Engineering Structures Jobs in Princeton

Our team members are the heart of what makes us better. At Hackensack Meridian Health we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It’s also about how we support one another and how we show up for our community. Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.

Carrier Clinic, a behavioral health system, has been a trusted source of compassionate help and supportive healing for patients and their families since we opened our doors in 1910.

Hackensack Meridian Health Carrier Clinic’s East Mountain Youth Lodge provides a continuum of out of home residential treatment services for adolescents between the ages of 13-18. We provide 24 hour clinical, therapeutic treatment for emotional, behavioral, psychiatric and substance abuse difficulties based on the resident strengths and needs.

1. Directly supervises and knows the whereabouts of every resident they are assigned. 2. Supervises, observes, and participates with residents in the carrying out of the daily routine (i.e. chores). Consistently implements all program procedures (i.e. point systems, level systems).

3. Runs activity, support and recreation groups with guidance from clinical staff. Organizes, supervises and conducts planned activities for groups and individuals. Provides assistance to residents in the planning of appropriate recreational activities.

4. Serves as a primary counselor for an assigned number of residents.

5. Assists residents in learning home management skills (cooking, cleaning, etc). Teaches residents about the importance of cleanliness, good nutrition, meal planning, prudent buying, etc., while guiding them in learning skill mastery.

6. Corrects client behavior by administering reasonable and fair disciplinary measures when necessary. Ensures each resident is informed of the rules and regulations of the program.

7. Provides crisis intervention to residents as needed. Assists in escorts and personal restraints of agitated residents. Attentive to building security and performs such checks as designed by the program.

8. Conducts resident room checks and room searches as designed by the program.

9. Carries a beeper for one week in rotation. Is on-call and ready to respond to staff shortages by calling and locating a replacement and/or filling the shift him/herself.

10. Inspects and handles belongings and valuables of residents to ensure that prohibited material is not brought into the Lodge at admission, upon return from pass, or as clinically indicated, under the direction of a Shift Leader.

11. Assists residents with daily living activities (i.e.; waking up, hygiene, cleaning room, participating in structure, behaving appropriately on activity).

12. Provides input to administration members regarding unit-based PI measures based on concerns, high risk, high volume issues.

13. Ensures that paperwork is completed accurately and within procedural time limits. 14. Other duties and/or projects as assigned.

15. Adheres to HMH Organizational competencies and standards of behavior.

Education, Knowledge, Skills and Abilities Required:

• Co-Occurring (Wolf), RTC (Eagle, Butterfly) Will have one of the following qualifications: (1) High School diploma, general equivalency diploma (GED), and/or GED equivalent programs with one year of experience working with youth in a group setting. (2) An Associate's or Bachelor's Degree from an accredited college or university in a field that is unrelated to social work or psychology with six months of experience working with youth in a group setting. (3) An Associate's or Bachelor's Degree from an accredited college or university in social work, psychology, or a related field.
• PCH (Lotus, Sunflower) Bachelor's Degree or High School diploma, general equivalency diploma (GED), and/or GED equivalent programs, with three or more years of experience providing direct care to youth in a behavioral health agency or institutional setting
• IRTS Level of Care (Swan) Bachelor's Degree, or equivalent, with one year of experience providing direct care to youth in a behavioral health agency or institutional setting.
• Complete Shift Leader and Medication Administration training.
• Maintains standards of confidentiality
• Excellent written and verbal communication skills.
• Proficient computer skills that may include but are not limited to Microsoft Office and/or Google Suite platforms.

Licenses and Certifications Required:

• Valid Driver's License from a USA state within 3 years of entering position. 

If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!

Company Description

Venus et Fleur is a luxury rose atelier renowned for its meticulously handcrafted arrangements of real roses that maintain their freshness for over a year. Inspired by Parisian design, our roses are delivered in elegant keepsake boxes, creating a modern and luxurious gifting experience. Every arrangement is customized to customers’ specifications, offering a stunning array of patterns, letters, symbols, and an extensive color palette. Dedicated to artistry and innovation, our team ensures each exquisitely curated order reflects the highest standards of design and beauty.

Position Overview

The Inbound & Inventory Supervisor owns inbound execution, warehouse-controlled inventory accuracy, material availability, and warehouse standards. This role supervises 1–2 Inventory / Receiving Clerks and serves as the operational link between Supply Chain, Logistics, and Production to ensure clean material flow into and out of the warehouse.

This role is accountable for all inventory accuracy from dock receipt through warehouse storage and staged release to production. Once inventory is formally transferred to Production, ownership shifts.

In this business, small gaps create lost revenue. This role exists to eliminate those gaps inside the warehouse while ensuring safe handling, storage, and movement of all materials.

Leadership & Team Oversight

• Supervise and develop 1–2 Inventory / Receiving Clerks
• Set daily priorities for receiving, putaway, counts, replenishment, and staging
• Audit work for accuracy and scanning compliance
• Coach for detail, urgency, and disciplined execution
• Enforce SOP adherence across Receiving, Putaway, Picking, and Transfer to Production
• Hold team accountable for warehouse inventory standards

Inbound Management & Quality Control

• Lead receiving operations for florals, vessels, packaging, and consumables
• Validate quantities against POs prior to system receipt
• Inspect florals for quality and specification compliance
• Ensure lot tracking accuracy for florals
• Quarantine and resolve non-conforming materials
• Document and escalate vendor discrepancies within 24–48 hours
• Coordinate dock flow and inbound prioritization
• Ensure accurate labeling, LPN creation, and system transactions

Warehouse Inventory Accuracy & Control

• Maintain 98–99%+ accuracy for all warehouse-controlled inventory
• Design and execute A/B/C cycle count programs
• Lead daily cycle counts and reconciliation
• Perform documented root cause analysis on variances
• Identify recurring drivers of shrink within warehouse operations
• Implement corrective and preventative controls
• Monitor aging, at-risk, and space-constrained inventory

Cross-Functional & Logistics Coordination

• Partner with Logistics to understand inbound schedules, lead times, and container arrivals
• Align with Supply Chain on POs, forecasts, and inbound prioritization
• Anticipate space constraints based on inbound pipeline
• Adjust labor focus and urgency based on inbound risk
• Communicate material arrival timing and constraints to Production
• Escalate inbound delays that may affect service levels

Material Release & Production Interface

• Ensure accurate staging and system transfer of materials to Production
• Maintain clear physical and system boundaries between warehouse and production inventory
• Prevent undocumented movement of materials
• Support investigations of production-related discrepancies while maintaining ownership boundaries

Warehouse Standards & Safety

• Maintain a clean, structured, luxury-grade warehouse environment
• Ensure proper storage conditions for florals and packaging
• Enforce safe material handling practices and adherence to all warehouse safety procedures
• Identify and address safety risks related to storage, material movement, and equipment use
• Promote a proactive safety culture where hazards are reported and corrected immediately

KPIs

• 98–99%+ warehouse inventory accuracy
• 100% cycle count completion
• Zero preventable warehouse-driven stock-outs
• Inbound discrepancy resolution within 48 hours
• Reduction in warehouse-related shrink
• 100% lot traceability for florals within warehouse control
• Team scanning compliance > 99%

Qualifications

• 3–5+ years in inventory control or warehouse supervision
• Experience supervising small teams
• Strong WMS/ERP experience with lot tracking
• Experience coordinating with Logistics and Supply Chain
• Strong root cause and process control mindset
• Demonstrated continuous improvement mindset with the ability to identify process gaps and implement practical operational improvements
• Detail-driven, disciplined operator

Onward Search Education is a specialized education staffing and talent solutions company that helps educators, therapists, and school health professionals find top jobs with the nation’s top schools. We’re partnering with a school program in Mercer County, New Jersey to hire a dedicated Speech-Language Pathologist (SLP) for the 2025–2026 school year.

The Speech-Language Pathologist (SLP) will provide comprehensive speech and language services to students with autism in a specialized school setting. The SLP will assess communication needs, deliver evidence-based therapy, and collaborate with a multidisciplinary team to support functional communication, social language, and academic success. This role is ideal for clinicians passionate about working with students with autism in a structured, supportive environment.

Position Details:

• Position: Speech-Language Pathologist (SLP)
• Location: In-person, Mercer County, NJ
• Setting: Specialized autism school (non-adult program)
• Schedule: Full-time or part-time; specific days/hours are flexible
• School Calendar: Year-round program
• School Year: 2025–2026
• Start Date: ASAP

Responsibilities:

• Conduct speech and language evaluations and screenings for students with autism.
• Provide direct therapy services in individual and small-group settings.
• Develop, implement, and monitor IEP goals related to speech, language, and communication.
• Support functional communication, social language, and AAC use as appropriate.
• Collaborate with teachers, behavior specialists, and related service providers to ensure consistent supports.
• Maintain accurate documentation, progress notes, and compliance with IDEA and state requirements.

Qualifications:

• Valid New Jersey Speech-Language Pathologist license (required).
• Experience working with students with autism preferred.
• Knowledge of AAC systems, pragmatic language interventions, and evidence-based practices.
• Strong collaboration and communication skills within multidisciplinary teams.
• Commitment to student-centered, inclusive, and data-driven practice.

What We Offer:

• Competitive pay and benefits package.
• Access to a wide network of schools and districts for diverse placement options.
• Streamlined hiring process to get you started quickly.
• Ongoing communication and advocacy throughout your placement.
• Personalized support from dedicated recruiting professionals.
• Opportunities for professional growth and development.

Why Apply?

If you’re passionate about supporting students with autism and making a meaningful impact in a specialized, year-round school environment, this is the opportunity for you! Join a collaborative team dedicated to helping students build communication skills that support independence and success.

Ready to join us? Apply today – we can’t wait to hear from you!

Location: Hamilton, NJ
Start Date: ASAP
Duration: Ongoing
Setting: Onsite Only
Trauma Level: Low

Schedule:

• Monday to Friday
• 8:00 AM 5:00 PM
• No call required

Case Volume & Daily Breakdown:

• Total cases: (can flex up to 100)
• 4 fluoroscopy (primarily modified barium swallow studies)
• 30 X-rays
• 20 Ultrasounds
• 10 CTs
• 10 MRIs
• No mammography or procedures

Support Structure:

• Onsite radiologist supported by remote radiologists
• Remote team covers all ED and inpatient reads
• Onsite locum focuses on outpatient reads and basic fluoroscopy

EMR: Epic

Since 1933, Stark & Stark has developed innovative legal solutions to meet our client's needs. With experienced attorneys in more than 30 practice areas, and a philosophy of putting the law to work for our clients is the basis for building and maintaining our practice.

The candidate will work on purchase and sale transactions from inception through closing, including drafting and negotiating primary and ancillary documents for M&A and similar transactions and documentation of entity formation and equity sharing arrangements. Advise clients on business structures, compliance issues, and strategic planning. Conduct due diligence on corporate, financial, and regulatory matters to identify risks and opportunities. Prepare legal opinions and memoranda on transactional and corporate matters. The candidate will work closely with other attorneys and paralegals, correspond and communicate with clients’ business and legal personnel, and coordinate with attorneys across other practice disciplines.

Qualifications

• 5-7 years of practice experience required.

• Exceptional interpersonal, drafting, negotiation, written and verbal communication skills.

• Excellent organizational skills with high level of attention to detail and accuracy.

• The right candidate is an analytical thinker with a business mind.

• Strong knowledge of contract law, corporate governance, and M&A transactions.

• Demonstrated ability to work as part of a team and to interact directly with clients.

• Admission in New Jersey is required. Admission in Pennsylvania or New York is bonus.

Benefits

Stark & Stark is committed to the health and well-being of its staff members. The firm offers a full range of benefits, including traditional major medical and hospitalization coverage, a prescription plan, a dental plan, a vision plan, life insurance, accidental death, and dismemberment coverage, a profit sharing, and a 401(k) plan, paid vacation, and paid holidays.

Mansfield Rule

As part of its continued efforts to actively recruit and advance the recruitment, development, and promotion of diverse lawyers Stark & Stark is participating in Diversity Lab’s Midsize Mansfield Rule initiative. The Mansfield Rule is named for Arabella Mansfield, the first woman admitted to practice law in the United States. It measures whether law firms affirmatively consider diverse lawyers for hiring, advancement, and significant leadership roles.

Under this initiative, we strive for a candidate pool consisting of at least 30% women, attorneys from underrepresented racial and/or ethnic groups, lawyers with disabilities, and/or LGBTQ+ attorneys. The Mansfield Rule initiative also includes a commitment by Stark & Stark to be transparent in our internal governance, particularly with our selection guidelines and job descriptions for firm management roles and committees.

Status: Full Time, Non-Exempt

Reports to: Chief Development Officer

New Jersey League of Conservation Voters (New Jersey LCV) is a bi‐partisan, non‐profit organization that protects our precious natural resources by raising awareness of key environmental challenges; increasing the efficacy of the environmental community; helping elect environmentally responsible candidates to state and local offices, advocating for strong environmental policies, and ensuring accountability to safeguard the health of our communities, the beauty of our state, and the strength of our economy.

We are committed to and incorporate into all our work, the goal of helping establish a just, inclusive, and

equitable environmental future for New Jersey. We work with, learn from, and support overburdened and low-income communities to educate the public, co‐create social change, and advocate for environmentally just policies.

Currently we are looking for a Development and Strategic Content (Associate up to Manager) to work in our collaborative environment, supporting a robust and growing grassroots fundraising program. This role will focus on supporting the Chief Development Officer and Development team with our fundraising strategies, as well as with a split focus on grant writing and digital fundraising that supports our family of organizations and political action committees. The ideal candidate will thrive in a fast-paced, energetic organization that juggles a lot of demands while working cross-organizationally with a strong, supportive team. They must be able to work independently, as well as with a dynamic Executive Director and committed Board of Directors to maximize outcomes. This position offers the opportunity for a person passionate about the environment to work with a leading conservation organization that is making a significant, positive difference in our State.

RESPONSIBILITIES

Grant Management

• Support and manage grant fundraising efforts for New Jersey LCV/New Jersey LCV Education Fund, including new grants and renewals of existing funding:
• o Write compelling one-year and multi-year grant proposals, telling meaningful "stories", including research data that supports the request, while aligning funder's criteria with New Jersey LCV/EF needs and programmatic strengths.
• o Expand the funder portfolio for grant requests by researching and identifying new institutional funders whose priorities align with New Jersey LCV/EF missions, programs and goals.
• o Demonstrate a high degree of skill in communication and positive interaction as a liaison between foundations and New Jersey LCV staff.

• Work with the Operations team to oversee and support grant management processes, ensuring all paperwork and payment tracking is managed in an effective and timely manner.
• Work proactively across teams to coordinate all programmatic and fiscal reporting requirements and deadlines as stipulated in grant documents.
• Oversee the comprehensive management of EveryAction, the organization's grant tracking system, to ensure accurate and timely monitoring and reporting of funding by source.

Strategic Development & Digital Content

• Write, edit, and coordinate fundraising-specific content across channels with creation of impactful storytelling that brings creativity and a donor-centered lens to all written communication.
• Collaborate with the Development and Communications teams to grow a creative digital outreach program by planning, executing, and evaluating performance of new digital fundraising campaigns, ensuring content aligns with organizational goals, brand, and strategy.
• Oversee the coordination and publication of the organization's Annual Report, including drafting and ensuring accurate content, managing timelines, and collaborating with teams and designers.
• Support the Chief Development Officer's major giving and high-capacity donor efforts ($10,000–$25,000+), including donor research, prospecting, and creating supporting materials.
• Provide general support across the department, as needed and assigned; including department and organization-wide fundraising strategic planning, content calendars, and campaign execution.
• Other duties as assigned.

QUALIFICATIONS

• At least 2-3 years previous nonprofit fundraising, grant writing or related experience, with a proven track record of working successfully with individuals, corporations and foundations; digital outreach experience a plus
• Commitment to our vision, mission and values, including increasing and integrating racial diversity, justice and equity into our work and organizational culture.
• Strong written, oral and digital communication skills, with a customer service focus.
• Skilled in persuasive and effective writing, with the ability to write a convincing case for support.
• Close attention to detail and ability to manage multiple projects and meet deadlines.
• Ability to work effectively with diverse teams and ranges of people, including volunteers and donors.
• A self-starter, comfortable in a team environment with colleagues in office and remote locations.
• Ability to travel for staff meetings, events, conferences and donor meetings.
• Experience with Microsoft office and donor management software preferred.

POSITION REQUIREMENTS: This is a full-time position with a hybrid work structure based in Hamilton, NJ and remotely. Travel throughout the State is necessary so a valid driver's license and continuous, real-time access to a car are required. The ability to maintain a flexible schedule common to fundraising is required.

SALARY: $40,000 - $55,000 depending upon experience and level of position for which candidate qualifies. Ranges are based on an external and organizational wage analysis, noting that new staff rarely start at the top of a range; and a very comprehensive benefits package.

To apply: Please send your resume, cover letter, and salary requirements to with "Development and Strategic Content" in the subject line. No calls please.

New Jersey LCV is an equal opportunity employer. We are committed to creating a diverse environment and is proud to be an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin or ancestry, genetics, disability, age, marital status, familial status, domestic partnership status, civil union status, pregnancy, atypical hereditary cellular or blood trait status, or veteran status.

Java Developer

Must have Java + Spring Boot

DESCRIPTION:

Job Responsibilities:

● Develop applications using Java 8/JEE (and higher), Angular 2+, React.js, SQL, Spring, HTML5, CSS, JavaScript and TypeScript among other tools.

● Write scalable, secure, maintainable code that powers our clients' platforms. ● Create, deploy and maintain automated system tests.

● Works with Testers to understand defects opened and resolves them in a timely manner ● Support continuous improvement by investigating alternatives and technologies and presenting these for architectural review

● Collaborates effectively with other team members to accomplish shared user story and sprint goals

Requirement:

● Experience in a programming language Java and JavaScript

● Decent understanding of the software development life cycle

● Basic programming skills using object-oriented programming (OOP) languages with in-depth knowledge of common APIs and data structures like Collections, Maps, lists, Sets etc.

● Knowledge of relational databases (e.g. SQL Server, Oracle) basic SQL query language skills

Preferred Qualifications:

● Master's Degree in Computer Science (CS)

● 0-1 year of practical experience in Java coding

● Experience using Spring, Maven and Angular frameworks, HTML, CSS ● Knowledge with other contemporary Java technologies (e.g. Weblogic, RabbitMQ, Tomcat, etc.) · Knowledge of JSP, J2EE, and JDBC

Company Overview:

Luye Pharma is fast-growing pharmaceutical company committed to advancing innovative therapies for Central Nervous System (CNS) disorders, with a primary focus on schizophrenia. Our pipeline includes promising new treatments such as Erzofri and Rykindo, which are set to launch in the U.S. market.

Position Summary:

In this role, you will collaborate closely with the US Head of Commercial Operations to design, implement, and manage data analytics and performance reporting systems. Your main responsibility will be to provide actionable insights that support decision-making and drive improvements in commercial outcomes. As the Manager of Commercial Analytics, you will serve as a key analytics partner for commercial leaders across sales, marketing, and operations in the US. You will offer valuable insights and recommendations to fuel growth, optimize field performance, and analyze market and patient trends. Additional key responsibilities include developing reporting processes and assisting with the coordination of Monthly Business Reviews, focusing on KPIs, forecasting variances, and updates to the Latest Estimate.

Report to: Head of Commercial Operation

Key Responsibilites:

• Develop and maintain performance dashboards and reports, integrating internal KPIs and external datasets to track business metrics, monitor progress toward sales goals, and evaluate operational performance.
• Conduct in-depth analysis of market trends and product performance to identify growth opportunities and risks.
• Evaluate overall business performance, including volume, market share, new patient starts, and KPIs, comparing actuals against forecasts and targets.
• Partner with Sales and Commercial Leadership to optimize territory alignments, call planning, and customer targeting, using analytical insights to improve sales coverage and operational efficiency.
• Assess performance and activity trends at sub-national levels to uncover opportunities, inefficiencies, and areas for improvement within the sales force.
• Prepare monthly business reviews, utilizing a combination of third-party market data (e.g., prescriber, chargebacks, 867, 852 data) and internal performance metrics to guide executive decision-making.
• Build and maintain performance dashboards and reports by integrating internal KPIs and third-party datasets to monitor business metrics, track progress against sales goals, and evaluate operational performance.
• Assist in designing incentive compensation structures and performance metrics, including goal setting and attainment analysis.
• Analyze market trends, physician and account-level data, and promotional effectiveness to support segmentation, targeting, and brand strategy.
• Provide support to field teams by addressing data and reporting requests, resolving inquiries, and delivering actionable insights for daily execution.
• Collaborate with cross-functional teams to develop demand forecast models.
• Conduct data analysis, reporting, and generate actionable insights to support commercial brand strategy and execution.
• Other duties as assigned.

Qualifications:

• Bachelor’s degree
• 3-5 years of experience in relevant analytics roles within the pharmaceutical or life sciences industry.
• Strong understanding of the pharmaceutical industry and familiarity with third-party data sources (e.g., Symphony Health, IQVIA, etc.).
• Strong proficiency in Excel
• Exceptional analytical capabilities, including the ability to manipulate large data sets and apply advanced analytical methodologies.
• Experience with BI tools (Tableau, Power BI, Qlik etc.) preferred.

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

BW Electric is seeking a BIM Coordinator to join our organization. This position is to assist in the creation, evaluation, and distribution of 3D BIM and 2D drawings for use in estimating, purchasing, and construction operations. The BIM Coordinator will assist all project managers and field personnel to facilitate collaboration and communication throughout the project, and interact with subcontractors, vendors, and the design team during construction. In addition to working in a fast-paced environment, the BIM Coordinator will have primary responsibility for assigned projects, as CAD Operator/Project Engineer. Candidates must be able to perform essential field Coordinating tasks and have strong capabilities with AutoCAD, AutoCAD MEP, Navisworks, and BIM 360, with working knowledge of Revit, and related programs.

General Responsibilities

• Has knowledge of and/or takes initiative to learn modeling software; including but not limited to Navisworks, Revit, and AutoCAD
• Maintain integration of models including structure, interior, and exterior architectural elements and MEP systems
• Coordinate with BIM service providers and/or Subcontractors
• Update As-built and revised BIM logs and reports; maintain BIM server folders
• Assist with uploading, maintain, and distributing documents to the field and subcontractors
• Assist in set-up and maintain all control logs (RFI’s, shop drawings, as-built, drawing logs, etc.) and shop/fabrication-level models for approval
• Site inspection and liaising with trade contractors
• Participate in model coordination and model coordination meetings.
• Compile contract BIM closeout documentation
• Works on complex assignments independently, with attention to detail, and a high degree of initiative to resolve issues; involves others in decisions when needed.

Minimum Requirements

• Associate degree in Civil, Electrical, Mechanical, Construction Management, Construction Technology, or equivalent experience.
• Minimum 2-4 years of project Coordination experience – intern field Coordinator, entry-level field Coordinator, or equivalent.
• Strong ability to read and understand plans and specifications.
• Minimum 2 years consistent use, and be able to demonstrate experience in required software (Revit, AutoCAD, Navisworks )

Job Type: Full-time

Pay: $65,000 - $110,000 - Commensurate with experience

Ability to Commute/Relocate:

· Hillsborough, NJ (Required)

Experience:

• AutoCAD,
• AutoCAD MEP
• Navisworks and
• Project Coordinating: 2 years (Required)

About the Role

The candidate will support technical documentation required for BLA submission, and ensure the QC organization is inspection ready. This position will also coordinate QC schedules, resource allocation, and testing timelines critical for successful BLA submission.

Responsibilities

• Support preparation and review of technical reports and QC documentation required for the BLA, ensuring timely completion and regulatory accuracy.
• Create, maintain, and monitor QC testing trackers, documenting tests, timelines, assigned analysts, sample workflows, and status updates.
• Facilitate and maintain a resource loading tracker, aligning personnel capacity with sample testing volume to ensure on-time data generation for the BLA.
• Escalate resource gaps, workflow delays, or testing challenges that could impact critical milestones.
• Support method transfer and method validation troubleshooting to ensure analytical readiness for BLA submission.
• Lead the establishment and maintenance of a stability program, ensuring data availability for regulatory filing.
• Participate in internal and external GMP audits, ensuring QC operations meet all regulatory expectations.

Required Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Biotechnology, Biology, required
• 5+ years of experience in an FDA-regulated pharmaceutical with demonstrated experience supporting major regulatory submissions (e.g., BLA, NDA, MAA).
• 5+ years of experience in analytical chemistry methods including HPLC, UPLC, GC, TOC, and related instrumentation.
• Strong working knowledge of USP/EP, cGMP, EU GMP, and analytical compliance requirements.
• Proven experience tracking testing deliverables, coordinating QC schedules

Preferred Skills

• Technical writing expertise, including investigations, method documents, validation protocols/reports, and change control assessments.
• Ability to prioritize multiple deliverables and manage time effectively in a high-pressure, deadline-driven environment, especially in support of regulatory filing timelines.