Pharma Jobs in Usa

The Sr. Project Engineer will support manufacturing operations with the introduction of new processing, packaging or facility fixed capital assets. Identify, develop and implement process improvements. They will also serve as a technical resource for designing and implementing technical solutions. Accountable for timely delivery of project engineering deliverables in a multi-functional environment. This could involve the relocation and optimization of the existing fixed asset base and/or the purchase of new fixed assets.

Essential Duties and Key Responsibilities:

• Managing capital projects from initiation to delivery utilizing engineering project management processes and procedures
• Adhering to regulations, industry best practices, and company engineering standards.
• Ensuring the successful completion of all project phases; Initiating, Planning, Executing, Controlling, & Closing.
• Develop and manage Resource Plans throughout the project lifetime.
• Develop and manage Communication Plans with all stakeholders throughout the lifetime of the project.
• Develop and manage Budget & Cost plans throughout the project lifetime.
• Providing technical solutions, design support, and equipment troubleshooting assistance to operations.
• Recommending and implementing continuous improvement projects and developing the necessary justifications and return on investment to drive these improvements.
• Developing knowledge mastery in new systems to train and coach plant engineers and maintenance staff with thorough transfer of knowledge and documentations.
• Ability to multi-task and work in a fast-paced and dynamic manner with quick response to change of direction.
• Proposing and implementing work processes, procedures and technical resources in accordance with the Engineering Policy.

Qualifications:

• BS Degree in Mechanical, Chemical, or Electrical.
• Minimum 8 - 10 years Project Engineering or Management Experience in a fast-paced manufacturing setting with experience in Food & Beverage, or Pharma manufacturing.
• Strong experience in capital project management utilizing standards and projects delivery through Initiation, planning, and execution.
• Skilled in developing DQ, FAT, CQV, Ramp up analysis, and other project management protocols.
• PE or SrPE, plus PMP certification preferred.
• Proficient in MS Office especially Excel and Microsoft Project, and ability to use CAD to develop and edit system designs and machine layouts. Ability to read electrical schematics, P&ID, construction drawings, and other technical documents.
• Demonstrated successful experience in a beverage, aseptic and/or food manufacturing environment.
• Understanding of financial analysis, relevant business KPI's and CAPEX budgeting preparation and tracking within approved budgets.

Position: Associate Director, Clinical Quality Compliance

Location: Bedford, MA (On-site 3 days/week)

Length: 6 Month Contract

Please no agencies. Direct employees currently authorized to work in the United States – no sponsorship available.

Job Description:

The Associate Director, Clinical Quality Compliance will be a primary quality contact for GCP and GCLP compliance. This person will support the clinical study teams towards ensuring compliance with global regulations (e.g., FDA, EMA, etc.) and will be required to contribute to developing the right strategies for the design and execution of all clinical and bioanalytical studies. This person will be responsible for establishing our clients inspections management program for GCP inspections and expected to be influential towards maturing the quality culture and help reach a sustained state of inspection readiness. This person will contribute to and execute the Clinical Quality Management Plan for compliance and risk monitoring for all the clinical studies. This person is required to contribute to establishing a scalable Quality Management System that is always ready for inspection. This role requires the person to identify and effectively communicate compliance risks and assist with developing sound strategies and drive action plans to mitigate risks.

Essential Duties and Responsibilities:

• Contribute to the development and maintenance of procedures for the GCP/ GCLP managed activities.
• Partner closely with members of the Clinical Development team to support the successful and compliant execution of clinical studies to meet regulatory requirements, guidelines, internal policies, and procedures.
• Develop and maintain integrated data-driven risk-based quality management plans to monitor the health of compliance.
• Participate in the development of GCP/GLP auditing strategies.
• Support investigations into scientific misconduct and/or serious breach of GCP. Partner with CROs and the clinical study team to analyze investigation findings to identify root/probable cause. Ensure adequate investigation, documentation, and implementation of appropriate CAPAs. Assure timely reporting of potential or confirmed violations, as appropriate, to regulatory agencies.
• Provide GCP compliance interpretation, consultation, training, and other supportive services necessary to maintain and improve the quality of research for timely regulatory submissions.
• Establish the GCP inspection preparation program and facilitate mock PAI inspections as necessary.

Qualifications:

• BS/BA, MS or PhD and a minimum of 10 years’ experience, respectively, in Biotech, Pharma or CRO.
• Working knowledge of relevant FDA, EU, ICH GCP / GCLP regulations and guidelines.
• Proficient auditing skills with the ability to identify risks based on objective evidence and communicate findings in a sound and factual manner.
• Ability to work autonomously, effectively manage time and deliver results on time.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• Conflict resolution/management and negotiation skills.
• Ability to manage multiple projects in a fast-paced environment.
• Excellent organizational, interpersonal, verbal, and written communication skills.

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.

Come see why DPC has achieved:

• 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.
• Voted ‘Best Staffing Firm to Temp/Contract For’ seven times by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.

As you are applying, please join us in fostering diversity, equity, and inclusion by completing the Invitation to Self-Identify form today!

# 18352

-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

The Director Quality Affairs is in charge of providing subject matter expertise on matters related to FDA regulatory compliance requirements, as well as leading the growth and responsibilities of the Quality Department. Responsible for maintaining the company’s Quality Management System’s (QMS). The Director represents the company in key stakeholder and strategy meetings on all quality matters related the company’s assets (development and manufacturing), including meetings with executive leadership, meetings with FDA and other regulators, and working with development and manufacturing partners. This role combines scientific, regulatory, and business knowledge to assure that products are developed within GXP compliance while meeting the company’s strategic goals.

Essential Duties and Responsibilities:

Quality

• Manages GXP quality activities.
• Builds on the company’s Quality Management System; formulates the company’s GMP, GLP and GCP compliance strategies and provides advice and support for clinical development programs.
• Oversee GMP, GLP and GCP compliance audits (US and international), including contract manufacturing sites, analytical testing sites, storage and distribution sites, contract test laboratories, and CROs to determine compliance status and to identify compliance risks.
• Oversee the QA reviews of GMP manufacturing and packaging batch records, product release and stability testing, validation reports, and essential clinical study documents.
• Assess all GMP compliance risks and develop and implement risk mitigation measures.
• Develops and implements standards, policies and procedures for GMP, GLP and GCP compliance.
• Partners with CMC, Clinical Development and Clinical Operations to ensure GMP, GLP and GCP compliance for all clinical development programs by providing guidance.
• Participates in the evaluation and selection of contract manufacturing sites, analytical testing sites, storage and distribution, CROs and other service providers used to support the clinical development programs.

Operations

• As the company grows, build a strong quality team to meet the needs of the business.
• Manage quality vendors.
• Develop and mentor quality staff/personnel.

Supervisory Responsibilities:

• Yes, in the future

Competencies:

To perform the job successfully, an individual should demonstrate the following competencies:

• Over 10 years of progressive advancement within GMP, GLP and GCP in the pharmaceutical /biotech industry.
• A thorough understanding of the drug development process along with knowledge of the developing regulations and guidelines.
• Ability to speak and interact with a diverse group of individuals on technical and business topics.
• Familiar with current regulatory legislation, industry trends, and health care business practices in the global arena.
• Highly developed organizational skills and project management skills with demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritization.
• Strong presentation, written and verbal communication skills; a clear communicator who can influence stakeholders effectively, both internally and externally.
• Proven ability to lead and manage complex global projects to successful completion.
• Flexibility/agility to respond to Renew’s evolving business needs.
• Strong ability to influence and gain credibility with both internal and external key stakeholders.
• Ability to manage in a consensus environment through teamwork, trust and shared expectations, influencing strategic direction of complex Quality issues, solicit information, listen well, persuade others, make important decisions and shape outcomes.
• Ability to build collaborative relationships both internally and externally.
• Ability to inspire, motivate and develop regulatory and quality teams.
• Ability to prioritize and handle multiple projects simultaneously.
• Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with scientists, managers, peers, and staff.

Education and/or Experience:

• BS/BA degree or equivalent (background in life sciences preferred). Advanced degree preferred.
• 10 +yrs. of industry experience (biotech/pharma/ CRO) with at least 8 years of QA experience
• Experience in ANDA and NDA FDA inspections (sponsor, vendor and sites)
• Strong understanding of ICH, GMP, GCP and relevant regulatory requirements
• Strong operations and management skills with attention to detail
• Excellent communication skills and proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project

Equal opportunity employer

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.

Job Purpose

Responsible for the execution of all aspects of solid-dosage manufacturing which includes, but is not limited to, the dispensing, granulation, sifting, milling, drying, encapsulation, coating, compression, and cleaning related activities. Must be able to interact daily with all site support personnel as required. Must be able to complete all required batch record documentation in a thorough, accurate, and legible manner in English. Must be capable of reading and understanding all documented Standard Operating Procedures in English plus demonstrate competency through action and written evaluation.

Essential Duties and Responsibilities include the following. Other duties may be assigned:

• Assist Production Management with all scheduled and requested activities in an efficient and smooth operation.
• Ensure all scheduled commercial and non-commercial manufacturing activities are completed on time.
• Become proficient in the setup, operation, and cleaning of all cGMP equipment used during production operations.
• Participate in all Quality Investigations as required.
• Adhere to all approved Standard Operating Procedures, Batch Records, and Safety Procedures as written when performing all daily activities.
• Ensure the cGMP area is cleaned and maintained following all SOP’s and good housekeeping practices.
• Must use required PPE during cGMP activities as specified in the Batch Records and Safety Data Sheets.

To perform this job successfully, an individual should have:

• Familiarity with working in a regulated pharmaceutical solid dosage facility.
• Ability to read and write documents written in English.
• Excellent written communication skills.
• Familiarity with various cGMP solid dosage Pharmaceutical manufacturing equipment. Able to setup, operate clean, and troubleshoot the solid dosage Pharmaceutical manufacturing equipment being used.
• Able to work with minimal supervision.
• Able to stand on feet throughout an eight-hour work day.
• Able to lift up to 30 Ibs (14 Kgs) without assistance.
• Maintain personal hygiene habits consistent with working in a cGMP environment
• Be capable of wearing all required PPE; including partial and full facepieces based on OSHA guidelines.

Education :

High School Diploma or GED Equivalent.

Bachelor’s degree in Physical Sciences or Pharmaceutical life science related field of study.

Years of related experience

2-8 years related experience in cGMP production operation activities.

Must have Valid work permit.

Position Overview

The Vice President of Business Development is responsible for driving new business growth and strategic partnerships for the agency. This role leads the identification, pursuit, and acquisition of new pharmaceutical, biotech, and healthcare clients while strengthening the agency’s market presence and revenue pipeline. The VP will report to the CEO and collaborate with executive leadership, strategy, and creative teams to develop compelling solutions that address client needs and support long-term agency growth.

NOTE: Candidates in the TriState Area (NJ/NYC/Local PA) are highly preferred.

Key Responsibilities

Business Growth & Revenue Generation

• Identify, pursue, and secure new client opportunities across pharmaceutical, biotech, and healthcare sectors
• Develop and manage a robust pipeline of prospective clients and partnerships
• Lead RFI/RFP responses and pitch development with cross-functional teams
• Meet or exceed annual revenue and new business targets

Client Acquisition & Relationship Building

• Build and maintain relationships with senior marketing and commercial leaders within pharma and life sciences organizations
• Represent the agency at industry conferences, networking events, and client meetings
• Develop long-term strategic partnerships that generate sustainable revenue growth

Strategic Leadership

• Partner with executive leadership to define growth strategy and priority target accounts
• Provide market intelligence on industry trends, client needs, and competitive positioning
• Collaborate with strategy, creative, medical, and account teams to shape compelling client solutions

Pitch & Proposal Leadership

• Lead the development of pitch strategies and storytelling that highlight the agency’s capabilities
• Coordinate internal teams to produce high-impact presentations and proposals
• Guide contract negotiations and onboarding of new clients

Market Development

• Identify emerging opportunities in digital health, biotech launches, patient engagement, and omnichannel marketing
• Strengthen the agency’s reputation within the healthcare marketing ecosystem

Qualifications

• 5+ years of business development, sales, or client growth experience in pharmaceutical, biotech, or healthcare marketing/advertising
• Proven track record of winning and growing multi-million-dollar client relationships
• Deep understanding of the pharma commercialization and marketing landscape
• Experience leading agency pitches and RFP processes
• Strong executive presence and relationship-building skills
• Excellent presentation, negotiation, and strategic thinking abilities
• Bachelor’s degree required; MBA or advanced degree preferred

Key Success Metrics

• Annual new business revenue generated
• Number and quality of new client relationships established
• Pitch win rate and pipeline growth
• Strategic partnerships developed within the pharma ecosystem

We offer a competitive compensation package, health benefits/perks, discretionary annual bonus, 401(k) plan with 50% match, and opportunities for growth.

NPG Health is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

Sr. Quality Control & Sample Management Specialist

Our client is looking for an experienced QC and sample management professional to support high‑quality data generation within our Translational DMPK and Clinical Pharmacology team. This role ensures accuracy, compliance, and smooth sample lifecycle management across internal and external studies.

Responsibilities

• QC review of bioanalytical data (LC‑MS/MS, ELISA, qPCR) and study documentation from internal teams and CROs
• Manage and review scientific documents in SharePoint
• Format internal reports and provide templates to CROs
• QC review of packing slips, manifests, and critical reagent documentation
• Contribute to drafting and editing bioanalytical lab guidelines
• Routine QC of Electronic Lab Notebooks
• Audit finalized reports and maintain errata
• Use LIMS (LabVantage) for sample receipt, tracking, aliquoting, storage, shipping, and disposal

Requirements

• Bachelor’s degree in a scientific or healthcare field
• 5+ years QC experience in pharma, biotech, or CRO environments
• Proficiency with LIMS (LabVantage preferred) and electronic notebooks
• Strong understanding of GxP regulations
• Excellent attention to detail, communication, and organizational skills
• Proficiency in Microsoft Word, Excel, and PowerPoint
• Familiarity with bioanalytical assays is a plus

About

is the premier career networking resource for the Pharmaceutical, Biotechnology, and Medical Device industries. We are looking for a highly organized Sales & Event Operations Coordinator to provide critical administrative support to our sales team and manage the logistical "heavy lifting" for our industry-leading career fairs and events.

The Role

This is a high-impact administrative role designed for a detail-oriented professional who loves organization. You will not be responsible for making sales; instead, you will be the backbone of the department—ensuring that once a sale is made, the client is onboarded perfectly and the event logistics are executed flawlessly.

Key Responsibilities

Event & Logistics Support:

• Vendor Management: Coordinate with venues and vendors for catering & decorating.
• Exhibitor Onboarding: Send "Welcome" kits to registered companies, collect their logos/bios, and ensure they have everything they need for event day.
• Onsite Support: Serve as the "Command Center" during live events—managing check-ins, distributing badges, and assisting exhibitors with booth setup.
• Materials Management: Maintain and organize event supplies, marketing collateral, and shipping logistics for regional shows.

Sales & Administrative Operations:

• Contract Administration: Prepare and send out sales agreements and invoices following client commitments.
• CRM Maintenance: Keep our client database (CRM) up to date, ensuring all contact information and deal statuses are accurate.
• Reporting: Generate weekly reports for management on event registration numbers and sales pipeline progress.
• Lead Management: Organically route incoming inquiries to the sales team and manage the general info@ email account.

Qualifications

• Organization: You have a "black belt" in multitasking and never let a deadline slip through the cracks.
• Experience: 2+ years in an administrative, office management, or coordinator role.
• Communication: Professional and polished; you will be interacting with HR leaders from some of the world’s largest pharma companies.
• Software Skills: Proficiency in Microsoft Office (Excel is a must), CRM platforms, and ideally some familiarity with event software like Eventbrite or Cvent.
• Location: Must be able to work onsite daily at our Piscataway, NJ office.

Why ?

• Stable, Fast-Paced Environment: A professional office setting within the heart of the New Jersey life sciences corridor.
• Impact: You’ll see the direct results of your work as thousands of professionals find jobs through the events you help build.
• Team Focus: You are the essential partner to our sales and leadership teams.

$40K Salary

About the Company:

Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion Healthcare, which suggested a new growth model in the Korean biopharmaceutical industry through biosimilars, is now advancing to new challenges to become a global pharmaceutical provider. Just as it has overcome many obstacles in the past, Celltrion Healthcare will successfully pave the path for global direct selling, which has never been achieved yet by Korean biopharmaceutical companies. As it continues to surpass its current success, Celltrion Healthcare will take a leap forward to become a leading global biopharmaceutical company.

Celltrion Healthcare provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world.

POSITION SUMMARY

The Contractor will provide operational and analytical support for commercial contracts, pricing execution, and logistics operations under the guidance of the Sr. Director, Pricing and Contracting. This role focuses on enhancing team operational efficiency through accurate data processing and meticulous execution of tactical tasks.

KEY ROLES AND RESPONSIBILITIES

• Contract & Pricing Support

Maintain and update the Commercial Pricing Master File to ensure all approved prices are accurately reflected in internal systems.

Support the drafting and administrative review of commercial contracts, including organizing supporting exhibits and pricing addendums.

• GTN (Gross-to-Net) support

Consolidate monthly/quarterly raw data for rebates and chargebacks from multiple stakeholders for financial accuracy.

Conduct primary data validation using Excel functions to flag outliers or calculation errors before final settlement.

• Operational Reporting & Data Management

Aggregate sales and pricing data to generate standardized weekly/monthly performance reports for management review.

Manage and improve Excel-based tracking tools to streamline data consolidation and enhance reporting accuracy.

• Tactical Execution & Departmental Coordination

Follow up on specific action items from internal meetings and ensure all administrative deliverables are completed on schedule.

Liaise with relevant departments (Finance, Sales, Supply Chain, etc) to gather necessary data for urgent pricing or logistics inquiries.

WORK EXPERIENCE

• 1–3 years of experience in Pharma/Biotech or related fields (Sales Support, Finance, Logistics).
• Experience in data-heavy administrative tasks and contract support.

QUALIFICATIONS

• Advanced Excel Skills (Required): Proficiency in VLOOKUP, Pivot Tables, and data organization.
• Meticulousness: Strong attention to detail in data entry and document review.
• Communication: Ability to clearly understand requests and coordinate effectively with relevant departments.
• Bilingual, Korean preferred.

EDUCATION

• Bachelor’s Degree required in business or related field; advanced degrees, MBA, MS in business or related field is a plus.

CORE COMPETENCIES

• Analytical Rigor: Ability to process and validate large datasets with high accuracy using advanced Excel skills.
• Operational Excellence: Strong attention to detail in managing contract documentation and meeting strict deadlines.
• Collaborative Mindset: Effective communication skills to coordinate seamlessly with Finance, Sales, and Logistics teams.
• Adaptability: A flexible approach to supporting diverse tactical tasks within a fast-paced commercial environment.

Celltrion USA is an equal opportunity employer. It is our policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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