Jobs in Skillman, NJ

Job Title : Medical Assistant/Technician (Hospital Corpsman) Category / Component : Enlisted • Both Overview Hospital Corpsmen assist healthcare professionals and provide medical and dental care to Sailors, Marines, and their families across clinics, hospitals, ships, and field units, gaining broad clinical, technical, and operational experience.

Key Responsibilities Perform emergency medical treatment for Sailors, Marines, and specialized units such as SEALs and Seabees; provide basic and emergency dental care and process dental X rays; serve as operating room technician and assist in surgery; administer preventive care and medications including immunizations and IVs; conduct physical exams and assist in diagnosing and treating diseases and injuries; maintain patient records, perform clinical tests, and support physicians and nurses in a wide range of specialties.

What to Expect Hands on patient care with shift work and possible on call duties; field training and deployments with Marine and expeditionary units and embarked medical departments on ships; continuous certification and recertification in areas such as basic life support, trauma care, and tactical combat casualty care; mix of clinic, ward, and field environments with rapid response in emergent situations and a strong emphasis on teamwork and readiness.

Work Environment Assignments in Navy hospitals and clinics, aboard aircraft carriers and other ships, with Marine units in garrison and field environments, and occasionally on submarines; work in exam rooms, wards, operating rooms, emergency departments, aid stations, and field medical sites; close integration with medical teams, line units, and joint or coalition partners.

Pathways, Training & Advancement Recruit Training followed by Hospital Corpsman A School at Fort Sam Houston, Texas; numerous advanced C schools that lead to Navy Enlisted Classifications in areas such as Independent Duty Corpsman, Fleet Marine Force, preventive medicine, surgical technology, respiratory therapy, pharmacy, radiology, laboratory, dental, and dive medicine; progressive professional development through leadership courses and warfare qualifications such as Fleet Marine Force and Surface, Aviation, or Expeditionary pins where applicable.

Direct enlistment into the Hospital Corpsman rating from civilian life; in service conversion for qualified Sailors from other ratings who meet screening and performance criteria; Reserve accession for prior service Hospital Corpsmen and select civilian medical professionals when manning needs allow.

Qualifications All Navy jobs require meeting general enlistment or commissioning standards, which typically include: Eligibility to serve in the United States Navy, which may involve United States citizenship or other legal residency and work status, depending on the program and current law and policy A high school diploma or equivalent for enlisted positions, and a bachelor's or qualifying professional degree for officer positions Meeting age limits that vary by program and are set in law and Navy policy.

Some communities have more restrictive age ranges Meeting medical, vision, and dental standards, including body composition and physical fitness requirements, with some jobs requiring more demanding standards Meeting character and conduct standards, including background screening Achieving required test scores for your program, such as the Armed Services Vocational Aptitude Battery for enlisted roles or officer qualification tests for officer programs Eligibility for a security clearance when required for your rating or designator Additional qualifications can include specific skills, education, licensure, or experience that are unique to a job or community and will be reviewed with you by a recruiter.

Additional qualifications for this job may include: United States citizenship or equivalent status as allowed by policy; high school diploma or equivalent; at least 17 years of age; interest in healthcare and willingness to work in clinical and field environments, potentially under stressful conditions; ability to meet medical, vision, and physical fitness standards required for medical and operational assignments.

Education Education benefits are available through standard Navy programs such as Tuition Assistance, the Post-9/11 GI Bill, ACE-recommended college credit for Navy training, Navy COOL-funded certifications, USMAP apprenticeships, and other Navy College Program opportunities.

Specific options depend on the Sailor's status, training, and current Navy policy.

Pay, Benefits & Service Pay, benefits, and service commitments follow standard Navy Active and/or Reserve policies for this type of role, including basic pay, allowances when eligible, health coverage, and retirement options.

Exact entitlements, special pays, and service obligations depend on program, component, years of service, and current law and Navy guidance.

Incentives Incentives such as bonuses, special pays, and loan repayment may be available at times for specific ratings or communities, but they change frequently and cannot be guaranteed.

Applicants must confirm current incentives and eligibility with an official Navy recruiter or authoritative Navy source.

Notes and Disclaimers This description is a general overview of typical duties, training, and opportunities in this community.

It does not replace official Navy instructions, policies, or contracts and does not guarantee specific assignments, training, incentives, or outcomes.

Actual opportunities depend on Navy needs, individual performance, screening results, and current law and policy.

• Pioneer of Geriatric House Calls™ to older adults in their communities.
• Provide physical therapy services in a 1:1 setting to help abolish ageism.
• Drive rewarding patient outcomes.
• Facilitate clinically-excellent autonomous interventions.
• Benefit from the flexibility to create, control, and alter your treatment schedule.
• Be a part of an Interdisciplinary approach by a therapy team focused on functional outcomes.
  

• Full-time/Part-time – Salaried with benefits
• PRN/Flex – PPU (Paid Per Unit)
• H1B - Able to provide sponsorship to those who need it that are qualified
• New Grads-FOX offers a widely recognized Emerging Professionals Mentor Program!
  

• Clinical and non-clinical career growth opportunities
• Supportive Clinical Community
• Unlimited access to continuing education
• Professional Certification Reimbursement
• Access to cutting-edge technology
• Medical, Dental, Vision, 401k (for those who qualify)
  

• Valid Physical Therapy license in the state(s) of practice, or eligibility to apply
• Degree from an accredited physical therapy program
• Basic computer literacy skills
• Current CPR certification
  

At Aspen Dental, we put You First, offering the security and job stability that comes with working with a world-class dental service organization (DSO). Our best-in-class training program, competitive compensation, and flexible scheduling will help you thrive in your career. When you join our team as a Dental Office Manager, which at Aspen Dental we call an Operations Manager, you will have the opportunity to give back to communities and positively affect patients’ lives.

Job Type: Full - Time

Salary: $55000 - $65000 / year + monthly and quarterly incentive earnings **

At Aspen Dental, we put You First. We offer:

• A generous benefits package that includes paid time off, health, dental, vision, and 401(k) savings plan with match*
• Career development and growth opportunities to support you at every stage of your career
• A fun and supportive culture that encourages collaboration and innovation
• Free Continuous Learning through TAG U

How You’ll Make a Difference:

As a Dental Office Manager, you will lead the office in all office operations in support of the doctors to help create lasting impressions and build trust and loyalty with patients. When you join an Aspen Dental practice, you’ll participate in an extensive, ten-week training program to gain business and leadership knowledge designed to help you succeed and grow within our organization.

• Provide superior patient service with compassion and care in accordance with patient needs, company policies and procedures, government regulations, and dental board standards
• Hire, develop, manage and retain the office staff
• Consult with patients on treatment options provided by clinical team, verifying insurance payment and collection ensuring high quality of care
• Review monthly business results, manage profit and loss, align sales plan to support business goals and create strategies to increase profitability
• Prepare and lead daily huddles with team to level set expectations to optimize patient experience and business performance
• Additional tasks as required

Preferred Qualifications

• Minimum of one year of managing a team of direct reports
• High school diploma or equivalent; college degree is preferred
• A people centric leader who motivates and inspires others
• Strong communication and interpersonal skills, with the ability to build rapport with patients of all ages and backgrounds
• Demonstrate analytical thinking; place a premium on leveraging data

Aspen Dental-branded practices are independently owned and operated by licensed dentists. The practices receive non-clinical business support services from Aspen Dental Management, Inc., a dental support organization.

• May vary by independently owned and operated Aspen Dental locations.
• Limitations apply, please see recruiter for details

ADMI Corp., d/b/a TAG-The Aspen Group, its affiliates, related companies and independently owned supported clinical practices are proud to be Equal Opportunity Employers and welcome everyone to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

R2

Job Summary:

The Medical Promotional Review Specialist ensures the scientific accuracy, clinical appropriateness, and regulatory validity of promotional materials from a medical and scientific perspective. This role serves as a member of the Promotional Review Board (PRB), collaborating with cross-functional stakeholders including Marketing, Legal, Regulatory Affairs, and Medical Affairs. The specialist reviews promotional content, evaluates supporting scientific data, and provides recommendations to ensure compliance with approved labeling, regulations, and company policies while supporting safe and effective product use.

Key Responsibilities:

• Review promotional materials to ensure medical accuracy, scientific validity, and clinical appropriateness
• Verify alignment of promotional content with approved labeling, scientific evidence, regulations, and company policies
• Evaluate the appropriateness of data, references, and claims used in marketing materials
• Provide recommendations for alternative data, references, or language when needed
• Collaborate with PRB reviewers and commercial teams to address concerns related to promotional materials
• Engage with business partners early in promotional material development to improve efficiency
• Work with Medical Directors for assigned products or therapeutic areas to ensure alignment and mitigate risk
• Document review comments and verdicts within the PRB workflow system within assigned timelines
• Participate in Promotional Review Board meetings as required
• Stay current with medical literature and scientific data in assigned therapeutic areas
• Attend internal and external meetings and training related to regulations, scientific updates, and marketing strategy

Required Skills:

• Demonstrated expertise in reviewing medical literature and evaluating scientific validity of promotional content
• Ability to clearly and concisely communicate complex scientific information
• Proven ability to build and maintain collaborative cross-functional relationships
• Strong understanding of the US pharmaceutical industry, healthcare landscape, and promotional review compliance requirements
• Detail-oriented with strong editorial and analytical skills
• Strong organizational and prioritization abilities
• Ability to work effectively within cross-functional teams
• Ability to critically analyze and apply scientific data in a customer-focused manner
• Strong verbal and written communication skills
• Effective negotiation and influencing skills

Education:

• PharmD, MD, DO, or NP required
• Minimum 2 years of relevant professional experience (academic, clinical, or industry)
• Post-doctoral fellowship may substitute for professional experience where appropriate

Application Lab Technician-Fragrance/Perfumery (air or home care samples )

Plainsboro, NJ- Onsite

Duration: 6 Months+

Shift: 1st Shift: Start times between 7:30 - 8:30 am

Pay $25/hr. on w2

Must Have:

Helpful exp. in Fragrance but not required.

Someone that will be able to operate with minimal supervision.

Day to Day looks like:

Role Overview:

As an Application Lab Technician, your role will be to support the Application Labs and act as a liaison with our commercial teams by preparing air or home care samples in various technologies for internal evaluation, stability requests, and final customer submission. You will manage customer bases and documentation, and coordinate/communicate with our internal business partners.

The primary focus will be to support home and air care lab application work.

Qualifications for this role are as follows:

• Bachelor’s degree or equivalent degree/experience preferably in a concentration of Science along with a minimum of 1 year of practical laboratory experience.

• Previous experience in the fragrance industry strongly preferred

• Strong communication skills, attention to detail, and proactivity

• Excellent planning, organizational and time management skills with proficiency in MS Office Applications such as Word, Excel

• Self-starter, with strong sense of ownership, assertive and passionate for high level of client satisfaction

• Ability to work comfortably in a very fast paced environment with short project deadlines

Your key responsibilities:

• Prepare and deliver complex application samples for internal/external clients using our CLASS sampling system while adhering to delivery due dates and applying good laboratory practices

• Ensures all samples produced meet the quality standards as per the global SOPs before releasing the samples and identifies/flags any technical sampling issues

• Keeps and maintains application bases up to date and aligned with the collection in digital systems

• Keeps the personal workbench clean and organized as per the best practices

• Operates with a team spirit mindset and supports their colleagues under high workload situations

LTIMindtree is an equal opportunity employer that is committed to diversity in the workplace. Our employment decisions are made without regard to race, color, creed, religion, sex (including pregnancy, childbirth or related medical conditions), gender identity or expression, national origin, ancestry, age, family-care status, veteran status, marital status, civil union status, domestic partnership status, military service, handicap or disability or history of handicap or disability, genetic information, atypical hereditary cellular or blood trait, union affiliation, affectional or sexual orientation or preference, or any other characteristic protected by applicable federal, state, or local law, except where such considerations are bona fide occupational qualifications permitted by law.

A little about us...

Role: Oracle PL/SQL Developer

Location: Pennington, NJ

Job Description:

Responsibilities for PL/SQL developer

• Should have a good knowledge in Advanced PL/SQL.
• Should have exposure to Unix and shell scripting
• Exposure to debugging and troubleshooting is an added advantage
• Exposure to the financial domain is an added advantage
• Responsible for the design, development, coding, testing, debugging, and documentation of applications to satisfy the requirements of user areas
• May include hands-on new development support, maintenance, or enhancement of existing applications
• Commit to and actively work to remain knowledgeable in latest coding languages, database software, system, standards
• Model, design, and maintain data warehouse including table structures, stored procedures, views, and functions

LTIMindtree is an equal opportunity employer that is committed to diversity in the workplace. Our employment decisions are made without regard to race, color, creed, religion, sex (including pregnancy, childbirth or related medical conditions), gender identity or expression, national origin, ancestry, age, family-care status, veteran status, marital status, civil union status, domestic partnership status, military service, handicap or disability or history of handicap or disability, genetic information, atypical hereditary cellular or blood trait, union affiliation, affectional or sexual orientation or preference, or any other characteristic protected by applicable federal, state, or local law, except where such considerations are bona fide occupational qualifications permitted by law.

Associate Attorney – Special Education & Disability Rights

Freeman Law Offices, LLC

New Jersey / Pennsylvania (Hybrid)

Freeman Law Offices is a boutique law firm dedicated to representing students with disabilities and their families in complex special education matters. Our practice focuses on high-level legal advocacy under the Individuals with Disabilities Education Act (IDEA), Section 504 of the Rehabilitation Act, and related civil rights laws.

We represent families in administrative due process hearings, federal litigation, and strategic advocacy to ensure that students with disabilities receive appropriate educational services.

We are seeking an Associate Attorney who is passionate about civil rights and education equity and who wants meaningful courtroom and advocacy experience.

What You'll Do

The Associate Attorney will work closely with the firm's principal attorney on a wide range of matters, including:

• Representing families in special education due process hearings, federal court and class action litigation
• Conducting legal research and drafting briefs, motions, and memoranda
• Preparing cases for administrative hearings and federal court litigation
• Participating in IEP meetings and settlement negotiations
• Reviewing educational records, evaluations, and expert reports
• Developing legal strategies for complex IDEA and disability rights matters
• Working directly with families navigating the special education system

This role offers substantial responsibility and hands-on litigation experience.

Ideal Candidate

We are looking for a thoughtful and motivated attorney who:

• Is admitted (or eligible for admission) in New Jersey or Pennsylvania
• Has a minimum of 3 years of legal experience
• Has strong legal research and writing skills
• Is passionate about civil rights, disability rights, and/or education law
• Is comfortable managing complex factual records
• Works well both independently and collaboratively

Experience in education law, civil rights litigation, administrative law, or public interest law is a plus but not required.

What Makes This Role Unique

This position offers the opportunity to:

• Develop expertise in a highly specialized and impactful area of law
• Work closely with leading experts in psychology, education, and disability services
• Gain significant litigation experience early in your career
• Help families secure meaningful educational opportunities for their children

Compensation

Competitive salary based on experience, with opportunities for professional growth and increasing responsibility.

Location

Hybrid position serving clients throughout New Jersey and Pennsylvania.

How to Apply

Please submit to :

• Cover letter and Resume
• Writing sample

Wong Fleming is litigation law firm with nationwide offices throughout the United States, and headquartered in Princeton, New Jersey. The firm values diversity and strong advocacy while upholding high standards of professional conduct. Wong Fleming attorneys strive to vigorously pursue their clients' interests with civility to the bench and fellow members of the Bar.

Role Description

This is a full-time position for a Litigation Associate Attorney at Wong Fleming. This position will be responsible for commercial litigation matters. While the role is based in Princeton, NJ, some remote work is permitted. Candidate must be able to collaborate with clients other members of the firm, and have an appreciation for all aspects of the practice of law and the business interests of our clients.

Requirements

• Admitted to practice in New York and New Jersey preferred, Pennsylvania a plus
• 1 to 2 years litigation experience is required, 3 to 4 years litigation experience is preferred
• Experience in commercial and insurance law is a plus
• Strong research abilities
• Exceptional organizational & time-management skills to meet strict deadlines
• Excellent legal writing and communication skills
• Highest ethical standards and professional integrity
• Strong interpersonal skills and ability to work easily with senior management and employees at all levels throughout the organization
• Ability to work independently and collaboratively

Salary pay range

• $80,000 - $135,000 per year

Benefits

• Medical, Dental & Vision Benefits
• 401K Benefits
• Paid Time Off (PTO)
• Opportunities to work remotely

About Williams-Sonoma DC - South Brunswick, NJ

Since it was founded in 1956, Williams - Sonoma has grown from Chuck Williams' single store in Sonoma, CA into one of the largest retailers in the country, with some best known and most beloved brands in home furnishings, including Williams – Sonoma, Pottery Barn and West Elm.

Our Distribution Centers serve as vital connections between factories and our retail, online and mail-order customers around the world. The Supply Chain environment is dynamic and fast-paced, and the network is expanding rapidly. If you have a background in distribution, manufacturing, engineering, transportation, finance, human resources, or home delivery – and are looking for a job with a strong opportunity for gaining new skills and for advancement – our Supply Chain Organization could be just the place for you.

Williams-Sonoma, Inc Supply Chain Overview

By managing resources responsibly, caring for our people, and uniting around our values, we lead our industry and are proud to be recognized for our continuous action and progress in the following areas: Barron's 100 Most Sustainable Companies; Forbes Best Employers for Women and Diversity; Newsweek America's Most Responsible Companies; and USA Today Customer Service Champions. These honors reflect that we are truly a people-first organization.

• Over 4,000 Full-Time Associates across the Supply Chain
• 14.5M square feet of small parcel, personalization, furniture, and manufacturing space in the domestic US, Williams-Sonoma has developed an agile and capable distribution network consisting of the following:
• Large package / furniture distribution centers located in Southern California, Northern California, Texas, Georgia, and New Jersey totaling 9.2M square feet plus another 1.2M square feet of standalone final-mile furniture hubs.
• Small package eCommerce distribution centers located in Mississippi and Arizona totaling 3.2M square feet, consisting of over 1,000 full-time associates and 1,500 seasonal/temporary associates in Mississippi
• Sutter Street Manufacturing upholstery factories located in North Carolina and Mississippi totaling with over 1,400 full-time employees producing approximately $900 million to $1 billion in sales of upholstered furniture
• Transportation Department for Ocean, Air, Trucking, and Rail consisting of over 30 transportation professionals located in Memphis, TN
• 700 associates in our Sourcing offices in 10 countries in Asia and Europe including China, Vietnam, Singapore, India, Italy, and Turkey

The Operations Manager is located in South Brunswick, NJ.

You'll be excited about this opportunity because you will....

• Lead, coach, and develop company associates while fostering a culture of accountability, continuous improvement, and high performance
• Oversee labor scheduling, shift planning, and attendance tracking while monitoring employee productivity and operational efficiency
• Identify performance gaps and implement corrective actions through coaching, training, and structured performance management
• Conduct regular safety meetings, training sessions, and compliance audits to maintain workplace safety and operational excellence
• Drive operational discipline through performance reviews, metric tracking, and continuous improvement initiatives
• Oversee daily distribution center operations, ensuring efficient execution, cost control, and adherence to performance metrics. Monitor line-haul optimization strategies to improve delivery speed, delivery quality, and operational efficiency while reducing operating costs
• Build, maintain, and manage strong relationships with third-party delivery partners (3PLs), independent contractors, and company employees to ensure consistent adherence to company policies, operating standards, and service expectations
• Conduct routine performance reviews of third-party partners and support contract alignment to ensure delivery performance, service quality, and cost efficiency meet business objectives
• Drive a customer-centric culture by improving on-time shipping and receiving, reducing damages, and improving return and replacement rates
• Manage customer escalations and determine appropriate resolutions to maintain high service standards and overall customer satisfaction
• Develop and execute contingency plans to manage seasonal demand fluctuations, weather disruptions, and other logistical challenges that may impact delivery operations
• Oversee warehouse organization and dock operations to ensure safe and efficient staging, loading, and dispatch
• Maintain compliance with OSHA regulations and company safety policies through regular inspections, risk assessments, and incident investigations, implementing corrective actions as needed
• Ensure effective inventory control processes are in place to maintain accurate shipment tracking and minimize loss or damage

Check out some of the required qualifications we are looking for in amazing candidates....

• High School Diploma or Equivalent, and 3 - 5 years of furniture/final mile distribution or manufacturing management/leadership experience
• In lieu of a degree, 6-8 years of progressively responsible furniture/ final mile distribution leadership experience
• This is an onsite and in office role
• Strong ability to communicate effectively (written or verbal), with excellent interpersonal and customer relations skills
• Must be highly organized and process oriented
• Ability to complete multiple tasks consistently and on time
• Warehouse Management System experience
• Solid understanding of Safety and OSHA standards
• Exceptional organizational and time management skills to successfully respond to urgent situations
• Ability to adapt and change processes to keep pace with the evolving business requirements
• Strong technical skills included but not limited to Microsoft Access, Excel, Word, PowerPoint

We prefer some of these qualities as well....

• Six Sigma Black Belt or demonstrated Lean Manufacturing experience
• Knowledge and execution of Final-mile delivery models, including white-glove service and same-day or multi-day delivery routing
• Exposure to furniture manufacturing, distribution and/or big box distribution
• Final Mile Transportation carrier contract negotiations or procurement experience
• Expert understanding Safety and OSHA standards
• Bilingual in Spanish

Review these physical requirements, as they play a major part in this role....

• While performing the duties of this job, the associate is required to stand, walk, talk and hear
• Associates must be able to move, lift or carry heavy objects or materials up to 50-100 pounds

Our company benefits are second to none in the industry....

• Generous discount on all Williams-Sonoma, Inc. brand products
• 401(k) plan and other investment opportunities
• Paid vacations, Employee Assistance Programs, Time Off to Volunteer, Matching Gifts Community Service Program, and Holidays (in some locations)
• Health benefits, dental and vision insurance, including same-sex domestic partner benefits, Legal and Identity Protection Plans and Pet Insurance
• For more information on our benefits offers, please visit
• To learn more about our Supply Chain culture and regional associate events, please visit: (Login credentials may be required)

EOE

About Made Scientific

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

Position Summary

The Sterility Assurance Program Lead (Associate Director) is a quality and technical leader responsible for establishing, maintaining, and continuously improving a robust sterility assurance and contamination control program across GMP cell therapy operations, from clinical through commercial stages. Reporting to the VP of Quality and Compliance, this individual will work in close partnership with Technical Operations, QC, Site Quality Operations, Plant Operations, and MSAT to ensure consistent aseptic execution, clear functional accountability, and sustained compliance with global regulatory expectations for advanced therapies.

Key Responsibilities

Sterility Assurance & Contamination Control Program

• Design, implement, and sustain a comprehensive Sterility Assurance and Contamination Control Strategy (CCS) aligned with global GMP expectations for cell therapy manufacturing.

• Ensure sterility assurance principles are embedded across facility design, equipment, processes, personnel practices, and quality systems for both clinical and commercial operations.

• Maintain alignment with applicable regulations, including 21 CFR Parts 210/211, 1271, EU GMP Annex 1 & 2, ICH guidance, and evolving global expectations for ATMPs.

Aseptic Operations & Functional Ownership

• Define and govern clear functional ownership of sterility assurance activities across Technical Operations and Quality functions.

• Provide oversight to ensure appropriate independence, compliance, and cross-functional collaboration.

Environmental Monitoring & Data Oversight

• Oversee the design and maintenance of Environmental Monitoring (EM) programs, including EMPQ, EMRA, sampling plans, alert/action limits, and response strategies.

• Review EM trends and contamination indicators to maintain a sustained state of control.

• Lead cross-functional discussions on EM excursions, contamination events, and risk mitigation.

Aseptic Process Validation & Risk Management

• Provide sterility assurance leadership for aseptic process simulation and validation.

• Oversee media fill design, execution, and failure investigations.

• Lead contamination risk assessments for process changes, new equipment, facility modifications, or tech transfers.

• Drive root cause analysis and CAPA development related to sterility assurance events.

Quality Systems Interface & Continuous Improvement

• Author, review, and approve SOPs, policies, and standards related to sterility assurance and contamination control.

• Partner with Quality Systems to embed sterility assurance into deviation management, change control, CAPA, and training systems.

• Analyze sterility assurance trends to identify systemic risks and drive continuous improvement.

• Support sterility readiness for new site start-ups, expansions, tech transfers, and product launches.

Regulatory Inspections & Audit Support

• Act as Sterility Assurance SME during regulatory inspections, client audits, and internal audits.

• Lead inspection preparation, including gap assessments, mock audits, and SME coaching.

• Lead or support response drafting for sterility-related findings, including 483s, regulatory commitments, and client observations.

Leadership, Influence & Collaboration

• Provide mentorship and leadership to sterility assurance SMEs across sites.

• Influence and align stakeholders across Quality, Technical Operations, QC, MSAT, Facilities, and Program Management.

• Advise senior leadership on sterility assurance risks, contamination trends, and program maturity.

• Champion a proactive, science-based, and inspection-ready sterility assurance culture.

Required Qualifications

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

• 10+ years of progressive experience in GMP-regulated cell therapy, gene therapy, biologics, or advanced therapy manufacturing.

• Deep expertise in aseptic processing and sterility assurance for non-terminally sterilized products.

• Strong working knowledge of global GMP regulations (FDA, EMA, ICH, Annex 1).

• Demonstrated experience supporting clinical and commercial GMP operations.

• Proven ability to lead cross-functional programs and influence without direct authority.

• Strong communication skills for diverse audiences, from operators to regulators.

• Experience leading or supporting inspections, client audits, and internal audits.

• Flexibility to work variable hours to support operations and inspections.

• Strong organizational skills and ability to manage competing priorities.

Preferred Qualifications

• Experience working in a CDMO with multiple clients and programs.

• Direct experience with EU Annex 1 implementation and contamination control strategy.

• Experience supporting late-stage to commercial transitions or high-growth environments.

• Certification or training in microbiology, aseptic processing, Lean, or Six Sigma.

Education Requirement

• B.S. in a related field required.

Physical Requirements

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

• Willingness to work in CNC/ISO7-8 cleanroom environments.

• Ability to lift up to 25 lbs.

• Must be able to stand, bend, and perform physical tasks in manufacturing environments.

• Comfortable working with cell-based products and chemicals.