Eversheds Sutherland Training Contract Application Process Jobs in Usa

Founded by fans, Crunchyroll delivers the art and culture of anime to a passionate community. We super-serve over 100 million anime and manga fans across 200+ countries and territories, and help them connect with the stories and characters they crave. Whether that experience is online or in-person, streaming video, theatrical, games, merchandise, events and more, it's powered by the anime content we all love.

Join our team, and help us shape the future of anime!

As a (Contract) GTM, Partnership Marketing & Planning Senior Manager, you will support the execution and daily operations of the GTM & Planning team, including its leadership and its Partnership Marketing division. You will be an individual contributor working with the global team to build and achieve important programs, manage operational complexity, and lead planning excellence. This is a 6-month contract.

Be an operational and strategic backbone of the GTM & Planning team, ensuring projects and workflows move forward with consistency and excellence to guide Crunchyroll's global growth through its direct-to-consumer footprint presence and high-profile third-party partners such as Amazon, Apple, Roku, Comcast, Google and YouTube, PlayStation, Samsung, and many others.

Identify gaps, improve workflows, and suggest improvements without waiting for direction.

Oversee the development of executive-ready deliverables (dashboards, trackers, presentations, project plans), ensuring clarity, structure, and visual polish in every output.

Be the bridge between global HQ and international teams, ensuring on time information sharing, meeting facilitation, and on actions.

Summarize complex updates into clear insights and next steps, presenting leadership or regional leads with resulting questions or action items so that both teams can accelerate their path forward.

In partnership with team leadership, introduce global workflows in regions to integrate regional teams into the global organization further, facilitating process implementation and roadshows to present them.

Manage vendor operations, including POs, invoicing, briefings, contracts, timelines, and similar activities.

In the role of GTM, Partnership Marketing & Planning Senior Manager, you will report to the VP, GTM & Partnership Marketing.

We are considering applicants for the location of Los Angeles, CA.

We get excited about candidates, like you, because...

8+ years of experience in strategy, consulting, business operations, or project management in entertainment, media, tech, or gaming.

Experience working and managing multiple clients in leading consulting firms, or you are an alumnus of an MBA program.

Experience creating structured and visually refined presentation decks and spreadsheets (can maintain complex spreadsheets) for senior executives.

Have market and business awareness to connect daily actions with broader organizational goals and priorities, and identify opportunities for value creation.

Experience improving and streamlining operational processes, managing timelines, trackers, and follow-ups.

Experience in project managing multiple projects at a given time from concept to completion.

Experience note-taker turning discussions into next steps.

Experience working in a global organization and a distributed team environment with peers and partners in multiple time zones and locations across the world, with multiple cultures and backgrounds.

Both domestic and ever-expanding international efforts fuel Crunchyroll's global expansion. The GTM & Planning team works with US-based leadership and regional teams to develop go-to-market and partnership marketing plans and programs to expand Crunchyroll's growth through its direct-to-consumer presence and high-profile third-party distribution partners, delighting and super-serving anime fans, boosting its footprint and brand awareness while making Crunchyroll synonymous with anime worldwide.

#LifeAtCrunchyroll #LI-remote

We want to be everything for someone rather than something for everyone and we do this by living and modeling our values in all that we do. We value:

Courage. We believe that when we overcome fear, we enable our best selves.

Curiosity. We are curious, which is the gateway to empathy, inclusion, and understanding.

Kaizen. We have a growth mindset committed to constant forward progress.

Service. We serve our community with humility, enabling joy and belonging for others.

Our mission of helping people belong reflects our commitment to diversity & inclusion. It's just the way we do business.

We are an equal opportunity employer and value diversity at Crunchyroll. Pursuant to applicable law, we do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Crunchyroll, LLC is an independently operated joint venture between US-based Sony Pictures Entertainment, and Japan's Aniplex, a subsidiary of Sony Music Entertainment (Japan) Inc., both subsidiaries of Tokyo-based Sony Group Corporation.

At Northrop Grumman, our employees have incredible opportunities to work on revolutionary systems that impact people's lives around the world today, and for generations to come. Our pioneering and inventive spirit has enabled us to be at the forefront of many technological advancements in our nation's history - from the first flight across the Atlantic Ocean, to stealth bombers, to landing on the moon. We look for people who have bold new ideas, courage and a pioneering spirit to join forces to invent the future, and have fun along the way. Our culture thrives on intellectual curiosity, cognitive diversity and bringing your whole self to work - and we have an insatiable drive to do what others think is impossible. Our employees are not only part of history, they're making history.

Northrop Grumman Defense Systems Sector is seeking a Contracts Setup Group Manager (Contract Manager 3) to join our Sector Contracts & Pricing team. This position will be responsible for the setup and implementation of our contracts data/information in our ERP system, supporting the overall Sector, with direct support provided to multiple divisions. This role will report to the Defense Systems Sector Director of Contracts & Pricing and will reside at our Linthicum, MD or McLean, VA site, or other NG site.

• Work with Sector Contracts leadership in the establishment of a Sector Contracts Setup group.
• Lead the Sector Contracts Setup Group in support of loading, inputting and modifying a broad range of contracts into the SAP S/4 system.
• Identify/hire/manage contracts setup team
• Establish contract setup procedures and processes
• Develop and provide training for the contract set up group and setup stakeholders
• Collaborate with various functional stakeholders of the process to ensure a seamless transition
• Produce key reports and metrics
• Contribute to the strategic direction of the organization
• Perform as an integrated part of the ERP systems conversions, managing the transition of ERP systems to one centralized system related to Contract system functions - this will involve the transition of a division from CostPoint to SAP S/4 in January 2027.
• Provide input and support to our contract lifecycle management initiatives.

The successful candidate will work closely on a day-to-day basis with contract setup representatives, contracts, business management, and project accounting personnel. This role requires strong leadership skills, effective communication, and the ability to drive results.

• Bachelor's Degree and 10 years' of experience working in Contracts, Business Management, or related discipline or Masters Degree with 8 years of experience working in Contracts, Business Management, or related discipline
• Minimum of 4 years' experience managing a team
• Experience in leading geographically dispersed teams with diverse skillsets
• Proficiency in SAP (SD module), Contract Setup/Management related to SAP S4
• Experience defining requirements for systems to (1) perform key business processes and (2) extract, analyze, and visualize data to inform business decisions and results.
• Excellent written and verbal communication skills
• MS Office proficiency, specifically with Excel and MS PowerPoint

• Prior experience in working in S/4
• Prior experience in setting up contracts in S/4 or for entry into S/4
• Prior organizational development, team start up leadership experience
• Prior experience in setting up, or managing, a contracts setup group or team

Primary Level Salary Range: $147,500.00 - $231,800.00 The above salary range represents a general guideline; however, Northrop Grumman considers a number of factors when determining base salary offers such as the scope and responsibilities of the position and the candidate's experience, education, skills and current market conditions. Depending on the position, employees may be eligible for overtime, shift differential, and a discretionary bonus in addition to base pay. Annual bonuses are designed to reward individual contributions as well as allow employees to share in company results. Employees in Vice President or Director positions may be eligible for Long Term Incentives. In addition, Northrop Grumman provides a variety of benefits including health insurance coverage, life and disability insurance, savings plan, Company paid holidays and paid time off (PTO) for vacation and/or personal business.

Green | Evans-Schroeder (GES) is recruiting for multiple contract immigration attorneys with substantial experience in district court litigation, as well as appellate litigation at the Board of Immigration Appeals and the U.S. Circuit Courts of Appeal.

Our law firm has developed a national reputation for leaning into challenging and complex immigration cases, moving the needle forward in immigration law with progressive and high-impact litigation and advocacy. Working at (GES) is a rewarding experience for those who share our mission, which is to protect and advance the rights of the immigrant community. Our core values emphasize working collaboratively in a team-oriented environment; always demonstrating respect and dignity to our clients, and to ourselves; and embracing courage and creativity to overcome obstacles.

With an eye to the future, we have recently expanded our footprint from Tucson to Phoenix, and we are excited for the opportunity to serve and help more clients and their families in Arizona and around the world. As we continue on our journey, we remain committed to responsibly developing an organizationally healthy, diverse, and cohesive team of passionate immigration advocates.

Summary

Our law firm is seeking to hire, as independent contractors, multiple immigration attorneys with substantial experience and expertise with federal court litigation and immigration appeals. As an attorney working in this position, you will be responsible for projects that may include drafting complaints and petitions to initiate civil litigation in U.S. district courts, motions for preliminary injunctive relief, responses and replies to the government's pleadings, and drafting appellate briefs and motions for cases on appeal to the Board of Immigration Appeals and the U.S. Circuit Courts of Appeal.

What You'll Do

• Legal research and writing to develop legal arguments and litigation strategies
• Work closely with the law firm's full-time attorneys to support them and their clients with district court or appellate written work product
• Draft complaints and petitions to initiate civil litigation in U.S. district courts
• Write motions for preliminary injunctive relief, and prepare responses and replies to the government's pleadings
• Prepare opening and reply briefs for BIA and Circuit Court appeals
• Legal research and writing for other BIA and immigration court matters

Compensation and Benefits

• Attorneys filling this position are independent contractors and are ineligible for benefits
• Contract attorneys will accept or reject legal assignments on a per-project basis

What You'll Bring

• Juris Doctor degree and active licensure in good standing in at least one state, and membership in at least one federal district court
• No less than five years of substantial immigration federal court litigation experience

*All applicants must submit a resume, a cover letter, and two (2) writing samples.

We are actively hiring for a (Remote) Contract Litigation Attorney BAR LICENSED in Tennessee and living in either GA or TN. This need is long-term for an AmLaw 200 firm, working on litigation needs for a government client of the firm.

• You MUST HAVE CIVIL LITIGATION EXPERIENCE 3+ YEARS: with strong legal research skills (Westlaw, etc.) and solid brief-writing experience
• You MUST BE BAR LICENSED IN TN and live in either TN or GA to be considered for this position.
• Position is FULLY REMOTE, working Full-Time (30+ hours/week)
• Medical/Dental/Vision Benefits Available
• This is a long-term CONTRACT LITIGATION position.
• For consideration please submit your resume and cover letter to

Job Summary

In this role, you will support the legal department by drafting cover letters, subcontract addendums, and notices, as well as assisting General Counsel in carrying out all other duties and responsibilities as directed by General Counsel. You will also issue all Subcontracts, Purchase Orders, and PSAs for every project, in coordination with the Pre-Construction team.

Position Responsibilities

• Subcontract Issuance and Administration (includes all Subcontracts, Purchase Orders, and PSAs for every Project, and ensure timely completion.
• Careful and efficient coordination of Buy out process with Pre-construction team to ensure timely issuance and execution of all subcontracts for each project
• Draft cover letters,subcontract addendums, and notices
• Prepare summaries for General Counsel’s review regarding Owner contract terms which need to be incorporated into the subcontract templates
• Ensure all deadlines and conditions described in contracts are met
• Assist General Counsel in the drafting of contract summaries and checklists
• Ensure contracts are reviewed and executed in a timely manner
• Help organize physical and electronic legal department documents
• Offer general administrative support for the legal department
• File Sunbiz renewals for all Straticon related entities
• Assist General Counsel with scheduling agenda items

Required Skills

• Strong organization skills
• Ability to identify and summarize problems and issues, and analyze them for resolution
• Excellent written/oral communication skills
• Detail-oriented
• Willing to bring forth problems and concerns
• Bachelor’s degree or higher
• Skilled at using software and technology
• Resourcefulness
• Multitasking
• Time management

Preferred Skills and experience

• Paralegal certificate preferred
• Adobe Acrobat
• DocuSign
• Navigating public records websites
• Prior work experience in a law firm or similar environment

Our client, a top financial company with offices in NYC, is seeking a temporary Senior Managing Counsel/Finance Contract Attorney for its team on a hybrid basis. (4x per week)

This role will support our client's Fixed Income and Equities (FIEQ) institutional sales and trading businesses. A successful candidate will work closely with senior business managers involved in an array of broker-dealer and bank services including institutional trading of equity and fixed income securities, ETFs, equity and debt capital markets, municipal securities offerings, and outsourced trading.

Experience in the prime brokerage space would be very helpful.

This role is located in Pittsburgh PA, Lake Mary FL or New York NY.

In this role, you’ll make an impact in the following ways:

• Providing advice and assistance to business, Credit, Risk and Compliance partners concerning legal, regulatory and reputational issues arising from FIEQ businesses.
• Advising on new markets, new product and service development, and strategic business initiatives.
• Working closely with business managers and company control functions (Compliance, Credit, Risk, Legal) to ensure understanding of the bank's regulatory and contractual obligations;
• Drafting, reviewing and negotiating legal contracts and other documents;
• Monitoring, interpreting and communicating on proposed regulations and their application to the business;
• Overseeing and managing the retention of outside counsel on business initiatives and other matters; and
• Maintaining an understanding of global regulatory issues impacting the business through engagement with APAC and EMEA colleagues.

To be successful in this role, we’re seeking the following:

• Law degree (J.D.) and licensed to practice law in New York Pennsylvania or Florida
• Minimum 12 years of experience at a law firm and/or large financial institution covering fixed income and equity sales and trading activities
• Experience with industry standard trading agreements
• Knowledge of current regulatory issues impacting institutional sales and trading and capital markets businesses.
• Excellent verbal and written communication skills and the ability to interact professionally with a diverse group of executives, managers, and subject matter experts

An ideal candidate has trading desk support, ETF experience, Muni experience, market trade experience, familiarity with the 33/34 act, and familiarity with FINRA.

Comp - $100/hour+ depending on experience

Job Title: Director Process Development and Manufacturing, CMC

Department: CMC

Reports to: Chief Technical Officer

About the Company:  

Opus Genetics is committed to building an innovative, efficient and sustainable science based and commercial ophthalmic biopharmaceutical company leading the development of transformative gene therapies for the treatment of inherited retinal diseases (IRDs) and therapies to treat patients with other retinal and refractive disorders.

Job Summary: 

The Director of Process Development and Manufacturing will be the technical lead for development and manufacturing of assigned assets within the Opus gene therapy programs focusing on technical transfer and process development and execution supporting product development and manufacturing to achieve company goals and strategies. This includes working collaboratively with external partners (i.e. CDMOs, contract labs, suppliers) to develop technical studies, analyze complex data, make data driven decisions, and author, review, and approve technical and regulatory documents. The ideal candidate will have a deep technical understanding of AAV gene therapy upstream and downstream development and process optimization.  This role will directly interact with the CDMO/contract partners and be responsible for building and maintaining excellent working relationships. Knowledge of manufacturing platforms, consistent with AAV technology, at scales ranging from process development through GMP and PPQ activities. The candidate will be hands-on and expected to provide content to all these areas. 

Duties/Responsibilities: 

·      Work with Opus CDMO/contract manufacturing and laboratory partners to develop a phase appropriate robust manufacturing program to support the process development and engineering of pre commercial and commercial cGMP material to support pre-clinical studies, clinical trials, and commercial supply. 

·      Support, author, and review/approve manufacturing plans and documentation including technical transfer, batch records and documentation, product specifications, stability programs, bridging and comparability studies, and other reports utilizing phase appropriate QbD best practices.

·      Support, author, and review/approve manufacturing documentation including testing records, certificates of testing/analysis, campaign summary reports, investigations, etc. 

·      Support, author, and review/approve regulatory documentation including pINDs, INDs, agency responses, CMC meeting requests and briefing packages, and BLAs.   

·      Ensure proper reference standard material is in place, tested, and released for each product. Lead technology transfer between sites. 

·      Ensure regulatory requirements are in place to support manufacturing campaigns with respect to Master Cell Banks, Plasmids, Drug Substances, Drug Products, and Diluents, to prevent developmental delays and or interruptions to clinical programs or regulatory filings.

·      Perform the role of person in plant as needed at the Opus CDMO/contract manufacturing partner’s sites. Act as the CMC expert during audits and interactions with regulatory agencies. 

·      Manage work to project plans for multiple gene therapy programs in the preclinical, pre-IND, IND/clinical, and commercial stages. 

·      Identify and lead the resolution of operational and functional level challenges, work with program and/or function managers to escalate issues to senior management.

·       Hands on resolution to issues/content generation. Design effective and high-quality presentations and progress reports, as requested.

Supervisory Responsibilities: 

·      None 

Education and Experience: 

·      Master’s degree (minimum) from an accredited institution in a science or health-related field with minimum of 7-10 years of experience in the pharmaceutical or biotechnology industry. Ophthalmology experience is preferred.

·      Additionally, a minimum of 5 years of direct manufacturing experience for biopharmaceuticals. Preference will be given for direct AAV gene therapy experience. Previous CDMO/contract lab experience also preferred.

·      Experience designing and executing technical transfer and scale up campaigns and associated documentation.

·      Experience in writing and reviewing regulatory submissions including pINDs, INDs, Meeting Requests/Briefing Packages, Annual Report/DSUR’s, and BLAs. 

·      Experience with FDA and/or other regulatory agency requirements and interactions.

·      Strong skill set in interacting with multidisciplinary teams for preclinical and clinical development. Clear understanding of the drug development process with experience in multiple phases.

·      Experience with Orphan/Rare Disease programs, and/or Fast Track/Breakthrough Therapy is a plus.

·      Demonstrated leadership skills and ability to influence across all levels of a cross-functional team without direct managerial authority. Experience in risk assessment, negotiation, and problem solving/mitigation.

·      Outstanding interpersonal skills, ability to communicate effectively in both oral and written form, with effective time management skills needed to manage multiple ongoing projects simultaneously.

·      Demonstrated advanced computer software proficiency (Word, Excel, Smartsheet’s, PowerPoint, etc.).  

Physical Requirements:  

·      Ability to travel 20% of time

·      Ability to work in laboratory settings/situations

·      Prolonged periods sitting at a desk and working on a computer. 

·      Must be able to lift up to 15 pounds at times. 

Location:

This position is currently based in the Durham North Carolina area; Hybrid/ remote options considered.

 Salary Range:

$190,000-210,000

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. 

Opus Genetics is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. 

Senior Director, Process Engineering & Contract Manufacturing Scale-Up

Location: Durham, NC (In-Office) 

Reports To: SVP Operations

Applying

To apply directly to this role, please email a non-ChatGPT paragraph explaining why you believe you would be the best fit for this role and attach your resume as a PDF. Applying via email is the only way to be considered.

About Carpe

Carpe is the fastest-growing deodorant brand in the United States. Our team is composed of ~25 incredibly smart people working together in person in downtown Durham, NC. Our office is open, collaborative, and high energy.

We build products that solve real problems for millions of people who struggle with excessive sweating. Our growth over the past several years has been rapid, and we are continuing to expand across retail, ecommerce, and new product categories.

As the company scales, building a strong, reliable, and scalable manufacturing foundation is critical to our long-term success.

The Role

We are seeking a high-ownership process engineering leader with a strong chemical engineering background who thrives in fast-growing environments and enjoys building systems that support scale. This is not a procurement or vendor management role. It is a technical manufacturing role focused on process engineering, scale-up, and improving manufacturing performance.

This role exists to build Carpe’s manufacturing process engineering capability as we expand production across multiple product categories and manufacturing partners. The primary focus is on developing robust, scalable processes that consistently deliver product performance.

This is a hands-on technical role. You will work directly with manufacturing teams to define critical process parameters, troubleshoot production challenges, and improve process reliability as we scale.

You will partner closely with Product Development, Operations, and Quality to translate product innovation into well-defined, scalable manufacturing processes. Success in this role requires the ability to develop long-term process engineering frameworks while also working directly with manufacturing teams to solve technical challenges and improve production performance.

What You’ll Do

Process Engineering & Manufacturing Science

• Build and lead Carpe’s internal manufacturing process engineering capability
• Work directly with contract manufacturing teams to document and refine production processes
• Identify and define critical process parameters that drive product consistency and performance
• Lead process characterization work, including DOE design and execution
• Improve process robustness and repeatability across manufacturing partners
• Troubleshoot complex manufacturing challenges and support manufacturing teams in solving production issues
• Drive continuous improvement initiatives across manufacturing operations

Technology Transfer & Product Scale-Up

• Lead the technical transfer of new products from development into commercial manufacturing
• Work directly with contract manufacturers to scale formulations and processes successfully
• Partner closely with Product Development to translate product specifications into scalable manufacturing processes
• Oversee pilot trials, validation runs, and commercialization readiness for new product launches
• Ensure new products are successfully and reliably launched across manufacturing partners

Manufacturing Performance & Continuous Improvement

• Establish operational metrics and performance tracking across contract manufacturing partners
• Improve manufacturing efficiency, yield, and process reliability
• Lead root cause investigations and corrective actions related to manufacturing issues
• Implement stronger process control and operational discipline across manufacturing partners
• Develop scalable manufacturing frameworks that support continued company growth

Cross-Functional Collaboration

• Partner closely with Product Development to ensure manufacturing processes support product performance requirements
• Collaborate with Quality and Regulatory to ensure manufacturing processes meet compliance and quality standards
• Work with supply chain and planning teams to support production scheduling and inventory needs
• Provide manufacturing insight during product development and innovation planning

Contract Manufacturing Leadership

• Own and manage Carpe’s network of contract manufacturing partners
• Build strong working relationships with technical teams at manufacturing partners
• Improve operational performance across quality, delivery, and cost
• Lead onboarding and qualification of new manufacturing partners as capacity expands
• Ensure manufacturing partners are prepared to support both current production and future growth
• Serve as the primary operational leader responsible for manufacturing performance across the network

Who You Are

• Bachelor’s degree in Chemical Engineering, Manufacturing Engineering, or a related technical discipline
• 10–15+ years of experience in manufacturing, process engineering, or operations leadership within consumer packaged goods, personal care, or related industries
• Experience with emulsions, OTC personal care, or topical formulation manufacturing
• Experience managing contract manufacturing networks and external production partners
• Strong technical background in manufacturing processes and scale-up
• Experience working with highly structured emulsions or shear-sensitive formulations
• Demonstrated ability to build systems, processes, and infrastructure in growing organizations
• Comfortable operating in fast-moving environments where both strategy and hands-on execution are required
• Willing and able to travel a lot (and last minute) 
• Strong engineering instincts and problem-solving ability
• Ability to work directly with manufacturing partners to improve processes and solve technical challenges

Bonus If You Have

• Background in manufacturing engineering or process engineering leadership roles
• Experience scaling products across multiple contract manufacturing sites
• Experience building manufacturing infrastructure in high-growth CPG environments

What You’ll Get

• Direct collaboration with senior leadership as we scale the business
• Opportunity to build and own Carpe’s manufacturing infrastructure during a major growth phase
• Competitive compensation based on experience and level
• Health, vision, and dental coverage
• Flexible PTO
• A front-row seat to the growth of one of the most disruptive brands in body care



Applying

To apply directly to this role, please email a non-ChatGPT paragraph explaining why you believe you would be the best fit for this role and attach your resume as a PDF. Applying via email is the only way to be considered.

Kelly® Science & Clinical is seeking a Quality Assurance Validation Specialist for a contract position at a premier pharmaceutical client in Irvine, CA If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Empowering Experts.

Job Title: QA Validation Specialist (Contract)

Duration: 10 months

Location: Irvine, CA (onsite)

Rate: $38–40/hr.

This position involves hands-on ownership of equipment, facility, and laboratory validations. Ideal for experienced validation professionals who excel in regulated environments and enjoy driving projects from protocol development through audit-ready execution.

RESPONSIBILITIES:

• Assists in assuring facility, manufacturing, packaging, and Laboratory equipment are qualified to the required cGMP standards.
• Authors/approves and executes qualification protocols and reports.
• Schedules, plans, manages performance qualifications, calibration and maintenance of equipment and utility systems and laboratory Instruments in coordination with operations, Quality Control and maintenance.
• Assists sourcing and procurement of facility equipment and Laboratory Instruments through completion of following tasks
• Qualification of Vendors Selected.
• Input to the development of the URS/FRS/DDS.
• Assists with the routine calibration and maintenance of the Validation Master Plan for the site.
• May present qualification studies to Regulatory and Client Auditors as required.
• Assists with the design, maintenance, and continual improvement of the qualification system in line with cGMP standards.
• Provides technical expertise and guidance on qualification policies and procedures and the implementation of those within the Production and Quality functional areas.
• Occasionally supervises specialized contract personnel and outside vendors in the performance of contract services.
• Summarizes studies and authors qualification reports in compliance with the cGMP standards and in a timely manner.
• Develops and executes matrix type validations where applicable for processes and equipment with adequate supporting rationales.
• Initiates and investigates exception reports and non-conformances, associated with the qualification studies. Troubleshoots and resolves technical issues.
• Other responsibilities and special projects will be assigned based on business and customer needs.

QUALIFICATIONS:

• Bachelor’s degree in Sciences
• 5+ year’s of experience in a highly regulated pharmaceuticals industry or related field
• Strong working knowledge of cGMP and regulatory standards for validation.
• Experience in writing and reviewing SOPs, GMPs, governmental regulations and/or protocols for accuracy, traceability and compliance.
• Demonstrated experience with qualification of commercial processing a packaging equipment.
• Proven track record of managing projects from start to finish on time and on budget.

What happens next:

Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

We are seeking an experienced Contract Project Manager to lead the design, construction, validation, and operational readiness of a new 503B Outsourcing Facility in Charleston, SC. This project involves the build-out of a modular cleanroom pharmaceutical manufacturing area, within an existing structure, to be compliant with U.S. FDA 503B regulations and current Good Manufacturing Practices (cGMP) as outlined in 21 CFR Parts 210 and 211.

The Project Manager will oversee the full lifecycle of the facility build, including planning, vendor coordination, cleanroom installation, utilities integration, validation, regulatory readiness, and handoff to operations.

Key Responsibilities

Project Leadership & Execution

• Lead end-to-end execution of a modular cleanroom manufacturing and supporting structure area build.
• Develop and manage detailed project plans, budgets, schedules, and milestones.
• Coordinate cross-functional stakeholders including Engineering, Quality, Regulatory, Validation, Manufacturing, and Executive Leadership.
• Serve as the primary point of contact for contractors, cleanroom vendors, equipment suppliers, and consultants.
• Proactively identify risks and implement mitigation strategies to maintain timeline and budget.

Facility Design & Construction Oversight

• Oversee modular cleanroom design, fabrication, delivery, and installation.
• Ensure facility layout supports compliant workflows, material/personnel flows, and environmental controls.
• Coordinate mechanical, electrical, plumbing (MEP), HVAC, HEPA filtration, and critical utility systems (WFI, clean steam, compressed gases, etc.).
• Manage general contractors and subcontractors to ensure compliance with project specifications and cGMP requirements.

Regulatory & Compliance Alignment

• Ensure facility design and build align with Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable FDA guidance.
• Support readiness for FDA inspection and state Board of Pharmacy requirements.
• Collaborate with Quality and Validation teams to ensure proper documentation (URS, FS, DS, IQ/OQ/PQ protocols).
• Ensure adherence to cGMP standards and applicable USP chapters (e.g., USP , ).

Validation & Commissioning

• Oversee commissioning and qualification activities for cleanrooms and critical systems.
• Coordinate environmental monitoring setup and validation activities.
• Support process simulation activities for sterility assurance.
• Support development of SOPs related to facilities and equipment.
• Ensure successful facility turnover to Manufacturing and Quality teams.

Budget & Reporting

• Manage capital expenditure budget and vendor contracts.
• Track project performance metrics and provide regular executive-level updates.
• Ensure change control processes are followed for scope, schedule, and budget modifications.

Required Qualifications

• 7+ years of project management experience in pharmaceutical, biotech, or sterile compounding environments.
• Demonstrated experience leading construction or expansion of GMP-regulated manufacturing facilities.
• Direct experience with cleanroom builds (ISO 7/8 and higher classification preferred).
• Strong knowledge of FDA cGMP regulations and 503B outsourcing facility requirements.
• Experience managing modular construction projects preferred.
• Advanced proficiency with MS Project and/or other project management software.
• Proven ability to manage multi-vendor, cross-functional projects with aggressive timelines.
• Bachelor’s degree in Engineering, Construction Management, Life Sciences, or related field (PMP certification preferred).

Preferred Experience

• Prior experience building or remediating a 503B outsourcing facility.
• Experience preparing facilities for FDA inspection.
• Familiarity with Charleston, SC permitting and construction environment.
• Background in sterile injectable manufacturing.

Key Competencies

• Strong leadership and stakeholder management skills
• Excellent organizational and documentation practices
• Risk-based decision-making approach
• Detail-oriented with strong compliance mindset
• Ability to work on-site in Charleston, SC for critical phases

Deliverables

• Completed modular cleanroom facility delivered on time and within budget
• Fully commissioned and qualified GMP-compliant facility
• Inspection-ready documentation package
• Successful transition to operational manufacturing

This contract role offers a unique opportunity to lead the build of a state-of-the-art 503B modular pharmaceutical manufacturing facility from the ground up within an existing building. The ideal candidate thrives in complex, regulated environments and brings both construction execution expertise and deep GMP knowledge.

To apply, please submit your resume and a brief cover letter describing your relevant