Ascendis Pharma Jobs in Usa

IQVIA is a leading global provider of research and development, commercial solutions, and technology-enabled services to the life sciences industry. We help customers accelerate innovation and improve patient outcomes by combining deep scientific expertise with advanced data assets, transformative technology, and integrated services. IQVIA Digital builds on this foundation to deliver omnichannel engagement strategies powered by privacy-optimized data, advanced analytics, and scalable technology, enabling pharmaceutical companies to connect with healthcare professionals and patients in meaningful, measurable ways.

The Pharma Segment Lead defines and drives IQVIA Digital's segment-level strategy for pharmaceutical clients. This role sets the vision for how we position our capabilities and value proposition, ensuring alignment with client needs and market trends. The Pharma Segment Lead combines strategic thinking with hands-on storytelling, creating compelling narratives and resources that enable sales, marketing, and product teams to win and grow business. The role is accountable for measurable commercial outcomes and plays a critical part in IQVIA Digital's continued growth trajectory.

Segment Strategy:

• Develop and own the segment strategy for IQVIA Digital offerings across large pharma and other prioritized segments, including key accounts and EBP (pre-commercial, small, and mid-sized pharma).
• Identify growth opportunities, prioritize products and solutions, and influence product development roadmaps to address gaps.
• Participate in strategic forums such as product summits to pressure-test ideas and ensure alignment with market needs.
• Monitor market trends, competitive dynamics, and customer needs to inform strategy and scenario planning.

Strategic Storytelling:

• Craft and adapt executive-ready narratives that articulate IQVIA Digital's vision, capabilities, and proof points, tailored by segment and therapeutic area (oncology, rare disease, immunology, cardiometabolic).
• Build clear, concise, and compelling presentations for client innovation days and senior-level engagements.

Collaboration & Client Engagement:

• Lead planning for client innovation days and strategic meetings, partnering with Sales and Product to define objectives, storyboards, and partnership opportunities.
• Serve as a commercial strategy SME in high-level pharma client meetings and innovation days.
• Support Sales in key strategic meetings by co-leading preparation and delivery of material.
• Collaborate with Marketing and Thought Leadership teams to shape and amplify IQVIA Digital's points of view, ensuring consistency across external engagements.

Commercial Enablement:

• Package offerings for lead generation and sales enablement, ensuring resources are current and aligned with GTM priorities.
• Contribute to strategic account reviews and cross-functional initiatives to integrate IQVIA Digital solutions into broader offerings.

Partner Strategy & Innovation:

• Contribute to GTM partner strategy including leading evaluation, recommendation, and implementation of partners.
• Identify emerging technologies or partnerships that could enhance IQVIA Digital's value proposition.

Customer Experience & Data-Driven Insights:

• Champion a customer-centric approach to solution design and engagement.
• Leverage data and analytics to inform strategy and track performance.

- 10+ years in pharmaceutical brand and/or marketing roles; agency experience strongly preferred.

- Management consulting experience in life sciences or healthcare strategy is highly desirable.

- Recognized industry presence through publications, speaking engagements, or thought leadership contributions.

- Proven ability to develop and deliver strategic narratives and executive-ready presentations.

- Deep understanding of pharma customer needs across functions and market trends shaping future requirements.

- Experience across major therapeutic areas (oncology, rare disease, immunology, cardiometabolic).

- Exceptional skills in strategic thinking, storytelling, slide design, and cross-functional collaboration.

Approximately 5% (one trip per quarter for client meetings or industry events).

To be eligible for this position, you must reside in the same country where the job is located.

IQVIA is proud to be 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, disability, status as a protected veteran, or any other status protected by applicable law.

The potential base pay range for this role, when annualized, is $121,400.00 - $338,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

Role: Senior Product Owner – Pharma Commercial Analytics

Location: South San Francisco, CA

Role Summary:

We are seeking a seasoned Product Owner to lead the vision, strategy, and execution of our Commercial Analytics portfolio. You will be the bridge between our Sales/Marketing business units and the Data Science/Engineering teams. Your goal is to transform raw commercial data into actionable insights that drive sales force effectiveness, optimize marketing spend, and improve Healthcare Professional (HCP) engagement.

Worked on Sales and Marketing side...like created sales and marketing a document; created or worked on market strategy, worked on pricing starategy and market research...

Done any utilization analytics.

Key Responsibilities:

1. Product Vision & Backlog Management

• Define the roadmap for commercial data products, sales dashboards, and predictive analytics models.
• Translate complex business requirements from Marketing and Sales leaders into technical user stories for the engineering team.
• Prioritize the product backlog based on business value, ROI, and commercial impact.

2. Pharma Commercial Domain Leadership

• Oversee the integration of industry-standard data sources (e.g., IQVIA, Symphony, Veeva CRM, Specialty Pharmacy feeds).
• Optimize analytics for Sales Force Effectiveness (SFE), including territory alignment, incentive compensation, and call planning.
• Drive the data strategy for Omnichannel Marketing, ensuring seamless tracking of HCP touchpoints across digital, email, and face-to-face channels.

3. Data & Analytics Program Oversight

• Lead the delivery of advanced analytics programs, such as Next Best Action (NBA) engines, patient journey mapping, and marketing mix modeling (MMM).
• Ensure data integrity and compliance with healthcare regulations (e.g., HIPAA, GDPR, Sunshine Act).
• Collaborate with Data Architects to ensure the commercial data lake/warehouse is scalable and supports real-time reporting.

Required Qualifications

• Experience: 5–8+ years of Product Owner or Product Management experience, specifically within the Life Sciences or Pharmaceutical sector.
• Domain Expertise: Deep understanding of the Pharma Commercial lifecycle (Market Access, Brand Management, Field Sales, and Patient Services).
• Technical Literacy: Proven experience running data-heavy programs. Familiarity with SQL, Snowflake/AWS data environments, and visualization tools (Tableau/Power BI).
• CRM Knowledge: Hands-on experience with Veeva CRM or Salesforce Health Cloud.
• Education: Bachelor's degree in business, Data Science, or a related field (MBA or MS in Analytics preferred).

FleishmanHillard is a global integrated communications agency delivering transformational outcomes for some of the world’s biggest brands. We have an immediate opening for an Account Supervisor or Managing Supervisor with a background in and a passion for Health & Life Science (H&LS) communications to work with collaborative teams on integrated programs encompassing media and influencer relations, brand messaging, paid media integrations/sponsored content, social media, and more within the pharmaceutical space. FH has built its reputation on creating customized, integrated solutions that deliver what our clients value most: meaningful, positive and measurable impact on the performance of their organizations meeting their specific challenges or opportunities. We’re seeking energetic professionals with good instincts, who are early adopters and self-starters, and have an adventurous spirit and passion for collaboration. Our culture values talented, nimble, creative people who are both exemplary leaders and effective team players.

FleishmanHillard values the importance of impact and inclusion to strengthen the bonds between us, grow our people and create spaces for everyone to thrive. We stay true to our commitment to our people and the communities in which we live and work. As part of our ongoing effort to be the world’s most inclusive agency, we are committed to seeking candidates who possess and demonstrate a profound interest in furthering our impact and inclusion goals.

Responsibilities

• Develop and execute strategies for national health media for campaigns, products/services and compelling trend stories. Must have strong relationships with health/pharma lifestyle media along with experience targeting different demographics, with an emphasis on HCPs and patient audiences.
• Support the execution of high-quality campaign launches alongside opportunistic media programs, helping manage from conception to execution to placement.
• Assist in managing a series of paid editorial partnerships focused on sponsored content, helping to identify, vet and RFP partners, along with overseeing brief, content development and contractual needs.
• Partner with internal stakeholders to collaborate on integration of paid partnership social media assets, with an understanding of platform requirements and best practices within a regulated environment.
• Work with senior members across the network to manage and execute integrated communications programs that embrace all areas of communications including product PR, branding, social media management, crisis/issues management, and media relations.
• Play a pivotal role in handling many of the day-to-day deliverables for the H&LS practice’s account teams, including content creation and oversight as well as project and account management.
• Drive story idea development and work closely with media to shape and control communications that are in line with overall account objectives.
• Work with integrated teams to provide clients with seamless multi-channel solutions utilizing traditional PR, digital and social media platforms to deliver maximum performance and results.

Qualifications

• A minimum of 4+ years of experience in developing and implementing communications programs, with an emphasis on public relations work for large pharma and public sector clients. Agency experience is strongly preferred.
• Experience managing paid product integrations, media partnerships or brand sponsorships with a focus on producing sponsored content, with an understanding of the process from RFP to AAR, and all points in between. Demonstrated ability to manage deal points and contracting process and integration of partnerships into owned social media channels
• Understanding of and passion for media, content, and creative and the details that go into taking a partnership concept from ideation, to implementation, and finally to market in a variety of forms – online, broadcast and social
• Energetic, self-starter and resourceful problem solver – gets things moving and keeps them on track. High attention to detail with the ability to manage multiple ongoing activities.
• Depth of well-rounded experience in the H&LS practice area, with proven success working with a variety of top-tier health long-lead publications, short-lead health media and national broadcast media, including national morning shows. A demonstrated hands-on media approach is required.
• Experience managing and coordinating projects with multiple work streams, including managing more junior team members, both directly and indirectly.
• Excellent writing abilities with extensive experience developing and editing high quality written materials, including media correspondence and story angles; and illustrating strong presentation skills.
• The ability to develop and generate support for strategic, comprehensive communications plans that apply creative tactics and use a variety of communication channels, including digital (e-mail, social media, blogs and intranet), print publications and brochures, executive memos, face-to-face meeting scripts/talking points, special events, video, and FAQs.
• Ability to illustrate a results-focused approach and commitment to going the extra mile for clients. Experience working directly with clients on day-to-day activities.
• Good interpersonal skills, can work effectively in a virtual team environment, negotiate approvals diplomatically, and maintain composure and quality under deadlines in a fast-paced environment.

FleishmanHillard specializes in public relations, reputation management, public affairs, brand marketing, digital strategy, social engagement and content strategy. FleishmanHillard was named 2020, 2021 and 2022 Campaign Global PR Agency of the Year; 2023 ICCO Large Agency of the Year – The Americas; 2022 and 2023 PRWeek U.S. Agency of the Year; 2022 and 2023 PRWeek U.S. Outstanding Extra-Large Agency of the Year; 2023 Campaign US PR Agency of the Year; 2021 PRovoke APAC Consultancy of the Year; and 2021 PRWeek UK Large Consultancy of the Year. FleishmanHillard is part of Omnicom PR Group and has nearly 80 offices in more than 30 countries, plus affiliates in 45 countries.

FleishmanHillard offers a hybrid work model and seeks employees who are comfortable working in the office for a portion of their week, in accordance with their local office hybrid work policy. We value the collaboration and camaraderie that in-person interactions provide, but also understand the importance of flexibility and balance in our employees’ lives. We acknowledge that our people are diverse individuals with unique circumstances and needs, and therefore our goal is to foster a productive and inclusive work environment where all employees can thrive, both in and out of the office.

FleishmanHillard is an Equal Opportunity and Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sex stereotyping, pregnancy (which includes pregnancy, childbirth, and medical conditions related to pregnancy, childbirth, or breastfeeding), gender, gender identity, gender expression, national origin, age, mental or physical disability, ancestry, medical condition, marital status, military or veteran status, alienage, citizenship status, sexual orientation, genetic information, or any other protected class under federal, state or local laws. Please do not contact the office directly to apply – only resumes submitted through this website will be considered. If you need assistance reviewing career opportunities or completing an application, please email our careers team or call 314-982-1700 and ask to be connected to Talent Development.

The anticipated U.S. salary range for Account Supervisor level is $61,000.00 - $94,000.00.

The anticipated U.S. salary range for Managing Supervisor level is $71,000.00 to $125,000.00.

Salary is based on a range of factors that include relevant experience, knowledge, skills, other job-related qualifications and geography. A range of medical, dental, vision, 401(k) matching, paid time off and/or other benefits also are available.

Job Title - Training Coordinator - Pharma Operations

Location - Easton PA

The Training Coordinator is responsible for the strategic coordination, compliance oversight, and administrative management of the employee development program within pharmaceutical operations or GMP‑regulated training. The Training Coordinator role require candidates with GMP‑regulated experience in a pharmaceutical setting. This role ensures training activities are aligned with operational demands, properly resourced, and fully compliant with company policies, OSHA standards, client requirements, and regulatory expectations. The training coordinator will maintain an audit-ready workforce ensuring employees are compliant and up to date on training records.

MUST HAVES -

• Direct experience maintaining training records in an LMS - need for accurate, audit‑ready training documentation.
• Demonstrated history of developing and delivering internal training in pharma & life sciences, as well as supporting SOP and job aid updates in regulated environments.
• Extensive experience in highly regulated FDA/GMP environments, supporting complaint management, audits, and compliance activities.
• Strong reporting skills, including trending, KPI analysis, and preparing audit‑ready materials.
• experience in warehouse‑specific training logistics, such as WMS familiarity, multi‑shift training calendars, and training around warehouse equipment certification (e.g., PIT/Forklift).
• experience with OJT verification workflows or tracking certifications/expiration dates tied to warehouse operations.
• troubleshooting classroom technology (e.g., handheld scanners or tablets used in training).

Education & Experience

• High school diploma or equivalent
• 2+ years of administrative and training coordinator experience, specifically within a background related to pharmaceutical operations or GMP‑regulated training. candidates with GMP‑regulated experience in a pharmaceutical setting.

Responsibilities:

• Develop and maintain comprehensive training schedules across all warehouse departments.
• Support facilitation of training on company policies, SOPs, safety standards, and operational systems (e.g., LMS, WMS/C3).
• Partner with warehouse leadership to ensure structured training programs are consistently executed for new hires and existing associates.

Logistics & Scheduling

• Training calendar coordination: Manage the master training calendar across 1st, 2nd, and 3rd shifts, ensuring training sessions do not disrupt peak shipping and receiving windows.
• Onboarding Logistics: Coordinate onboarding training for new associates, including safety gear (PPE) distribution, badge access, and classroom setup.
• Equipment Certification: Schedule and track practical evaluations and certifications for Powered Industrial Trucks (PIT) and other applicable equipment, ensuring only authorized personnel operate machinery.

Administrative & LMS Management

• Record Integrity: Maintain the training program within the Quality Management System and any required physical training documentation, ensuring every associate has a complete, accurate, and audit-ready training profile.
• Compliance Tracking: Proactively monitor certification and qualification expiration dates (e.g., PIT/Forklift, HazMat, Safety protocols) to prevent compliance gaps or operational disruption.
• SOP Document Control: Coordinate distribution and version control of Standard Operating Procedures (SOPs) to ensure associates are trained on current, approved processes.

Reporting & Auditing

• Audit Support: Prepare and present training documentation during internal audits, client audits, OSHA inspections, and regulatory reviews.
• Productivity Reporting: Generate reports on training completion rates and "Time to Productivity" for new hires to help Operations plan for peak seasons.
• OJT Verification: Collect, verify, and maintain On-the-Job Training (OJT) documentation to confirm hands-on competency validation by authorized supervisors.

Technical Skills:

• Advanced proficiency in Microsoft Office (Excel is critical for tracking metrics). Experience with Quality Management Systems and/or Warehouse Management Systems is a plus.
• Organization: Exceptional organizational skills with a "zero-error" approach to data entry, understanding that a missing record can lead to a regulatory finding.
• Communication: Ability to communicate clearly within a diverse workforce, from entry-level associates to senior facility management.
• Experience with "Train-the-Trainer" models in a manual labor setting.
• Ability to troubleshoot basic classroom technology (tablets, hand-held scanners used for training).
• Effective analytical, problem solving and decision-making skills (can gather and analyze data and information and draw conclusions). Able to think logically and analytically.
• Able to prioritize, organize tasks and time, and follow up. Performs responsibilities efficiently and timely. Able to balance multiple requests and meet deadlines.
• Able to work well in a team environment and as part of a team.
• Demonstrates ability to effectively lead a team to successful completion of a project.
• Knowledge of FDA and CFR requirements surrounding training

Location: 2 days onsite in Hunterdon County, NJ

Salary: $80-110K

Account Manager, Pharma Market Access

Account & Client Management

• Serve as day-to-day client lead for major pharmaceutical accounts, ensuring exceptional service and long-term relationship development.
• Lead and facilitate weekly status meetings, capturing actions, aligning stakeholders, and driving deliverables forward.
• Act as a strategic partner, proactively identifying client needs and offering solutions that align with business goals.

Project & Workflow Management

• Oversee projects from intake to delivery—ensuring scope clarity, milestone tracking, and flawless execution.
• Manage timelines, budgets, resource allocation, and delivery expectations.
• Ensure all content and materials move through appropriate review and approval workflows within Veeva Vault.

Cross-Functional Collaboration

• Partner with creative, medical, strategy, and production teams to ensure integrated delivery.
• Communicate priorities clearly and ensure consistent alignment across all workstreams.
• Support quality control across all assets and deliverables.

Business Growth & Opportunity Development

• Identify and activate new opportunities within existing accounts (expanded scopes, new initiatives, or service offerings).
• Support proposal development, SOW creation, and forecasting.
• Contribute to account planning and client roadmap development.

Regulatory & Submission

• Manage workflows for regulatory submission materials, including FDA/OPDP and internal MLR review processes.
• Partner closely with cross-functional regulatory, medical, and legal teams to ensure timely review cycles.
• Guide clients and internal teams on submission strategy, timelines, and requirements.

Required Skills & Experience

• 5–7+ years of account management experience within a life sciences/healthcare communications agency.
• Proven ability to run client status meetings, maintain project momentum, and manage multiple concurrent initiatives.
• Exceptional written and verbal communication skills; comfortable interacting with senior client stakeholders.
• Strong project management skills: timeline development, scope management, and problem-solving.
• Experience supporting or growing existing client business.
• Understanding of regulatory submissions, MLR processes, and medical/regulatory content requirements.
• Hands-on experience working within Veeva Vault

Preferred Qualifications

• Experience in patient support and/or market access or advocacy experience.

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.

Aseptic Fill/Finish | Pharmaceutical Manufacturing | Sterile Injectables

Weekend Day Shift -> Friday - Sunday from 6am to 6pm (10% Shift Differential) (2 openings)

Weekend Night Shift -> Friday - Sunday from 6pm to 6am (15% Shift Differential) (2 openings)

Full-Time, Direct Hire with Full Benefits

A pharmaceutical manufacturing organization is seeking an Equipment Specialist to support sterile drug product manufacturing operations. This hands-on role is responsible for operating, troubleshooting, and maintaining production equipment used in aseptic fill/finish processes. This individual will play a key role in supporting manufacturing operations by ensuring equipment is properly prepared, operating efficiently, and meeting GMP quality standards. The position will also assist with equipment improvements, troubleshooting, and technical support for the production team.

Key Responsibilities

• Set up, operate, and perform changeovers on pharmaceutical production equipment (changeovers are a requirement)
• Support batch start-up activities and execution of manufacturing cycles
• Perform work within controlled manufacturing environments including cleanrooms (Grade A and Grade C)
• Execute aseptic operations within isolator systems when required
• Document manufacturing activities and complete batch records in accordance with cGMP requirements
• Assist with equipment troubleshooting, repairs, and preventative maintenance
• Support validation runs, engineering batches, and equipment qualification activities
• Serve as a technical resource for filling equipment and related manufacturing systems
• Train manufacturing staff on equipment operation and production procedures
• Participate in process improvements and equipment optimization initiatives
• Work with engineering, operations, and quality teams to resolve production issues and maintain operational efficiency

Basic Qualifications

• High school diploma or equivalent required
• Approximately 7+ years of experience working with GMP pharmaceutical manufacturing equipment
• Hands-on experience installing, operating, cleaning, and maintaining production equipment in a regulated environment
• Strong mechanical aptitude and troubleshooting abilities
• Proficiency with basic computer systems (Microsoft Office or similar tools)

Preferred Background

• Bachelor’s Degree in a Science related discipline
• Experience supporting aseptic or sterile injectable fill/finish manufacturing processes
• Working knowledge of cGMP standards and pharmaceutical manufacturing operations
• Familiarity with SAP/ERP, inventory, or manufacturing systems
• Strong communication skills and ability to support cross-functional teams

Work Environment

• Pharmaceutical manufacturing facility supporting sterile drug product production
• Cleanroom and controlled production areas (Grade A and Grade C)
• Weekend manufacturing schedule supporting critical production operations

• AOR experience
• Launch experience
• HCP & Patient experience
• Bachelor’s degree or equivalent education plus professional experience required
• Approximately 10+ years of client services, agency, digital pharmaceutical, and healthcare-related experience required
• Subject matter expert for digital, media and technology marketing and advertising, including new product launches
• Ability to maintain revenue results from developed strategic marketing campaigns
• Proven leader in fast-paced, agile work environments
• Ability to excel while wearing many hats; comfortable with making fast decisions
• Excels at leading large teams and has the ability to serve as a leader to cross-functional project teams across the organization
• Exceptional coaching and mentoring skills
• Ability to negotiate contract and work assignments
• Creative thinker with analytical skills
  
  

Key Responsibilities

• Manage and maintain the Quality Management System (QMS).
• Lead CAPA, deviations, investigations, and change control processes.
• Ensure compliance with GMP, cGMP, and GDP standards.
• Provide quality oversight for clinical packaging, labeling, storage, and distribution.
• Support FDA inspections, audits, and regulatory compliance activities.
• Maintain SOPs, quality documentation, and quality metrics.
• Collaborate with cross-functional teams across warehouse and clinical supply operations.

Requirements

• 5+ years of QMS experience in the pharmaceutical industry.
• Mandatory experience in CAPA, GMP, and cGMP environments.
• Knowledge of GDP regulations and quality systems.
• Experience with clinical packaging & labeling under 21 CFR 210/211.
• Experience supporting FDA inspections or audits is a plus.
• Familiarity with SAP and MS Office.

Aseptic Fill/Finish | Liquid Drug Product

Weekend Day Shift -> Friday - Sunday from 6am to 6pm (2 openings)

Weekend Night Shift -> Friday - Sunday from 6pm to 6am (2 openings)

Full-time, Direct Hire with Full Benefits

A pharmaceutical manufacturing organization is seeking a Formulation Specialist to support bulk drug product preparation within an aseptic sterile fill/finish environment. This hands-on role is responsible for formulation, equipment operation, and cGMP manufacturing activities supporting aseptic production.

The position works closely with manufacturing, quality, and technical teams to ensure safe, compliant, and efficient batch execution while contributing to process improvements and operational excellence.

Key Responsibilities

• Perform weighing, dispensing, and formulation activities for liquid drug product manufacturing
• Set up, operate, clean, and maintain formulation and processing equipment
• Execute manufacturing operations within controlled and cleanroom environments
• Complete batch documentation and manufacturing records in accordance with cGMP requirements
• Support aseptic filling operations and equipment preparation as needed
• Assist with validation runs, engineering batches, and process troubleshooting
• Train and support team members on manufacturing procedures and best practices
• Participate in continuous improvement and equipment optimization initiatives
• Collaborate cross-functionally to ensure production timelines and quality standards are met

Basic Qualifications

• High school diploma or equivalent required
• Minimum 1+ year of GMP pharmaceutical manufacturing experience or 3+ years of related manufacturing experience
• Experience operating and maintaining production equipment in a regulated environment
• Basic computer proficiency (Microsoft Office and similar systems)

Preferred Background

• Bachelor's Degree with a Scientific focus (not required)
• Experience in sterile or aseptic pharmaceutical manufacturing environments
• Knowledge of cGMP regulations and good documentation practices
• Familiarity with SAP/ERP or inventory management systems
• Strong communication skills and attention to detail

Work Environment

• Pharmaceutical manufacturing facility supporting sterile drug product production
• Cleanroom and controlled manufacturing areas required (Grade A and Grade C)
• Hands-on production role with weekend schedule coverage