Agile Iterative Development Process Jobs in Usa

I’m recruiting for a client that provides environmental services throughout the development process. With a holistic approach that integrates expertise in planning, entitlements, and environmental consulting, their team helps clients maintain greater control over project outcomes, timelines, and overall development costs.

They are seeking a Project Manager with experience in due diligence, entitlements, and post-entitlement processes. In this role, you will collaborate with architects, designers, and civil engineers to guide projects through local government approvals and move developments forward.

Responsibilities:

• Ability to estimate and develop appropriate project scopes and budgets with minimal oversight
• Ensure all assigned project tasks are completed on-schedule and within budget
• Consistently engages in project solutioning with required internal and external stakeholders
• Proactively mitigates projects risks and issues and can successfully navigate complex project requests
• Initiates and leads decision making meetings with jurisdictions and project stakeholders.
• Manages and coordinates community outreach for controversial projects and can navigate political opposition.
• Understands the nuanced requirements of multiple project types and design criteria
• Has strong technical knowledge and understands CEQA and technical study impacts to project and project schedule
• Anticipate and prepare/delegate change orders and contract amendments and manage escalations as needed
• Ensure all internal and external interactions with team members, vendors, and clients meet expectations
• Provide consistent leadership and mentorship to project management team and junior associates

Qualifications:

• Bachelor’s degree and 5-7 years of related work experience or equivalent combination required
• Strong leadership ability and experience required
• Knowledge of entitlement and post-entitlement processes required
• Proven interpersonal skills with emphasis on communication and emotional intelligence
• Ability to manage several projects simultaneously with advanced problem-solving skills
• Understands multiple project types and requirements including CEQA and technical studies
• Intermediate to advanced Microsoft Word and PowerPoint experience required
• Experience with development related software (e.g., Smart Sheet, Microsoft Project, and/or Bluebeam) required
• Experience in reading technical reports, construction and design drawings, and municipal codes required

Sr. Product Development Manager

Position Overview
Our client in the automotive accessories industry is looking for a Senior Product Development Manager. This is a full-time, onsite role. The position begins as soon as early-mid April and is a long-term, permanent hire.

This role is HYBRID, onsite, in Richmond, IL M-Th. WFH Friday.

Key Responsibilities

• Own the full front-end product development process from ideation through validation, development, and handoff for commercialization
• Lead concept creation, competitive analysis, and early-stage innovation for key automotive accessory categories (seat covers, steering wheel covers, cushions, floor mats, mobile accessories)
• Develop complete product briefs, determine feasibility, and guide designers through early stages of product creation
• Build and present business cases including pricing, margin targets, positioning, and financial analysis
• Partner with global suppliers and factories to develop prototypes, optimize cost structures, and ensure manufacturability
• Approve prototypes and oversee all aspects of testing, quality, compliance, and packaging
• Ensure projects meet timeline, cost, and quality targets throughout a 4-Stage Gate process (Ideate -- Validate -- Develop -- Commercialize)
• Collaborate closely with marketing on launch tiers and go-to-market strategy (Gold/Silver/etc.)
• Lead portfolio strategy by managing both new product development and existing product improvements
• Identify cost savings, margin enhancements, and line optimization opportunities post-launch
• Provide leadership and potential direction to a small team based in Richmond and Australia (future direct reports)
• Support the organizations shift from an in-store product mindset to a digital-first product strategy
• Report directly to the VP of Product

Qualifications

• Proven ability to develop, launch, scale, innovative products. 
• 10+ years in product development, product management, or category management.
• Experience working within a stage gate or NPD product development process.
• Prior leadership experience leading teams.

In this position, you may have access to client or customer systems, confidential and/or proprietary information or data. This position is onsite and requires you to work closely with other individuals in a collaborative team environment.

Lightwave Logic: (Nasdaq: LWLG) is a publicly traded materials and device development company that is conducting cutting-edge work to commercialize its proprietary organic nonlinear polymers for a variety of electro-optic devices and pushing the state of the art in high-speed fiber-optic telecom and data communications. Our development roadmap is geared to disrupt the industry by introducing organic modulators and related photonic integrated circuits that have superior speed, lower power consumption, and smaller size than current technologies. Our materials and devices are extendable into other applications, including sensors and instrumentation.

Job Description

We are seeking a Process Chemist to join our team in Englewood, CO. The Process Chemist designs, develops, optimizes, and scales chemical processes for the pilot to large-scale manufacturing of intermediate and finished products. The Process Chemist leverages their expertise in ensuring that chemical processes are developed so that the chemical reaction(s) is carried out efficiently, safely, and economically, and are within quality and regulatory compliance. By staying current with scientific literature and collaborating across teams, they drive innovation and efficiency. This role involves supporting IP development, maintaining safety standards, and contributing significantly to the team's success in achieving company goals.

Responsibilities

• Designing, developing, and optimizing chemical processes to improve efficiency, yield, and product quality.
• Conducts laboratory experiments to understand chemical reactions and improve process conditions.
• Ensure that chemical processes comply with regulatory requirements and safety standards.
• Conduct small, pilot, or large-scale manufacturing of intermediates and/or finished products.
• Write/execute technical reports, standard operating procedures, and batch records.
• Ability to work second shift, when needed.
• Remain current on relevant scientific literature.
• Work collaboratively with colleagues across the company; use this collaboration to support the company's goals and improve the chemistry team's output.
• Punctually and thoroughly record all work and data in e-notebook, as well as summarize and report ongoing work to the group regularly.
• Exhibit safety awareness, safe work practices, and common laboratory hygiene, and ensure that all members of the chemistry team abide by the safety policies of the company.
• Other duties and projects as assigned.

Qualifications

• BS/MS in chemistry, chemical engineering, or a related discipline.
• 1-3 years’ experience with process development, process optimization, and/or scale-up.
• An understanding and/or familiarity with regulatory compliance in chemical manufacturing.
• Knowledgeable in chemical reaction mechanisms, kinetics, and environmental health and safety practices.
• Ability to use analytical instrumentation (HPLC, GC-MS, DSC, pH meter, etc).
• Ability to operate pilot to large-scale chemistry equipment (chemical reactors, pumps, distillation equipment, etc).
• Strong analytical and troubleshooting skills.
• Ability to conduct literature searches for specific target molecules and reactions; ability to use the literature to design efficient synthetic routes, as well as troubleshoot problematic reactions.
• Thorough understanding of modern analytical and spectroscopic techniques and ability to interpret the corresponding data and spectra.
• Quality-first mindset, which leads to the production of highly pure final products.
• Ability to work independently and efficiently, as well as work across and within groups to support the goals of the company.
• Ability to organize work efficiently, carry out multiple operations in parallel, and successfully complete projects in a timely fashion.
• Excellent written and oral communication skills.

Compensation

The salary range for this role is $75,000-$90,000.

Benefits

LightwaveLogic offers a highly competitive compensation package including stock options, as well as comprehensive benefits including fully paid medical, dental, and vision insurance coverage (employee and family). a generous PTO policy, $500/year(prorated) company contribution to your medical FSA, and a 401K (safeharbor, 4% match).

EEO Statement

Lightwave Logic 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, disability, or protected veteran status.

Great American Restaurants is seeking an experienced Director of Construction Development to join our growing construction team. This on-site role is based out of our support center office in Fairfax, Virginia, with frequent on-site work expected at all new and existing locations. Established in 1974, Great American Restaurants operates thirteen high-volume, upper casual restaurants, an upscale dining location, three artisan bakeries, and a fast-casual BBQ joint in Northern Virginia and Maryland.

With several new locations in progress and more in the works, this new role will contribute to all aspects of the construction and development process, with a strong focus on design and planning.

Key Responsibilities

• Collaborate with architects, engineers, kitchen designers, general contractors, vendors, and internal stakeholders to deliver ground-up builds and major remodels on time and within budget.
• Apply strong technical expertise in construction processes and building design, working with architects, engineers, and trades to build complex, high-quality restaurant environments.
• Review and validate architectural and MEP plans. Identify and address issues prior to mobilization.
• Implement permitting strategy with authorities having jurisdiction (AHJs).
• Partner with internal construction and operations teams to execute facility improvement projects efficiently and effectively.

Minimum Requirements

• Bachelor’s degree in Architecture, Engineering, Construction Management, or related field
• 5+ years of progressively responsible construction project management (hospitality projects preferred)
• Experience managing $10M+ projects
• Knowledge and understanding of restaurant construction processes, food service equipment, facilities management, mechanical systems and procedures, building and health codes, and other applicable regulatory requirements

Why You’ll Love Working Here

• Competitive base salary
• 3 weeks Paid Time Off (PTO) to start plus 6 additional holidays
• Medical, Dental, Vision, Long-Term Disability and Life Insurance
• 401(k) with generous employer match
• Monthly dining card
• Gym and educational reimbursement

We're building safety-enhancing technology for aviation that will save lives. Automated aviation systems will enable a future where air transportation is safer, more convenient and fundamentally transformative to the way goods - and eventually people - move around the planet. We are a team of mission-driven engineers with experience across aerospace, robotics and self-driving cars working to make this future a reality.

As a Supplier Development Engineer at Reliable Robotics, you'll play a critical role in developing and continuously improving all aspects of our mechanical supplier engineering processes to meet design, regulatory, and business requirements (including safety, quality, cost, and on-time delivery). This is a growing team of highly motivated people passionate about delivering quality products and services on time, with unquestionable value. You will be responsible for sourcing, qualifying, and troubleshooting all machining and sheet metal products, conducting design for excellence (DFx) reviews, and developing the processes and infrastructure to help the business scale. The projects you work on will set the foundation for how the business operates for years to come. This is a fantastic opportunity to work in a safety-critical environment that takes automated aviation systems from prototype to production in a hands-on environment.

Responsibilities

• Develop and manage supplier relationships to ensure they meet or exceed manufacturing, testing, inspection, quality, performance, and reliability requirements

• Develop design for excellence (DFx) processes, and conduct reviews to evaluate designs for cost, producibility, inspectability, consistency, adequacy, accuracy, and conformance to requirements

• Develop supplier qualification processes and conduct regular reviews

• Collaborate with design, quality, and certification teams to embed producibility/manufacturability, compliance, and risk mitigation in all phases of product development (e.g., prototype, R&D, certification, and production)

• Develop quality control plans and inspection infrastructure, including dimensional inspection and functional testing

• Develop and ensure compliance with all policies, procedures, quality management systems, and engineering change orders

• Develop processes to ensure accurate, current, and complete documentation (work instructions, inspections, tests, records, etc.) is utilized and maintained

• Lead root-cause analysis and implement timely corrective actions to maintain schedule, quality, and reliability

Basic Success Criteria

• Bachelor's degree in mechanical, aerospace engineering, or a related field of study

• 5+ years of manufacturing, design, and/or testing experience

• 2+ years of experience with computer-aided design (CAD) and Product Lifecycle Management (PLM) software, such as NX and Teamcenter

• Geometric Dimensioning and Tolerancing (GD&T) experience

• Coordinate Measuring Machine (CMM) experience

Preferred Success Criteria

• Experience with CNC machinery (lathe, mill, waterjet, laser cutter, EDM)

• Precision sheet-metal or plastic molding tooling design experience

• Experience with industry or regulatory requirements such as AS9100, CFR 14 CFR 21.137, and/or 14 CFR Part 145

• Research and Development (R&D) or New Product Introduction (NPI) experience

• Previous leadership or management experience

• Prior experience in troubleshooting, repairing, setting up, and operating complex hardware in a safety-critical environment

Our team is passionate about delivering on our commitments, solving hard problems, continuously improving, and helping the business succeed. We are constantly reevaluating our technologies, products, and capabilities. If you are a lifelong learner, you will love this environment. Get in on the ground floor and help us build the company.

This role will be located at our facility in Mountain View, California.

Must be willing to travel 25% of the time.

This position requires access to information that is subject to U.S. export controls. An offer of employment will be contingent upon the applicant's capacity to perform in compliance with U.S. export control laws.

All applicants are asked to provide documentation that legally establishes status as a U.S. person or non-U.S. person (and nationalities in the case of a non-U.S. person). Where the applicant is not a U.S. person, meaning not a (i) U.S. citizen or national, (ii) U.S. lawful permanent resident, (iii) refugee under 8 U.S.C. * 1157, or (iv) asylee under 8 U.S.C. * 1158, or not otherwise permitted to access the export-controlled technology without U.S. government authorization, the Company reserves the right not to apply for an export license for such applicants whose access to export-controlled technology or software source code requires authorization and may decline to proceed with the application process and any offer of employment on that basis.

At Reliable Robotics, our goal is to be a diverse and inclusive workforce. As an Equal Opportunity Employer, we do not discriminate on the basis of race, religion, color, creed, ancestry, sex, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity, gender expression, sexual orientation, age, non-disqualifying physical or mental disability or medical conditions, national origin, military or veteran status, genetic information, marital status, or any other basis covered by applicable law. All employment and promotion is decided on the basis of qualifications, merit, and business need.

If you require reasonable accommodation in completing an application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to

Compensation Range: $132K - $200K

COMMERCIAL DEVELOPMENT MANAGER

COMPANY OVERVIEW

AlpHa Measurement Solutions is a liquid sensor technology platform serving the complex testing needs of water quality, pharmaceutical, laboratory, and industrial markets with an unmatched combination of precision, reliability, innovation, and flexibility. We are a vertically integrated manufacturer, creating thousands of units and processing several hundred orders and shipments each day for customers throughout the world. We approach the market as both an OEM manufacturer and with our own brands: Van London, ANDalyze, and Aurora Scientific Instruments.

WHAT MAKES ALPHA MEASUREMENT SOLUTIONS SPECIAL

At AlpHa Measurement Solutions, we make analytical sensors and instruments that are essential to everyday life. What we do matters; our products are used to test and monitor water quality in industrial, health, and safety applications worldwide. Our sensors are critical for wastewater and drinking water processing, environmental monitoring, pharmaceutical (vaccine) manufacturing, food & beverage supply, power generation, and many other fundamental applications.

Municipalities, multinational organizations, and system integrators rely upon our sensors as critical, consumable components of their systems around the globe. We at AlpHa understand the important role we play in ensuring safe drinking water, clean aqueous environments, and the general health and safety of communities worldwide.

BENEFITS & PERKS

• Medical, Dental & Vision Insurance
• Health Savings Accounts (HSAs)
• Short-Term Disability
• 401k
• Life insurance
• Paid Vacation
• 8 Paid Holidays per year
• Paid Jury Duty Leave
• Recognition and Reward Programs
• Diverse & Inclusive Work Culture

OPPORTUNITY

AlpHa Measurement Solutions has tremendous opportunity to capitalize on new commercial opportunities and recognizes the need to strengthen its Sales & Marketing capabilities to meet increased demand and support continued growth by further penetrating attractive end markets with its differentiated product portfolio. We have an immediate need for a Commercial Development Manager to lead our Houston-based business development team.

Our company has over 100 years of liquid sensing experience and is accelerating growth through its recent acquisition by Enpro Inc. (NYSE: NPO). Enpro is a leading industrial technology company manufacturing high-performance proprietary products for the semiconductor, aerospace, and compositional analysis sectors. Enpro companies employ nearly 4,000 associates globally, while AlpHa's team consists of over 350 employees, including 235 team members in Houston, Texas and 120 in Shanghai, China. We need an organized and energetic Commercial Development Manager who wants to lead a growing team, who is self-motivated to advance the company's goals, and who can take the Sales Team to the next level.

Our global headquarters is conveniently located in Houston at the southwest intersection of I-69 and Sam Houston Tollway, just north of Sugar Land.

This individual will report to the VP of Sales & Marketing.

Classification : Salaried/Exempt, Full-Time, Monday through Friday, 8:00 AM to 5:00 PM, and as required to maintain business momentum.

JOB DESCRIPTION

Position Summary

The Commercial Development Manager (CDM) is responsible for leading new business development execution and commercialization of New Product Introduction (NPI) initiatives within the commercial organization. This role is structured as a hands-on player–coach, directly managing a team of Business Development Representatives and Inside Sales while personally owning select strategic accounts and growth initiatives.

The CDM drives new account acquisitions, target market expansion, and early-stage product commercialization efforts. Reporting to the VP of Sales & Marketing, this role establishes segment-level priorities, ensures disciplined pipeline development, and maintains accountability for both individual and team performance. The CDM partners cross-functionally with Engineering, Marketing, and Operations to align new product launches and market development strategies with commercial execution.

Essential Functions

Reasonable accommodation may be provided to enable individuals with disabilities to perform the following essential functions:

• Lead and develop the business development team, including hiring, onboarding, coaching, performance management, and development of business development and inside sales resources, while establishing clear prospecting standards, pipeline expectations, and measurable activity metrics aligned with company growth objectives
• Lead business development execution from strategy through implementation, maintaining direct involvement in prospecting initiatives, new account acquisition, forecasts, and customer engagements, while driving accountability through regular pipeline reviews and one-on-one meetings
• Act as a hands-on "player coach", personally leading and supporting new account acquisition efforts across emerging markets and new product launches, including strategic prospecting, trade show engagement, networking, and targeted outreach campaigns
• Directly manage and grow a limited portfolio of strategic or high-impact accounts and opportunities, serving as primary commercial lead in customer meetings, negotiations, pricing discussions, and deal execution
• Support new product launches and capitalize on AlpHa's New Product Development team's efforts by effectively penetrating target end markets with AlpHa's differentiated new sensor technologies
• Own and execute the commercial components of the NPI process from market validation through launch, translating competitive analysis, customer requirements, market feedback, and early adopter engagement into actionable product and go-to-market strategies in alignment with Engineering, Marketing, Commercial, and Operations
• Own the business development and NPI forecasting and budgeting processes, including setting annual targets in partnership with Finance, managing group expenses relative to budget, and measuring performance against revenue and margin objectives
• Establish and approve pricing strategies and deal structures for NPI initiatives and strategic opportunities, ensuring alignment with margin objectives, competitive positioning, and customer value propositions
• Design, implement, and continuously improve business development processes, including prospecting strategies, NPI commercialization workflows, opportunity qualification standards, CRM discipline, and pipeline management to ensure consistency and accountability across the team
• Own and execute the regional trade show strategy in partnership with the North America Commercial team, including show selection, budgeting, messaging, staffing, pre-show planning, on-site execution, and post-show follow
• Use data and analytics to drive decisions, leveraging dashboards, and reporting tools (e.g. CRM, Power BI, etc.) to evaluate NPI launch performance, prospecting effectiveness, pipeline health, conversion rates, and team productivity and conduct regular data-driven business reviews with the executive and cross-functional stakeholders
• Collaborate cross-functionally with Engineering, Marketing, Finance, and Operations to ensure successful product launches, seamless new account onboarding, demand planning alignment, and execution of growth initiatives
• Travel as required to coach team members in the field, engage key prospects / customers, represent the company at trade shows and industry events, and gather market and competitive insights to support strategic growth initiatives

Required Key Competencies

• Drive for Results
• Managing and Measuring Work
• Directing Others
• Strategic Agility
• Customer Focus
• Business Acumen
• Dealing with Ambiguity
• Process Management

Required Qualifications and Experience

• Bachelor's Degree required, preferably in a technical field
• Minimum 5 – 10 years of business development leadership experience in a technical / manufacturing environment, with a strong preference for direct experience in water treatment, liquid analytical sensing / industrial process control, or test & measurement industries
• Must have extensive experience leading business development teams, including managing groups remotely or over a large territory
• Must have proven experience driving commercialization of new products, leading NPI processes, and successfully penetrating new or emerging markets in a technical B2B environment
• Must be comfortable working with and driving diverse team members
• Experienced leader with proven results in making authoritative business decisions, executing decisions and accounting for results
• Excellent communication skills (written and verbal) are required
• Experience with communicating technical and complex information concisely and clearly to senior management
• Successful experience utilizing a CRM and an ERP system to manage team sales tasks, pipeline, closing data, and transaction execution
• Must be analytical and data driven with an ability to analyze multiple leading indicators of revenue and pipeline information to direct team
• Must be highly competent in Microsoft Office, with advanced Excel skills and hands-on experience building, analyzing, and interpreting reports and dashboards in Power BI
• Ability to travel up to 50% of the time

*Enpro Inc. is an equal opportunity employer. Legal authorization to work in the United States is required. We will not sponsor employment visas now or in the future for this job.

*This position involves access to information that is subject to U.S. export controls. Any job offer made will be contingent upon the applicant's capacity to serve in compliance with U.S. export controls.

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. 

TheSenior Process Engineer is responsible for designing, developing, optimizing and troubleshooting manufacturing processes in a manner that meets safety, quality and operational performance expectations. This position provides leadership and creativity in the formulation development, process development and optimization, scale up and manufacturing. The key function of this role is to identify and solve problems in the manufacturing process transfer and scale up, and deliver effective, safe and efficient manufacturing processes for parenteral drug products. The Senior Process Engineer is hands-on, able to handle multiple tasks with sound planning and communication and providing training and support to peers.

This role will:

• Analyze organic or inorganic pharmaceutical excipients to determine chemical or physical compatibilities with active drug molecules for the development of stable pharmaceutical product
• Evaluate changes in the composition/stability of pharmaceutical products due to changes in variables such as heat, light, or chemical catalysts for quantitative or qualitative analysis
• Propose and prepare formulations with different excipients or solvents to conduct experiments and analytical testing at laboratory scale
• Propose and develop lyophilization product and process or other complex formulation process such as liposome, TFF and viscous product
• Take an active part in scale-up and technology transfer of newly developed products from R&D to manufacturing
• Identify and order materials required to perform development and manufacturing
• Identify tooling and equipment required to perform development and manufacturing
• Create documents for laboratory/manufacturing operations and quality such as master batch records, study protocols, engineering batch record, process characterization reports, standard operating procedures (SOP), etc. Review these documents for their compliance with cGMP and FDA standards
• Due diligence on manufacturing process design and risk analysis to ensure operation safety, efficiency and quality
• Propose testing procedures for analyzing CQA and coordinate with quality control testing to ensure the quality of finished drug product
• Compile and analyze test information to determine process or equipment operating efficiency or to diagnose malfunctions
• Analyze in-process and release testing results to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA) of the pharmaceutical product
• Maintain ownership of assigned laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed
• Study effects of various manufacturing techniques or packaging configuration on the composition or stability of pharmaceutical product
• Develop, improve or customize equipment, formulas, processes or analytical methods to maintain quality of pharmaceutical product
• Write technical papers or reports or prepare standards and specifications for processes, facilities, products, or tests
• Provide leadership in daily operations, and have employees incorporate these compliance practices into their daily routines
• Lead/support validation activities including equipment validation and process validation
• Lead problem solving and investigate quality events related to formulation process or batch records
• Propose and lead process improvement initiatives to improve operating performance and laboratory safety procedures to ensure compliance with the cGMP and FDA standards
• Lead or participate in root cause analysis and quality event investigation such as OOS and deviations
• Supervise, mentor and develop team members or relevant personnel across departments

This role requires:

• A minimum of three (3) years of experience in pharmaceutical research and manufacturing
• Bachelor’s degree or above in Chemical Engineering, Chemistry, Biology or Pharmaceutical Science
• Experience in sterile manufacturing is preferred
• Experience in lyophilization and terminal sterilization techniques are a plus
• Knowledge of parenteral drug product manufacturing
• Proficient with calculation, data analysis, statistics and applied mathematics

About Us:

Franco Manufacturing Co., Inc. has been a leading international producer of home fashions for over 70 years. Our products include whimsical and stylish bedding, pillows, throws, towels, and accessories for popular licensed properties, including Disney, Hasbro, Nickelodeon, Warner Brothers, and many more. Franco products can be found at major mass market retailers, specialty stores, discount stores, department stores and on-line retailers.

Responsibilities:

In this highly visible position, you will manage and oversee daily order processing operations to ensure orders are entered, reviewed and released accurately and on-time. Duties include:

1. Ensure that inventory and/or product allocation issues are addressed with Planning, Sales, Production Planning, Receiving and/or Distribution management. Ensures accuracy of order confirmation and billing.
2. Manages the order pipeline updating ship windows and planned ship dates to give an accurate shipping forecast. Monitor order status, back orders, and exceptions. Proactively address delays or discrepancies.
3. Manage the on-boarding of new accounts including reviewing account requirements and sales forecast. Communicate requirements with internal teams to ensure that orders can be processed by the required date.
4. Ensures that current routing and compliance requirements are maintained for assigned customers and updates are coordinated with IT.
5. Research compliance charge backs and provide Accounts Receivable with supporting documents to handle disputes. Work with VP Operations to develop processes to avoid re-occuring chargebacks
6. Ensures that all necessary documents are provided to Order Processing to release and batch customer orders. Ensure that assigned ship dates are communicated and routing is set up.
7. Regularly communicate with Sales to ensure they are aware of account and order processing issues.
8. Coordinates with warehouse management to prepare production schedules for reworks and pallet assembly projects.
9. Oversee the flow of customer shipping orders to warehouses in accordance with customer compliance guidelines. Establishes priorities and assists in planning work center capacity and establishing receiving priorities.
10. Maintain NMFC freight class and SCAC codes in operating system.
11. Coordinates with Sales, Production, and Logistics teams and implements process improvements to enhance accuracy, efficiency and customer satisfaction.

Requirements:

• Qualified candidates must have 5+ years’ experience managing a Customer Service or Order Processing team in a high-volume consumer products environment
• Previous experience working with major retail accounts including Walmart, Target, and/or Amazon
• Understanding of customer routing through major retail portals
• Experience building and calculating truck volumes and scheduling shipments
• Hands-on experience managing customer compliance and chargeback resolution
• Strong verbal and written communication skills
• Highly detail-oriented with strong organizational skills
• Computer proficiency in MS Office (Word, Excel, Email) and experience with ERP and WMS systems
• Experience with the Blue Cherry ERP system is a plus

SUMMARY

The Economic Development & Government Affairs Associate is responsible for identifying, evaluating, and advancing real estate economic development tools and assets covered by these tools to leverage expertise in public-private partnerships, incentives, market intelligence, and strategic relationships. This role focuses on maximizing project feasibility, long-term value, and community alignment while supporting the company’s growth and development objectives.

ESSENTIAL DUTIES:

• Develops, assists, and helps with negotiating long-term strategies for deploying economic development tools to assist with development and construction growth plans
• Lead business recruitment and development efforts for the company across different industry sectors.
• Identify existing industries with expansion efforts and manage relationships with local businesses.
• Research community impact on development efforts to ensure business goals are accomplished.
• Support economic research to advance business growth.
• Negotiate business development grants, loans, and investment packages with local, state, or federal government.
• Engage with stakeholders, including government officials, educators, and community leaders to align regional interests.
• Build and maintain relationships with governmental, community, and business leaders to facilitate development projects.
• Utilize economic data, GIS mapping, and market trends to identify prime locations and economic opportunities.
• Oversee, direct, and monitor real estate and site development programs to ensure compliance with company goals.
• Collaborate with internal departments on economic development projects.
• Manage current and future Tax Increment Reinvestment Zone (TIRZ) agreements.
• Lead Municipal Management Districts (MMD) partnerships and Municipal Utility Districts (MUD) and any other special districts or economic development tools
• Actively seek new business opportunities through networking and outreach.
• Participate in town hall meetings, City Council, Planning and Zoning, MPO, State and Federal meetings, non-profits, conferences, workshops and community development events to establish and build business networks.
• Work collaboratively with team members and across departments.
• Other Duties as Assigned.

EDUCATION:

Bachelor’s degree required, with master’s degree (MBA, Economics, Public Policy) preferred. Certified Economic Developer (CEcD) preferred.

EXPERIENCE:

Must have at least ten (10) years in economic development, corporate real estate, business finance, or related roles.

SKILLS:

Must have the following skills and/or abilities:

• Proficient in Windows operating systems and associated software
• High level negotiation skills
• Ability to lead, present to executives or public boards, and manage complex projects
• Experience working with city, county, state, and federal agencies
• Strong oral and written communication skills
• Ability to work with community and governmental leaders effectively
• Knowledge of trends, developments, and techniques in the field of economic development

LICENSES/CERTIFICATIONS:

Must have a current driver’s license and a satisfactory driving record.

PHYSICAL REQUIREMENTS:

Must be able to perform the following physical activity on a frequent to constant basis:

• Sit for long periods of time while gathering, updating, and validating vendor or supplier cost information or performing other related activities.
• Lift 10–20 lbs. of files, plans, office supplies, or similar items.
• Constantly uses fingers and hands when dialing/answering the telephone and operating a computer or other office machinery, such as a copy machine, scanner, and computer printer.
• Ability to hear average or normal conversations and receive ordinary information through verbal communications in person or detect objects in and around job site over the telephone.
• Average, ordinary visual acuity necessary to prepare or inspect documents; operate a computer or other office machinery; or.
• Walk short distances on slippery, even, and/or uneven surfaces.
• Stand, bend, stoop, kneel, crouch, twist, turn, or crawl.

WORKING CONDITIONS:

• Majority of work is performed in an office atmosphere located inside a building, with building inspections as needed.
• May require infrequent job site visits involve performing work in outdoor weather conditions with exposure to extreme cold, heat, and noise depending upon project site.
• Travel locally and between cities where development is in progress will be expected.

OTHER REQUIREMENTS:

Must be able to:

• Adhere to the highest standards of ethics, integrity, professionalism, and discretion.
• Project a courteous, professional and positive approach with clients, subcontractors, employees, and authorizing agencies while providing prompt, efficient, and accurate assistance.
• Follow and exchange basic instructions, information, and guidelines.
• Direct and instructs Sub-Contractors effectively with a leadership style that is firm, fair, consistent, and goal oriented.
• Nurture a working environment which encourages employee loyalty, longevity, and satisfaction.
• Creates a culture of customer satisfaction.
• Make independent decisions based on experience or knowledge with minimal supervision.
• Participate in training and development opportunities offered to maintain construction-related software and safety knowledge.
• Communicate and comprehend instructions/directions in accordance with safety requirements, which necessitate no language barriers exist between employees and supervisors.
• Adhere to and perform functions according to company and OSHA safety guidelines.
• Wear personal protective equipment as required such as steel toed shoes, gloves, safety glasses, hearing protection, hard hat, vest, and the like while conducting job site visits.
• Maintain regular, timely, and predictable attendance.