Chs Hiring Process Jobs in Usa

Position: Senior Business Process Owner

Location: San Antonio, TX

Targeted Start Date: 04/06/26

Duration: 12 Month

Working Hours: M-F 8-5

Interview Process: 2 rounds of virtual interviews

REQUIRED SKILLS AND EXPERIENCE

• 6+ years of total professional experience within a call center or claims environment, with demonstrated exposure to process improvement initiatives

• At least 2 years of recent experience (most recent roles) in a process improvement, process ownership, or business process-focused role

• Experience supporting, analyzing, and improving operational processes (end‑to‑end exposure preferred)

• Working knowledge of contact center technologies such as Workforce Management tools, ACD platforms, or speech/interaction analytics tools (e.g., Gridspace)

• Hands‑on experience with process mapping, process modeling, and documentation

• Exposure to Lean, BPM, Six Sigma, or similar continuous improvement methodologies Experience developing or supporting KPIs, performance monitoring, and basic risk/control management

NICE TO HAVE SKILLS AND EXPERIENCE

• Insurance designations (AIC, CPCU, AIS)

• Leadership or people‑mentoring experience

• Property and/or auto claims experience Lean Six Sigma certification

JOB DESCRIPTION

Insight Global is searching for a Business Process Owner Senior to support a large financial services client based out of San Antonio, TX.

They will optimize, and transform contact center processes. This role partners cross‑functionally to align process strategy with enterprise experience goals, drives data‑backed process improvements, manages risk and controls, and leads continuous improvement initiatives. The ideal candidate brings strong process ownership, change leadership, and contact center expertise to deliver measurable business impact beyond traditional operations support.

Description:

Title: Development Process Engineer

Duration: 12 Months

Location: St Paul, MN 55117

Education:

Bachelor of Science in Engineering or Technical Field, an equivalent combination of education and work experience

Duties: Establish processes based on product specifications, evaluate process and design alternatives based on Design for Manufacturability principles, understand principles of Cost of Goods Sold, manage program compliance with Quality Control requirements (i.e. Design Control, Process validation etc.), understand IP issues relative to processes being developed, maintain knowledge of new developments in manufacturing and design technologies, understand work environment issues (i.e. OSHA regulations, etc.), support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements, Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

Primary Responsibilities:

Run design of experiments (DOE) studies to characterize processes to improve yield and efficiency

Coach, mentor, and provide guidance to technicians, trainers, and operators

Manage projects which include new production equipment, process development/improvements and cost reductions while supporting new product introductions

Conduct equipment qualifications and process validations

Improve product quality, labor efficiency, and throughput through the use of Lean manufacturing concepts and root cause investigation tools (e.g. DMAIC)

Coordinate the design, procurement, build, and debug of tooling, machinery, and test equipment

Work cross functionally with R&D, Finance, Quality and Operations to define process inputs and outputs

Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Ensure compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications:

Bachelor’s Degree in Chemical, Industrial, or Mechanical Engineering, or other related discipline

5+ years manufacturing engineering experience in medical device or related industry, including working on and documenting process improvement initiatives

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

Previous experience working in a highly matrixed and geographically diverse business environment

Strong analytical, problem solving, and project management skills

Strong organizational and follow-up skills, as well as attention to detail

Individual should be innovative, resourceful, and work with minimal direction

Individual should have excellent organization, problem solving, communication, and team leadership skills

Proficient with MS Office (Word, Excel, Outlook, PowerPoint)

Preferred Qualifications:

Medical device experience

Previous close interface with R&D preferred

Previous delivery system experience in design and driving yield improvements, reducing cost, while increasing capacity

Lean 6 Sigma Green or Black Belt certification

We're seeking a knowledgeable and detail-oriented Heat Treat Process Engineering Supervisor to lead and support all aspects of the heat treatment operations with a focus on quality, compliance, and continuous improvement.

POSITION SUMMARY:

The Heat Treat Process Engineering Supervisor serves as a technical expert responsible for ensuring the proper thermal processing of materials to meet metallurgical and production requirements meeting all CQI-9 requirements. This role includes overseeing furnace operations, audits, documentation, process control, equipment maintenance, and continuous improvement initiatives.

The ideal candidate will have strong metallurgical knowledge, heat treat process experience, the ability to troubleshoot equipment and process issues, and the ability to manage compliance in a dynamic manufacturing environment. This role has direct supervisory responsibility for Lab Technicians, including scheduling, performance management, training, and ensuring compliance with laboratory testing standards and metallurgical validation requirements.

ESSENTIAL DUTIES (Complete):

• Oversee and manage daily heat treat operations including carburizing, hardening, tempering, and stress relieving
• Ensure compliance with AIAG CQI-9: Heat Treat System Assessment (HTSA) and other applicable standards
• Implement and maintain heat treat process control plans per AIAG guidelines
• Conduct and lead CQI-9 self-assessments, audits, and ensure closure of gaps and non-conformances
• Ensure proper setup, calibration, and operation of furnaces and quench systems
• Monitor thermal cycles and maintain control charts, pyrometry data, and process records per CQI-9
• Support system accuracy tests (SAT), temperature uniformity surveys (TUS), and instrumentation calibration activities
• Ensure all documentation meets internal and customer-specific AIAG compliance requirements
• Collaborate with Engineering, Maintenance, and Quality to address process improvements and problem-solving
• Perform metallurgical inspections including hardness testing and microstructure verification
• Provide technical guidance to operators and maintenance personnel on best practices
• Develop and optimize heat treat process parameters including atmosphere control, quench severity, and thermal cycle design to meet metallurgical and dimensional requirements
• Atmosphere verification (Carbon Potential, Dew Point, etc.)
• Distortion Mitigation Strategy
• Develop, implement, and maintain training programs to ensure team competency on heat treat systems and compliance
• Lead root cause analysis and corrective action efforts for heat treat-related non-conformities
• Utilize Lean Six Sigma principles to drive cost reduction, efficiency, and quality improvements
• Maintain proper traceability and process documentation for internal and external audits
• Provide technical direction for furnace troubleshooting, repair validation, and upgrade initiatives in coordination with Maintenance
• Perform other duties as assigned or required in support of production and quality goals
• Directly supervise Lab Technicians, including daily work assignments and workload balancing
• Approve timecards, PTO, and manage attendance
• Perform other duties as assigned or required in support of production and quality goals

CORE COMPETENCIES:

• Action oriented: Demonstrates ownership in solving process and compliance issues
• Self-Motivated: Demonstrates ability to take initiative and drive to achieve results. Proactively drives conformance with CQI-9 requirements and continuous improvement
• Accountability: Demonstrates ability to take responsibility and maintains sense of ownership and follow through on commitments. Sets high standards of performance.
• Communication: Demonstrates ability to convey and distribute information effectively and encompass strong speaking, presentation, written and listening skills. Ability to create an environment for open communication, and communicates clearly across departments regarding heat treat and compliance status
• Teamwork: Demonstrates ability to work well with others to accomplish common goals and build a positive climate and trusting relationships within teams.
• Leadership: Demonstrates ability to give direction, motivate, manage and reward performance, provide constructive feedback and foster individual professional development. Trains and guides operators to follow standard operating procedures and compliance guidelines
• Reliability: Demonstrates dependability, accountability and trust. Follows processes and meets commitments. Delivers consistent process performance and regulatory documentation
• Decision-making: Demonstrates ability to discover opportunities in challenges, seek profit and sustainable growth, make courageous while sound decisions and demonstrate a good business understanding. Applies analytical skills and CQI-9 knowledge to make data-driven decisions

KNOWLEDGE, SKILLS & ABILITIES:

• Thorough understanding of heat treatment principles, metallurgy, and thermal processing equipment
• Working knowledge of CQI-9 audits, checklists, gap closures, and AIAG documentation practices
• Familiarity with control system troubleshooting, PLCs, HMIs, and data logging
• Ability to supervise, mentor, and train heat treat personnel on compliance, safety, and process controls
• Skilled in conducting microstructure analysis and hardness testing to validate process results
• Strong organizational and record-keeping skills for always maintaining audit-readiness
• Proficiency in Lean Manufacturing, 5S, and Continuous Improvement
• Physically capable of working in a high-temperature, industrial environment
• Commitment to upholding process integrity and product conformance to specification

WORKING ENVIRONMENTAL CONDITIONS:

• Work involves exposure to high-temperature equipment, hot surfaces, and industrial environments. May encounter fumes, noise, and moving machinery. Personal protective equipment (PPE), including heat-resistant gloves, face protection, and hearing protection, is required. Occasional exposure to quenchants, chemicals, and elevated platforms is expected. Safety training and environmental awareness are critical components of the role.

SUPERVISORY RESPONSIBILITY:

• This role has direct supervisory responsibilities.

The demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

QUALIFICATIONS:

• Bachelors degree in Mechanical, Materials, Metallurgical, or Manufacturing Engineering required.
• Materials Science or Metallurgical Engineering preferred
• 7+ years of hands-on heat treat or metallurgical experience, preferably in automotive or aerospace manufacturing
• Demonstrated knowledge and application of CQI-9 Heat Treat System Assessment requirements
• Familiarity with AIAG standards and automotive core tools (APQP, PPAP, FMEA, SPC, MSA)
• Experience conducting and documenting SAT, TUS, and other pyrometry-related activities
• Experience operating batch and continuous furnaces, quench systems, and thermal processing equipment
• Demonstrates ability to directly supervise lab personnel including assigning work, evaluating performance, managing corrective actions, and developing team capabilities.
• Creates accountability, enforces standards, and drives measurable performance improvements.
• Proficient in hardness testing, blueprint reading, GD&T, and metallurgical inspection techniques
• Strong computer skills including Microsoft Office and plant data collection systems
• Excellent troubleshooting, documentation, and analytical skills
• Commitment to safety, quality, and environmental standards
• Ability to lead and train team members on technical and compliance-related topics
• Ability to work independently, manage multiple tasks, and prioritize effectively

Compensation details: 96 Yearly Salary

PI34bc9acf25ca-26289-39818891

Hours

• Full Time 36hrs

• Friday, Saturday, and Sunday 7pm-7am

  60;

• Requires day shift weekday training for several weeks

• Competitive hourly rate + $2.00 per hour incentive pay

60;

University Hospitals is offering a $5,000 sign on bonus, minus applicable taxes, for full time certified sterile processing technicians hired externally! 60;

A Brief Overview
60;

The Sterile Processing Technician Certified role is responsible for receiving, sorting, decontaminating, reassembling, packaging, sterilizing, storing and distributing reusable patient care equipment, instrument trays and supplies.

What You Will Do
60;

• Performs decontamination procedure
• Prepares reusable patient care items for sterilization
• Sterilization using appropriate sterilization methods
• Picks surgical case carts, stores and distribute reusable patient care equipment, instrument trays and supplies
• Participates as a productive member of the O.R. processing team
• Maintains positive relationships with patients, customers, and co-workers
• Participates as a productive member of the perioperative process team

Additional Responsibilities
60;

• Performs other duties as assigned.
• Complies with all policies and standards.
• For specific duties and responsibilities, refer to documentation provided by the department during orientation.
• Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.

• High School Equivalent / GED (Required) and
• Graduate of a Sterile Processing (Preferred)

• Previous hospital central service instrument decontamination and chemical, assembly, inventory or distribution experience. (Preferred)

• Basic medical terminology. (Preferred proficiency)
• Steam, EtO, Plasma, Peracetic Acid, Dry Heat, and liquid sterilants. (Required proficiency)
• Knowledge of: Equipment, sterilizers, washers, instruments, and tray assembly. (Required proficiency)
• Good manual dexterity. (Required proficiency)
• Attention to details. (Required proficiency)

• National or International Sterile Processing Technician Certification through CBSPD or IAHCSMM. (Required)

• Standing Frequently
• Walking Frequently
• Sitting Rarely
• Lifting Frequently 50 lbs
• Carrying Frequently 50 lbs
• Pushing Frequently 50 lbs
• Pulling Frequently 50 lbs
• Climbing Occasionally 50 lbs
• Balancing Occasionally
• Stooping Frequently
• Kneeling Frequently
• Crouching Frequently
• Crawling Occasionally
• Reaching Frequently
• Handling Frequently
• Grasping Frequently
• Feeling Constantly
• Talking Constantly
• Hearing Constantly
• Repetitive Motions Constantly
• Eye/Hand/Foot Coordination Constantly

• 10%

Triumvirate Environmental, one of the largest environmental services firms in North America, is seeking an (onsite) Processing Machine Operator for our Pennsylvania recycling operation. This position reports to Production Supervisor. The schedule is Monday through Friday, 4:00pm-2:30am.

This safety sensitive, detail oriented, and highly motivated individual will be responsible for operating different types of shredders and grinders. They will also be working closely with compounding (densifying) equipment.

Triumvirate Environmental provides leading organizations in the higher education, life sciences, healthcare, and advanced manufacturing sectors with diverse services and expertise to assist them with compliance management. At Triumvirate Environmental, we strive to WOW both our employees and our customers. Our unique culture fosters growth, development, education, and creativity.

Triumvirate Environmental is committed to social responsibility, focusing on environmental protection, sustainable development, and improving access to education and healthcare. Through our products, services, and corporate initiatives, we strive to make a positive impact, going beyond compliance to promote social good. Our dedication to sustainability and ethical standards drives our long-term success and strengthens relationships with stakeholders.

Essential Responsibilities:

• Identify and label different types of material properly.
• Use basic and power hand tools to remove unwanted metal and plastic from recycled plastics.
• Help drive sustainability by sorting different types of plastic and separating them to be used in the extrusion process.
• Identify when material is not melting properly, adjust temperatures, screw speed and ram settings as needed on compounder machines.
• Regular/Daily cleaning of work area and tools.
• Work efficiently and productively.
• Ability to multi-task.
• Stack material in a safe and efficient manner.
• Develop an understanding of OSHA regulations and Triumvirate's Health and Safety Practices.
• Respect and build a working relationship with co-workers.
• Must successfully complete on-the-job training.
• Ability to stand 8+ hours per day.
• Must be able to lift-up to 50lbs repetitively.
• Must be able to operate a forklift.
• Other duties as assigned.

Basic Requirements:

• High School diploma or equivalent.
• Ability to operate large precision shop machinery.
• Strong aptitude in problem solving and process improvement.
• Demonstrate the ability to articulate problems and solutions.
• Demonstrate a sense of urgency and personal initiative related to problem resolution duties with follow-through and professionalism.
• Self-motivated and capable of managing stressful situations.
• Must demonstrate a strong commitment to safety.
• Collaborate effectively with team members.
• Demonstrate openness to learning by adapting to new processes, incorporating constructive feedback, and taking initiative to develop skills and expertise.
• Must be able to lift 50 pounds repetitively.
• Ability to work overtime.
• This role is considered safety sensitive.
• Must have a reliable form of transportation.
• Must be eligible to work in the United States without future sponsorship.

Preferred Requirements:

• Previous manufacturing experience.
• Previous forklift experience.
• Manufacturing experience.
• Detail oriented.
• Works well with a team.
• Takes direction/criticism positively.
• Willingness to learn.

Work Environment:

• Manufacturing environment where hearing protection, safety glasses and steel toed boots are required.
• Large facility with approximately 100,000 square feet of ground to cover.
• Seasonal variation in temperature and weather conditions.
• Frequent radio communication with operators and managers.
• Teamwork-centered atmosphere with over 100 employees.

Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

Besides Health, Dental and Vision Insurance, we contribute to a 401k, offer a generous tuition reimbursement program, TONS of safety training for some positions with opportunities for external trainings and certifications, Mentorship & Career Succession Planning, Relocation Opportunities, Auto/Home insurance discounts, pet assistance discount plans, discounted movie passes & more!

Triumvirate Environmental is committed to a diverse and inclusive workplace. As an Equal Opportunity Employer (EOE), Triumvirate does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Individuals with Disabilities and Protected Veterans are encouraged to apply.

If you have a disability and need accommodation during the application and hiring process, please contact us at https:///contact or call us at 888-834-9697. The requirements listed above are representative of the knowledge, skill, and/or ability required. To view our California Privacy Notice and Policy, click here.

Pay Range: $19 - $20 USD

At STERIS, we are dedicated to creating a healthier and safer world through innovative healthcare and life science solutions. As industry experts in sterile processing, our teams process over 150 million instruments annually for our customers. We are looking for a dynamic and experienced Senior Manager, Sterile Processing to join our team and lead our facility's production and quality efforts. As a Senior Manager Sterile Processing, you'll oversee production and quality performance across outsourced facilities and customer accounts. You'll be the driving force behind ensuring customer satisfaction by proactively managing daily operations, meeting contractual obligations, and upholding the highest standards in sterile processing. You'll provide on-site support, training, and strategic communication to both internal teams and client facility staff. You'll ensure strict compliance with regulatory standards from the Department of Health, TJC, DNV, OSHA, CDC, AAMI, and AORN. Leveraging your expertise in process improvement, you'll lead impactful initiatives using STERIS Process Improvement (PI) modules, driving efficiency, safety, and service excellence across all operations.

This is an onsite role based in Chicago, IL.

What you'll do as a Senior Manager Sterile Processing:

Lead and inspire a high-performing leadership team to deliver exceptional day-to-day service that meets customer needs, contractual obligations, and business goals.

Build and maintain strong relationships with customers at all levels, including executive leadership, ensuring satisfaction through regular KPI reviews, pulse checks, and bi-annual business reviews.

Proactively resolve customer issues by identifying root causes, implementing corrective action plans, and tracking measurable outcomes.

Collaborate with STERIS Business Development and internal teams to identify growth opportunities, support contract changes, and expand service offerings.

Ensure full compliance with all regulatory standards (DOH, TJC, DNV, OSHA, CDC, AAMI, AORN) and facility policies across all operations.

Oversee staffing strategies, aligning resources with fluctuating demand and ensuring leadership is equipped to do the same.

Foster a culture of employee engagement, retention, and safety through ongoing communication, training, and development.

Manage recruitment, onboarding, coaching, and performance management to build a skilled and motivated team.

Drive continuous improvement by leading process improvement initiatives using STERIS PI modules and coaching others in PI methodology.

Ensure accurate and timely completion of all administrative functions, including documentation, billing, inventories, and time records.

Effectively manage P&L responsibilities, ensuring financial targets are met while delivering high-quality service.

Implement new policies, procedures, and services in alignment with contracts and STERIS standards to enhance customer experience.

Collaborate across STERIS operations, service, and finance teams to support business objectives, manage invoicing, and ensure accurate financial reporting.

The Experience, Skills, and Abilities Needed:

High School Diploma

10 years of experience in Sterile Processing and 5 years of Sterile Processing leadership

CRCST or CBSPD Certification. If not certified at point of hire, certification must be obtained within 12 months of hire.

Must be able to be compliant with hospital/customer credentialing requirements.

Preferred Experience:

Bachelor's degree

Leadership experience supporting a minimum of 20 Operating Rooms

Pay range for this opportunity is $113,900.00 - $147,400.00. This position is eligible for bonus participation.

Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.

STERIS offers a comprehensive and competitive benefits portfolio.

STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.

About the Role

The Sterile Processing Technician plays a vital role in ensuring the safety and efficiency of surgical services. This position manages the full reprocessing cycle for surgical instrumentation, including disassembly, decontamination, disinfection, inspection, testing, assembly, packaging, high-level disinfection, and sterilization.

Key Responsibilities

• Operate ultrasonic cleaners, washers, sterilizers, and related equipment.
• Conduct quality monitoring and documentation.
• Prepare case carts with instruments and supplies for surgery.
• Perform quality assurance checks and maintain supply inventory.
• Mentor and train new technicians, promoting teamwork and excellence.

Main Benefits

• Challenging and rewarding work environment
• Growth and Development Opportunities within UHS and its Subsidiaries
• Competitive Compensation
• $100 monthly commute subsidy
• Excellent Medical, Dental, Vision and Prescription Drug Plan
• 401k plan with company match

About GW Hospital

The George Washington University Hospital is a 395-bed tertiary care, academic medical center located in downtown Washington, DC. Featuring a Level I Trauma Center and a Level III NICU, GW Hospital offers clinical expertise in a variety of areas, including cardiac, cancer, neurosciences, womens health, and advanced surgery, including robotic and minimally invasive surgery. The mission of GW Hospital is to provide the highest quality health care, advanced medical technology and world-class service to its patients in an academic medical center dedicated to education and research. For more information, visit . Physicians are independent practitioners who are not employees or agents of The George Washington University Hospital. The hospital shall not be liable for actions or treatments provided by physicians.

• High School diploma or equivalent.
• Minimum two years of sterile processing experience as a certified SPD Tech.
• CRCST or equivalent certification (CSPDT). Additional certifications preferred.
• Strong communication, organization, and critical-thinking skills.
• Familiarity with Microsoft Office and instrument management systems (Censis, OneSource).

About Universal Health Services: One of the nations largest and most respected providers of hospital and healthcare services, Universal Health Services, Inc. (NYSE: UHS) has built an impressive record of achievement and performance. Growing steadily since its inception into an esteemed Fortune 300 corporation, annual revenues were $15.8 billion in 2024. During the year, UHS was again recognized as one of the Worlds Most Admired Companies by Fortune; and listed in Forbes ranking of Americas Largest Public Companies. Headquartered in King of Prussia, PA, UHS has approximately 99,000 employees and continues to grow through its subsidiaries. Operating acute care hospitals, behavioral health facilities, outpatient facilities and ambulatory care access points, an insurance offering, a physician network and various related services located all over the U.S. States, Washington, D.C., Puerto Rico and the United Kingdom. Statement: All UHS subsidiaries are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates. UHS subsidiaries are equal opportunity employers and as such, openly support and fully commit to recruitment, selection, placement, promotion and compensation of individuals without regard to race, color, religion, age, sex (including pregnancy, gender identity, and sexual orientation), genetic information, national origin, disability status, protected veteran status or any other characteristic protected by federal, state or local laws. We believe that diversity and inclusion among our teammates is critical to our success.

Avoid and Report Recruitment Scams: At UHS and all our subsidiaries, our Human Resources departments and recruiters are here to help prospective candidates by matching skill set and experience with the best possible career path at UHS and our subsidiaries. During the recruitment process, no recruiter or employee will request financial or personal information (e.g., Social Security Number, credit card or bank information, etc.) from you via email. Our recruiters will not email you from a public webmail client like Hotmail, Gmail, Yahoo Mail, etc. If you suspect a fraudulent job posting or job-related email mentioning UHS or its subsidiaries, we encourage you to report such concerns to appropriate law enforcement. We encourage you to refer to legitimate UHS and UHS subsidiary career websites to verify job opportunities and not rely on unsolicited calls from recruiters.

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.