you will ensure inspection readiness, sustained compliance, and operational excellence across QA and QC.

This is a hands-on leadership role where your decisions directly protect product quality, patient safety, and regulatory standing.

What You Will Own

• Design, implement, and maintain a fully compliant cGMP Quality Management System
• Final decision authority on batch record review and commercial product release
• Oversight of deviations, investigations, CAPAs, change control, and complaint handling
• Regulatory inspection leadership (PAI, routine, and for-cause)
• Governance of third-party contractors and laboratories
• Establishment and audit of procedures, specifications, and manufacturing controls
• Executive-level risk reporting and quality performance metrics

You will lead a team of approximately 25–30 quality professionals (QA and QC), including multiple managers and laboratory staff.

What We’re Looking For

• 10+ years of pharmaceutical manufacturing quality leadership experience
• Direct experience in commercial pharmaceutical production (not medical device or food)
• Deep expertise in 21 CFR 210/211 and FDA regulatory expectations
• Proven authority over final batch release decisions
• Experience leading FDA inspections and responding to regulatory observations
• Demonstrated oversight of deviations, CAPAs, investigations, and complaint systems
• Strong cross-functional leadership skills and executive communication ability
• Bachelor’s degree in Chemistry, Biology, or related discipline

This role requires someone who can operate independently, maintain regulatory integrity, and collaborate effectively with operations and scientific leadership.

About the Organization

• FDA-regulated manufacturing site operating since 1946
• Vertically integrated producer of liquid and solid dose medications
• One of the largest producers of liquid antacid products in the U.S.
• Approximately 100 employees
• 132,000-square-foot manufacturing facility
• Long-term ownership and stable operational history

The plant is located in Gulfport, Mississippi, approximately:

• 5 miles from the beach
• 1 hour from Mobile
• 1.5 hours from New Orleans
• Low cost of living with strong military and industrial presence in the region

Compensation & Benefits

• Base salary $120,000 – $150,000+ (flexible for the right candidate)
• Relocation support available
• PTO plus additional paid holidays
• Approximately 22 additional annual paid holiday closures
• Medical, Dental, Vision, Disability, and supplemental plans available

Interview Process

• Brief HR screen
• Executive virtual interview
• Onsite interview
• Offer

BlinkRx is the world’s first pharma-to-patient cloud that offers a digital concierge service for patients who are prescribed branded medications. Patients benefit from transparent low prices, free home delivery, and world-class support on this first-of-its-kind centralized platform. With BlinkRx, never again will a patient show up at the pharmacy only to discover that they can’t afford their medication, their doctor needs to fill out a form for them, or the pharmacy doesn’t have the medication in stock.

We are a highly collaborative team of builders and operators who invent new ways of working in an industry that historically has resisted innovation. Join us!

Responsibilities:

• Receive inbound phone calls to resolve routine and new issues with patients, doctors and insurers
• Provide patient care to accurately support pharma programs and triage to appropriate teams when required
• Strive to meet and exceed structured performance targets.
• Document all call information and data discovery according to operating procedures
• Utilize Knowledge Base materials as a foundation for resolving inquiries
• Maintain confidentiality of patient and proprietary information
• Develop a working knowledge of company related security and privacy practices.
• Participate in continued education on product changes, new features and product launches
• Help improve the patient experience by sharing feedback with management to further develop the product, materials and processes

Requirements:

• High school diploma or GED required, Bachelor’s degree strongly preferred
• Customer service or inbound call center experience required
• Healthcare, pharmacy or other relevant industry experience strongly preferred
• Strong verbal and written communication skills
• Sound technical skills, analytical ability, good judgment, and strong operational focus
• A passion for providing top-notch patient care
• Ability to work with peers in a team effort and cross-functionally
• Strong technical aptitude and ability to learn complex new software

Location/Hours

• Full time position hourly, on-site 5 Penn Center Blvd, Robinson Township, Pittsburgh, PA
• Availability for Monday-Friday : 10AM- 6PM, 11 AM- 7 PM, 12 PM - 8 PM OR 1 PM- 9 PM EST
• OR open for availability for 4 day 10 hour shifts from 11am-9 pm EST OR 10am-8pm EST
• Availability for rotating Saturday shifts 9am-5pm
• Scheduling flexibility, as your schedule may change over time according to business needs

Benefits

• Medical, dental, and vision insurance plans that fit your needs
• 401(k) retirement plan
• Daily meal stipend for onsite marketplace
• Pre-tax transit benefits and free onsite parking
• Free shuttle service