Agile Iterative Development Methodology Jobs in Usa

11,345 positions found — Page 14

Business Development Officer II
✦ New
Salary not disclosed
Dallas, TX 15 hours ago
Business Development Officer II

Texas Capital is built to help businesses and their leaders. Our depth of knowledge and expertise allows us to bring the best of the big firms at a scale that works for our clients, with highly experienced bankers who truly invest in people's success today and tomorrow.

While we are rooted in core financial products, we are differentiated by our approach. Our bankers are seasoned financial experts who possess deep experience across a multitude of industries. Equally important, they bring commitment investing the time and resources to understand our clients' immediate needs, identify market opportunities and meet long-term objectives. At Texas Capital, we do more than build business success. We build long-lasting relationships.

Texas Capital provides a variety of benefits to colleagues, including health insurance coverage, wellness program, fertility and family building aids, life and disability insurance, retirement savings plans with a generous 401K match, paid leave programs, paid holidays, and paid time off (PTO).

Headquartered in Dallas with offices in Austin, Fort Worth, Houston, Richardson, Plano and San Antonio, Texas Capital was recently named Best Regional Bank in 2024 by Bankrate and was named to The Dallas Morning News' Dallas-Fort Worth metroplex Top Workplaces 2023 and GoBankingRate's 2023 list of Best Regional Banks.

The Business Development Officer II (BDO) is accountable to work across the firm to identify opportunities that deliver the entire suite of Texas Capital products and services to prospective clients that meet their financial needs. This role focuses on generating sales opportunities for the inset market banking teams by routinely making agenda-based calls for prospects, partnering with firm leaders to develop the sales strategy, and help lead marketing efforts for these markets. The BDO assists with sales processes including prospect prioritizing, initial contact and pursuit strategy, identification of fit and opportunity, due diligence and proposal development, and overall management of new customer acquisition for the prospects in his/her portfolio.

BDO team members support our focus on building strong relationships balanced with a strong risk mitigating and compliance-driven culture which firmly establishes those disciplines as critical to the success of our business development efforts. They are accountable for making sound risk decisions commensurate with the business unit's risk appetite and all risk and compliance program requirements.

Responsibilities:

  • Ensure appropriate prospect coverage through disciplined calling efforts, understanding the prospect's strategic and financial objectives, and working across all TCB product partners to identify appropriate opportunities to develop the bank's relationship with the prospect and sell the whole bank.
  • Develop and maintain a robust prospect acquisition pipeline.
  • Effectively transfer opportunities developed to Relationship Managers (RM)
  • Embrace the TCB Sales Excellence process to ensure appropriate prospect coverage and align with TCB product partners on delivering banking solutions to accelerate new client acquisition.
  • Possess a natural disposition to be focused on achieving production goals and calling metrics.
  • Keep abreast of the latest financial and banking product knowledge, financial markets, and relevant regulations.
  • Stay current on business trends to enhance relevancy with prospects covered.
  • Surface issues and provide feedback to appropriate corporate functional leaders for visibility and resolution.

Qualifications:

  • Bachelor's degree in business, finance, or related field/experience
  • Minimum of five years commercial banking experience preferred with focus on middle market and corporate clients or other relevant business development/sales experience.
  • Ability to perform in an exciting and transformative environment.
  • Must have excellent interpersonal and communications skills, both verbal and written, with ability to communicate with all levels of employees, management, internal partners, and clients.
  • Strong organizational skills; ability to identify and solve problems/issues; ability to manage multiple priorities/workstreams.
  • Proficient in Salesforce and MS Office products (Teams, Word, Excel, PowerPoint)

The duties listed above are the essential functions, or fundamental duties within the job classification. The essential functions of individual positions within the classification may differ. Texas Capital Bank may assign reasonably related additional duties to individual employees consistent with standard departmental policy. Texas Capital is an Equal Opportunity Employer.

Not Specified
RN Professional Development Specialist - Surgical & Women's Services
✦ New
Salary not disclosed
Dayton, OH 15 hours ago
Nursing Professional Development Specialist

Kettering Health Miamisburg | Miamisburg | Full-Time | Varied Shift

Responsibilities & Requirements

Job Summary:

The Nursing Professional Development Specialist (NPDS) is a professional nurse who contributes to the learning and ethical practice development of all nursing employees.

Responsibilities of the role include serving as an educator, career coach, mentor and leader within the organization.

The NPDS assists, facilitates and guides the development of nursing employees beginning with initial orientation and continuing throughout the employment of the individual.

The NPDS serves as a resource to leadership for the implementation of education programs, evidenced based practice and outcomes evaluation.

The Nursing Professional Development Specialist systematically enhances the quality and effectiveness of nursing professional development practice.

The delivery of nursing care within the Kettering Health Network reflects the missions, vision, values and philosophies, of the organization and nursing departments.

The Nursing Professional Development Specialist reports to a Nurse Manager or a Nursing Director.

Educational Requirements:

  • Licensed in the state of Ohio as a Registered Nurse
  • Graduate of an accredited school of nursing (NLN, ACEN, or CCNE)
  • Bachelor of Science in Nursing required
  • Nursing related Master's degree required within four years of hire
  • Certification in specialty area required
  • BLS required
  • Minimum of three years clinical RN experience
  • OB/Labor & Delivery experience required
Preferred Qualifications

Preferred:

  • Experience as NRP Instructor
  • Experience with professional development programs, such as Professional Ladder, Nurse Leader Fellow, CE development
  • Experience as Labor and Mother Baby RN Preceptor
  • Strong intrapersonal skills
  • Proficient in utilizing computer software
  • Experience with an electronic learning management system preferred
Overview

Kettering Health is a not-for-profit system of 13 medical centers and more than 120 outpatient facilities serving southwest Ohio. We are committed to transforming the health care experience with high-quality care for every stage of life. Our service-oriented mission is in action every day, whether it's by providing care in our facilities, training the next generation of health care professionals, or serving others through international outreach.

Not Specified
Associate Business Development Manager
✦ New
Salary not disclosed
Boston, MA 15 hours ago
Associate Business Developer

We are seeking a dynamic Associate Business Developer to join our Americas Institutional Group (AIG) within the Client Platform Institutional Sales team focusing on the institutional market and investment consultants. The opportunity set will include Corporate and Public Pensions, Endowments & Foundations, and Hospital systems. The Associate Business Development Manager will be based out of our Boston or New York office and will identify institutional opportunities across the eastern seaboard.

Responsibilities

The Associate Business Development Manager will conduct thorough market research to identify new business opportunities and understand market trends, developing and maintaining deep relationships with new and existing clients and consultants, ensuring the highest levels of client service. The ideal candidate will develop and implement business development strategies tailored to the institutional marketplace, aligning with Wellington's strategies and priority products. The candidate will be highly proactive, creative, entrepreneurial, team oriented, and collaborative. They will work in partnership with Business Development Managers to grow and defend the business in these regions. This role will also work in close partnership with internal Relationship Management, Consultant Relations, Product Management and Investment teams to drive exceptional growth.

Essential Skills

The following skills are required for the role:

Passion for Sales and Investments The ideal candidate should have a minimum of 5-10 years of experience within the investment industry and will possess a deep understanding of the investment landscape in the Americas Institutional market. They will demonstrate a strong track record in sales across alternatives, equity, and fixed income products. This role requires a strategic thinker with a passion for building and nurturing client relationships, driving business growth, and delivering exceptional service to institutional clients.

Highly Collaborative-This role requires a great deal of teamwork and collaboration across Wellington. The successful candidate will enjoy being an individual contributor within a highly collaborative team and embrace the benefits of overlapping lines of idea generation. The ideal candidate will build strong, trusting relationships with clients, prospects and consultants, and industry contacts as well as internal colleagues and recognize the benefits of diverse perspectives.

Exhibits a Growth Mindset-The flexibility and openness to continue learning, evolving and growing is required. The successful candidate will take a creative approach to think about innovation and the future of the Americas Institutional business.

Other Qualifications

A successful candidate will also have the following qualifications:

  • Proven aptitude for sales, paired with strong analytical skills and a strategic mindset, enabling effective execution of both analyst and business development manager capacities.
  • Willingness to travel within the US.
  • Strong interpersonal skills and experience in a collaborative, team-based, results-oriented environment.
  • Independence of thought, intellectual curiosity, and entrepreneurial nature.
  • Strong work ethic and attention to detail; strategic and tactical thinker with solid organizational skills.
  • Ability to communicate (verbally and in writing) clearly with conviction and contribute to an open dialogue, comfortable presenting.
  • Possess maturity, polish, and personal presence.
  • CFA/CAIA or advanced degree is strongly preferred.

Not sure you meet 100% of our qualifications? That's ok. If you believe that you could excel in this role, we encourage you to apply and welcome a chance to review your background. We are dedicated to building and maintaining a diversified workforce and considering a broad array of candidates with a variety of skill, workplace experiences, and backgrounds.

As an equal opportunity employer, Wellington Management ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, sex, sexual orientation, gender identity, gender expression, religion, creed, national origin, age, ancestry, disability (physical or mental), medical condition, citizenship, marital status, pregnancy, veteran or military status, genetic information or any other characteristic protected by applicable law.

If you are a candidate with a disability, or are assisting a candidate with a disability, and require an accommodation to apply for one of our jobs, please email us at .

At Wellington Management, our approach to compensation is designed to help us attract, inspire and retain the best talent in our industry. We strive to pay employees fairly and competitively across all levels and roles. Our approach to compensation considers all aspects of total compensation; all employees are eligible to receive salary, variable compensation, and benefits. The base salary range for this position is:

USD 80,000 - 150,000

This range takes into account the wide range of factors that are considered when making compensation decisions, including but not limited to skill sets; role; skills and experience; certifications; and education. This range is an estimate, and further details on salary and total compensation aspects will be shared with candidates during the recruitment process.

Base salary is only one component of Wellington's total compensation approach. Other rewards may include a discretionary Corporate Bonus and/or Incentives, if eligible. In addition, we offer a comprehensive and high value benefit package to meet the unique needs of our employees and their families, and we are committed to fostering a flexible work environment that enables employees to thrive personally and professionally. Examples of our benefits include retirement plan, health and wellbeing, dental, vision, and pharmacy coverage, health savings account, flexible spending accounts and commuter program, employee assistance program, life and disability insurance, adoption assistance, back-up childcare, tuition/CFA reimbursement and paid time off (leave of absence, paid holidays, volunteer, sick and vacation time).

We believe that in person interactions inspire and energize our community and are essential to our culture. In support of this commitment, our employees work from our offices 4 days a week with flexibility to work remotely 1 day a week. We believe that this approach ultimately supports our mission to deliver investment excellence to our clients and their beneficiaries over the long term.

Not Specified
Land Use and Development Associate Attorney
Salary not disclosed

Holtzman Vogel is seeking to hire a Land Use and Development Associate Attorney with 3+ years of legal experience with land use, real estate development and/or environmental law. This position can be based in our Tallahassee or Miami office.

You will be working with partners on complex land use and development issues, analyzing land use and zoning statutes and ordinances, and working with clients to finance, acquire, plan, develop, litigate, and otherwise navigate the real estate development process.

Requirements:

  • 3+ years of experience as an attorney in land use, real estate development of environmental law.
  • Experience working with state and local governments preferred.
  • Should have a strong interest in real estate development.
  • Must be self-motivated.
  • Must have excellent verbal and written communication skills.
  • Must have strong academic credentials.
  • Must be client-service minded.
  • Must have great attention to detail.
  • Must have sound judgment with the ability to prioritize and work as a team player under the pressure of deadlines and client needs.

About Holtzman Vogel

Holtzman Vogel protects the highest profile voices in business, politics and advocacy. For 25 years, Holtzman Vogel has counseled Fortune 500 companies, non-profits, high-net-worth individuals, trade associations, PACs, campaigns, state legislatures and lobbyists on complex legal and regulatory matters. The firm's stunning client record has made it among the most sought-after firms in the nation in high-stakes challenges. For more information, please visit

Not Specified
Training And Development Consultant
✦ New
Salary not disclosed
Dallas, Texas 1 day ago

Job Description:

Job Title: Automotive Training and Development Consultant

Duration: 06 Months

Location: Dallas, Tx

This position is responsible for analysis, research, development and delivery of manufacturing processes and technical launch training with on-site support to OEM vehicle assembly plants in the US, Canada and Mexico.

Roles and responsibilities include:

• Provide on-site training and support at each of the OEM vehicle assembly plants

• Instruct and consult plant process and repair personnel to improve their understanding of the vehicle and its highly intricate and interconnected systems and subsystems

• Present and demonstrate efficient and effective methods of diagnosing and correcting vehicle assembly, vehicle electrical systems and sub-system deficiencies

• Conduct root cause analysis to accurately identify the cause(s) of assembly and vehicle deficiencies

• Act as the training liaison between product/manufacturing engineering and general assembly by creating, designing and developing training materials related to vehicle assembly process, electrical harness manufacture, vehicle electrical system architectures and schematics

• Communicate and share lessons learned, developed training materials and information gathered in support of one plant project with remaining plants on a timely basis

• Analyze and identify future training needs for each of the OEM vehicle assembly plants

• Support and participate in plant launch meetings and provide training reports to Raytheon management, the OEM management and OEM launch teams

• Interface with engineering, component suppliers and vendors to validate and develop training materials for the manufacturing process, vehicle and vehicle electrical sub-systems prior to the Start of Regular Production (SORP)

• Research and compile manufacturing processes and technical information to be included in training course materials, such as, but not limited to engineering schematics, work in process service information, engineering documents, engineering math data and manufacturing reports

Required Skills:

• Minimum four years of experience as an automotive instructional designer, training developer, automotive instructor and/or manufacturing instructor

• Demonstrated knowledge of automotive systems from an advanced diagnostics perspective

• Demonstrated knowledge of OEM manufacturing tracking and reporting systems

• Demonstrated knowledge of OEM manufacturing dynamic vehicle testing systems

• Ability to develop professional training materials using pre-launch documents

• Ability to read and interpret a digital multimeter, OEM diagnostic scan tool and other automotive related diagnostic test equipment

• Ability to effectively conduct one-on-one and group presentations Ability to interpret early engineering level electrical schematic diagrams

• Ability to read OEM supplier electrical harness prints

• Strong working knowledge of Microsoft Office

• Extensive travel flexibility. Upward of 75% travel, depending upon launch

• Ability to work independently without supervision

• ASE certifications

• Demonstrated presentation skills delivering process and technical training

• Automotive technical assistance center experience

Required Education:

• Associate's degree or Certificate in Automotive Technology, engineering or other related discipline

• High school diploma with eight years of experience as an automotive instructional designer, training developer, automotive instructor and/or manufacturing instructor may be considered in lieu of an associate's degree

Work Environment:

• Work is performed in both classroom and plant settings. Working in plant areas may involve exposure to various automotive fumes, fluids, noise, smells, sharp edges and bump hazards that require continuous use of personal protective equipment, i.e., safety glasses, gloves, and head protection

• Classroom work may involve standing, sitting, walking, occasional lifting (overhead, waist level) from floor, bending, frequent near vision use for reading and computer use

• Physical Requirements: While performing the duties of this position, the employee is frequently required to sit, stand, bend, kneel, stoop, communicate, reach, and manipulate objects

• Duties may involve moving materials weighing up to 35 pounds on a regular basis such as automotive components and equipment, as well as papers, files, boxes, computers, etc. Less frequent requirements for moving materials weighing over 35 pounds do exist with the assistance of lifting and moving equipment, i.e., hoists and lift tables

• Manual dexterity and coordination are required over 70% of the work period while working in the plant areas as well as operating equipment such as computer keyboard, monitor, projector, calculator, printer, and standard office equipment

internship
Chief Attorney Development Officer
✦ New
Salary not disclosed
Washington, DC 9 hours ago

Chief of Attorney Development & Engagement

Locations: San Francisco | New York | Los Angeles | Washington, DC

Compensation: $375,000–$425,000 base + annual bonus


We are conducting a highly confidential search on behalf of a premier international law firm for a Chief of Attorney Development & Engagement. This is a rare C-suite leadership opportunity for a senior legal talent executive or former practicing attorney with deep experience building and scaling attorney development, engagement, training, mentoring, performance management, and culture initiatives across a large, multi-office law firm platform.


This individual will play a critical role in shaping the attorney experience across a global organization of 700+ lawyers by leading strategy around:


  • Attorney learning, education, and training
  • Leadership development and career pathing
  • Performance management and promotion infrastructure
  • Attorney engagement and opportunity initiatives
  • Mentorship, coaching, and retention strategy
  • Alumni relations and brand-building efforts
  • CLE/MCLE compliance and professional responsibility training
  • Pro bono engagement and strategic alignment


The ideal profile will bring:


  • 10+ years of experience in attorney development, talent strategy, professional development, or legal learning leadership within a sophisticated law firm environment
  • Strong understanding of large law firm practice groups and attorney success models across transactional, litigation, regulatory, and IP practices
  • The credibility and judgment to partner with executive leadership, firm management, and board-level stakeholders
  • A modern, innovative mindset around legal talent, leadership development, culture, and GenAI-enabled learning strategies
  • Exceptional discretion, executive presence, and the ability to lead across offices and constituencies


A JD is strongly preferred, and this role is based in one of the firm’s major U.S. offices with an in-office expectation and some travel. This is an exceptional opportunity to step into a visible, enterprise-wide role at a firm known for strong client service, forward-thinking leadership, and a collaborative cross-disciplinary culture.

Not Specified
Account Development Manager
Salary not disclosed
Birmingham, AL 4 days ago

National Account Development Manager


We are a rapidly expanding aesthetic company that offers its employees a truly entrepreneurial experience. This position provides the ability to work as a practice builder with key national accounts and creatively grow partnerships. The company offers amazing support tools that make the position an exciting business-building opportunity on a daily basis. Join our team of highly motivated executives and experience the thrill of being part of a leader in the medical skincare industry.


The company, Marini SkinSolutions, was founded in 1994 and is a recognized leader and innovator in skincare that is committed to continually expanding and improving the professional skincare market. MSS's two primary focuses are to provide innovative technologies that deliver proven measurable results and an unwavering commitment to the ongoing success of our customers.


We believe the National Account Development Manager position to be crucial for our growth strategy. Our support and focus on this role is our number one priority.


We are looking for candidates who want to make a career in the medical skincare industry and have the desire to be part of a dynamic sales atmosphere. We offer growth opportunities within the national account category, so there will continually be new challenges to strive toward. If you are interested in a career, not just a paycheck, then check this out:


1. Training and Development: To begin, you will be put through a highly interactive training course from your home office by our experienced education team. You will be required to master our state-of-the-art CRM system, which is one of many tools provided for your success.


2. National Account Development: Focus on building and nurturing partnerships with key national accounts. Research and identify additional potential national account partnerships that align with our business objectives to enhance growth.


3. Business Consultation: You will be the primary consultant for your national accounts, managing post-sales support, customer product training, and ongoing relationship management. Your role will involve providing actionable insights to help these accounts effectively grow their business with our products.


4. Sales Strategy: Develop actionable ideas to drive growth for your accounts, ensuring that sell-through of products remains your top priority. Collaborate with accounts to brainstorm innovative strategies for enhancing their sales.


5. Routing and Monthly Cycle Visits: Plan and execute regular routing and monthly cycle visits to maintain strong relationships with your national accounts. Ensure consistent engagement and support while assessing account performance, managing processes, and identifying opportunities for growth.


6. Performance Metrics: You will be accountable to achieve monthly and quarterly targets, with success measured through bonuses and commissions that have no cap.


7. Process Management: Implement and manage processes that facilitate the growth of your accounts, ensuring that all initiatives align with company goals and contribute to overall success.


8. Business Analysis: Analyze your business needs weekly to ensure satisfaction among key accounts, enabling you to proactively address their needs and challenges.


9. Dynamic Presentations: You will need to have the ability to effectively present products and business ideas to engage and educate clients.


10. Travel Opportunities: The position offers the exciting ability to travel outside of your territory, including trade shows and medical conferences that are required to support your growth and the growth of your accounts.


We offer an exceptional compensation and benefits package. The competitive base salary plus a NO-CAP highly attractive commission structure, which is geared towards both base and new business development, is outstanding. In addition to this, we also have an annual performance-based plan. If you like the opportunity to earn more all year long, we have a structure you will find motivating and exciting! We offer a full benefit plan which includes: medical, dental, vision, group life, 401K match, paid holidays, and PTO. We also offer a monthly expense reimbursement which includes a car allowance, mileage reimbursement, as well as normal expenses.


This position is for a National Account Development Manager, and candidates must be willing to travel to meet the needs of our key national accounts. Your strong ability to manage processes and focus on account growth will lead to your success.


Are you ready for a career in the skin care industry? Start here and apply today . An HR representative will reach out to you directly. We look forward to hearing from you and thank you for your interest in Marini SkinSolutions.

Not Specified
Technical Fellow of Research & Business Development Advanced Manufacturing & Additive Technologies
🏢 YBI
Salary not disclosed
Youngstown, OH 3 days ago

Organization: YBI

Location: Youngstown, Ohio 

Employment Type: Full-time

Reports To: Chief Manufacturing Officer


Position Overview

YBI is seeking a highly motivated Technical Fellow of Research and Business Development to support YBI’s advanced manufacturing and additive manufacturing initiatives, with a primary focus on supporting the activities of the Youngstown Innovation Hub for Defense and Aerospace.


This position will report directly to YBI while playing a key role in advancing the Innovation Hub’s mission to accelerate additive and advanced manufacturing technologies for defense, aerospace, and industrial applications. The role bridges applied research, federal program development, regional supply-chain engagement, and the development of shared-use, fee-for-service technical services that support manufacturers across Northeast Ohio and the broader Midwest.


Key Responsibilities

Business Development, Commercialization & Innovation Hub Support

• Identify, pursue, and develop business development opportunities aligned with YBI’s advanced manufacturing strategy and the Youngstown Innovation Hub’s defense and aerospace focus.

• Support commercialization and technology transition efforts that move innovations from TRL/MRL development into pilot and production environments.

• Engage OEMs, tier suppliers, foundries, tooling and mold shops, and additive manufacturing service providers throughout Northeast Ohio and the Midwest.

• Represent YBI in engagements with industry partners, government agencies, academic institutions, and regional economic development organizations.


Shared-Use & Fee-for-Service Program Development

• Lead the design, launch, and expansion of YBI’s internal fee-for-service and shared-use technical services, in coordination with Innovation Hub activities.

• Develop service offerings, engagement models, and pricing strategies for reverse engineering, 3D scanning and metrology, rapid prototyping, additive manufacturing, and mold/tooling design.

• Align service capabilities with regional manufacturing needs, workforce development priorities, and defense supply-chain requirements.

• Support utilization of YBI and Innovation Hub equipment and facilities by industry partners, small businesses, and startups.


Grant Writing & Federal Program Development

• Lead and support competitive proposals for SBIR/STTR, Department of Defense, and manufacturing-focused federal funding programs.

• Integrate YBI capabilities, Innovation Hub assets, and sustainable revenue models into grant proposals and long-term program strategies.

• Coordinate proposal development across YBI staff, technical teams, academic partners, and administrative stakeholders.


Research, Technical & Market Analysis

• Conduct applied research and market analysis related to additive manufacturing, advanced materials, and hybrid manufacturing processes.

• Support applied R&D, demonstration projects, and pilot programs in metal and ceramic additive manufacturing.

• Evaluate manufacturability, scalability, cost, and quality considerations for transitioning technologies into production.

• Prepare technical reports, white papers, and sponsor-facing deliverables.


Required Qualifications

• PhD preferred (Master’s degree with significant relevant experience will be considered).

• Demonstrated experience in federal grant writing, particularly SBIR/STTR programs.

• Strong applied research and technical analysis capabilities.

• Working knowledge of additive manufacturing and 3D printing technologies.

• Excellent written and verbal communication skills.


Preferred / Bonus Qualifications

• Experience working with or supporting programs for the U.S. Department of War

• Experience building or managing shared-use, fee-for-service, or applied research service models.

• Familiarity with Northeast Ohio and Midwest manufacturing supply chains, including metal additive manufacturing, 3D-printed ceramics, castings, foundry operations, mold design, tooling, and hybrid manufacturing.

• Experience supporting technology transition, scale-up, or manufacturing readiness initiatives.


Why Join YBI

• Opportunity to work directly for YBI, a national leader in advanced manufacturing innovation.

• Direct role in supporting the Youngstown Innovation Hub for Defense and Aerospace.

• Access to state-of-the-art additive manufacturing, scanning, and prototyping capabilities.

• Collaborative environment connecting startups, manufacturers, academia, government, and workforce partners.

• Meaningful impact on defense, aerospace, and industrial supply chains in Northeast Ohio and the Midwest.


Not Specified
Director Process Development and Manufacturing, CMC
Salary not disclosed
Durham, NC 3 days ago

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. 

 

Not Specified
Vice President of Business Development
Salary not disclosed
Morristown, NJ 3 days ago

Position Overview

The Vice President of Business Development is responsible for driving new business growth and strategic partnerships for the agency. This role leads the identification, pursuit, and acquisition of new pharmaceutical, biotech, and healthcare clients while strengthening the agency’s market presence and revenue pipeline. The VP will report to the CEO and collaborate with executive leadership, strategy, and creative teams to develop compelling solutions that address client needs and support long-term agency growth.


NOTE: Candidates in the TriState Area (NJ/NYC/Local PA) are highly preferred.


Key Responsibilities


Business Growth & Revenue Generation

  • Identify, pursue, and secure new client opportunities across pharmaceutical, biotech, and healthcare sectors
  • Develop and manage a robust pipeline of prospective clients and partnerships
  • Lead RFI/RFP responses and pitch development with cross-functional teams
  • Meet or exceed annual revenue and new business targets

Client Acquisition & Relationship Building

  • Build and maintain relationships with senior marketing and commercial leaders within pharma and life sciences organizations
  • Represent the agency at industry conferences, networking events, and client meetings
  • Develop long-term strategic partnerships that generate sustainable revenue growth

Strategic Leadership

  • Partner with executive leadership to define growth strategy and priority target accounts
  • Provide market intelligence on industry trends, client needs, and competitive positioning
  • Collaborate with strategy, creative, medical, and account teams to shape compelling client solutions

Pitch & Proposal Leadership

  • Lead the development of pitch strategies and storytelling that highlight the agency’s capabilities
  • Coordinate internal teams to produce high-impact presentations and proposals
  • Guide contract negotiations and onboarding of new clients

Market Development

  • Identify emerging opportunities in digital health, biotech launches, patient engagement, and omnichannel marketing
  • Strengthen the agency’s reputation within the healthcare marketing ecosystem


Qualifications

  • 5+ years of business development, sales, or client growth experience in pharmaceutical, biotech, or healthcare marketing/advertising
  • Proven track record of winning and growing multi-million-dollar client relationships
  • Deep understanding of the pharma commercialization and marketing landscape
  • Experience leading agency pitches and RFP processes
  • Strong executive presence and relationship-building skills
  • Excellent presentation, negotiation, and strategic thinking abilities
  • Bachelor’s degree required; MBA or advanced degree preferred


Key Success Metrics

  • Annual new business revenue generated
  • Number and quality of new client relationships established
  • Pitch win rate and pipeline growth
  • Strategic partnerships developed within the pharma ecosystem


We offer a competitive compensation package, health benefits/perks, discretionary annual bonus, 401(k) plan with 50% match, and opportunities for growth.


NPG Health is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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