How to Apply:

Interested candidates should send their resume, title(s) of job for which they wish to be considered, and salary requirements to hr@origenbio.com.   Unfortunately, due to the volume of candidates, it is not possible to follow-up with all applicants, but we invite you to visit OriGen’s Career Page often, as we are updating with new opportunities frequently.  We look forward to hearing from you.

OriGen Biomedical manufactures essential, life-saving products.  As such, OriGen is an essential business and some jobs may be required to work onsite. Your health and safety is important, and while we take pride in our everyday practices to maintain a clean and sanitary environment within our facilities, at present, we have implemented additional measures that reflect the recommended standards of the Centers for Disease Control and Prevention (CDC) in response to the coronavirus.

Current Job Openings:

Buyer / Planner

Position Summary

The Buyer/Planner will perform and manage plant supply chain activities. Ensure the continuous supply of high quality, low cost raw materials efficiently to keep daily operations running, while maintaining and reporting metrics that allow us to evaluate the performance of our suppliers. Confirm materials and capacity, plan and schedule production work orders to meet master schedule requirements. Manage inventory levels of raw material and work in process and manage inbound and outbound logistics.

Essential Duties and Responsibilities

  • Review and analyze weekly requirements generated by Epicor to determine what materials should be purchased.
  • Generate and track purchase orders for raw materials in order to ensure on time delivery.
  • Review and determine the availability of materials and capacity to meet the schedule in order to ensure that the production of final products meets customer needs.
  • Verify the availability of materials, weekly, relative to the production plan and make necessary adjustments to the weekly build schedule.
  • Manage inbound and outbound logistics to optimize the lead time, transportation costs, customs and regulatory clearances.
  • Evaluate Supplier Quality (in conjunction with Quality Assurance Engineer) and Delivery Performance and provide feedback to the supply base.
  • Work with the supply base to ensure timely delivery of supplier documentation (invoices, CoCs, etc.) to ensure a smooth flow of goods through the logistics pipeline as well as Incoming Quality Assurance.
  • Manage the return of rejected products with the supply base and follow up to receive the credit for the returned product.
  • Review and approve change orders in order to determine the impact of changes on material in the warehouse, on order and work in process. Work to minimize obsolescence.
  • Maintain MRP data in Epicor to ensure that the Epicor requirements correctly generate new raw material purchases.
  • Drive improvements in quality, cost and delivery of supplied components.
  • Coordinate the inspection of first articles when needed.
  • Resolve inventory discrepancies as appropriate.
  • Comply with all requirements, duties and obligations of our Quality Management System.
  • Comply with healthy and safety initiatives, policies and procedures. Identify opportunities to improve health and safety.
  • Safeguard all documents, confidential information, equipment, tools, raw materials, products or other assets directly related to their area of ​​work.

Required Skill Sets

  • Must be proficient on computer, possessing intermediate/ advanced navigation and program knowledge
  • Must be able to absorb, assimilate and accurately recall/locate and retain large quantities of data/information
  • Must be able to read, write, speak and fully understand English

Competencies

  • Adaptability/Flexibility
  • Ethical Conduct/Integrity
  • Communication/Listening
  • Detail-Oriented
  • Interpersonal skills
  • Personal Effectiveness
  • Teamwork

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Strong organization and time management skills with the demonstrated ability to meet deadlines
  • Pays very close attention to detail
  • Ability to work independently and within a team environment

Preferred Qualifications

  • B.S. or Masters degree in Engineering or Business Administration. At least 7 years of supply chain experience. At least 5 years experience in purchasing and production planning.
  • APICS CPIM certification. Experience in logistics and warehouse operations. Medical device experience preferred.
  • Knowledge and use of Epicor.

Supervisory Responsibility

This position has no supervisory responsibilities.

Work Environment

This job often operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clean and non-frayed pants/scrubs completely covering the legs and/or a full pants/body “bunny suit”. Personnel may also be required to wear company-provided cleanroom coat, bouffant, face mask, and gloves.

  • Must be able to stand or sit for extended periods of time. Must be able to wear personal protective equipment when required.
  • Due to extremely detailed nature of work, may be required to submit to periodic post-employment vision screening and be willing/able to wear corrective eye wear if deemed necessary/appropriate.
  • Note: OriGen is a fragrance, smoke, smokeless tobacco and vape-free facility. There is NO use of any tobacco or vape products permitted anywhere on company grounds/property or during any shift, break or lunch period.

Physical Demands and Work Environment 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers. The employee is frequently required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually moderate.

Salary:

Commensurate with Experience.

Director, Regulatory Affairs

Director of Regulatory Affairs in Austin, TX

Located in Austin Texas, we are a well-established, fast-growing, medium size medical device company specializing in devices for cryopreservation and cell culture. We are currently looking for an experienced QA/RA Director to join our team.

Position Summary

The Regulatory Affairs Director is responsible ensuring compliance with global medical device regulations including CFR, ISO 13485 and MDSAP requirements. This position will manage both the Regulatory and QA staff.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Develops a forward-looking compliance program to maintain global distribution of medical devices.
  • Advocate for and work within a medium size device firm.
  • Ensures that the Quality System requirements are established and maintained as described in applicable FDA and International Standards.
  • Provide clear and concise reporting on QA and RA functions.
  • Technical writing, direction and submission of Regulatory documentation.
  • Manage and improve the Quality function through direct report supervisors.
  • Oversees Quality Assurance functions, including
    • All internal and external audits
    • CAPA, complaints and MRBs
    • Supplier assessment
    • Training programs
    • Design control
  • Maintains and updates Technical Files on company’s devices.
  • Works with other departments to integrate Regulatory and Quality requirements into all processes.
  • Assists our Distributors in meeting local regulatory requirements.
  • Leads their team to achieve deadlines on time and on budget.
  • Participates in all phases of Product Design.
  • Participates in Strategic Planning.

Competencies

  • Proven Leadership Skills
  • Intimate knowledge of Regulatory environment for medical devices, CFR, 13485. MDR
  • Cost conscious, small company attitude
  • Excellent communication and interpersonal skills
  • Superior organizational and time management skills
  • Sound decision making
  • Ethical Conduct
  • Close attention to detail
  • Broad creativity and curiosity
  • Effective problem-solving skills
  • Adaptability, can work with changing priorities

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Bachelor’s degree in Science/Math/Engineering
  • 10+ years’ experience in QA / RA in medical device manufacturing
  • 5+ years of leadership experience
  • 4+ years’ recent experience in CFR / ISO 13485 environment
  • Audit experience with FDA and Notified Bodies
  • Ability to understand and interpret customer needs; ability to work with all work functions (i.e. Regulatory, Operations, Human Resources, Engineering)
  • Ability to work independently and lead in a team environment

Preferred Qualifications

  • Masters’ degree in a related discipline
  • Professional certification preferred (ASQ CQA, CQE, C Q. Mgr, CQA-Biomedical, RAC)

Supervisory Responsibility

This position has direct supervision of a department of six. The individual may also be required to lead project teams and ensure participants meet deadlines.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
This job often operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the office environment is usually minimal.

For more information or to apply, please email a resume to Origen Jobs.  Resumes may also be submitted by fax or mail.

Line Lead - First Shift

The Clean Room Line Lead is responsible for leading and directing the CR team in assembly, testing and packaging of medical devices and components. Role is required to understand and comply with drawings, written procedures, batch records and apply these standards to their work.

As a team lead, you will be the main contact point for all team members. You will possess the ability to be a team player, team leader and are expected to timely escalate issues to management for resolution. You should lead by setting a good example and engage and motivate the team to achieve daily goals. You will oversee production processes in accordance with OriGen’s policies and procedures.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Daily CR Shift Setup:
    • Equipment inspection and start-up
    • Daily log review/completion
    • Priority assessment and assignment
    • Shift pass down – verify all paperwork is filled out before passing on
  • Report problems or concerns with quality, processes, equipment, materials and staffing to Operations Manager or designee.
  • Meet production schedules and deadlines while maintaining quality standards
  • Work in a flexible and changing environment
  • Communicate, delegate and motivate in a positive manner
  • Lead and motivate team members to meet production goals
  • Follow detailed written and verbal instructions
  • Aid in training members on assembly processes and answers related questions from team
  • Effectively communicate daily concerns and issues with others and management during shift and at shift change
  • Learn multiple tasks and train in other areas as needed
  • Work with a variety of tools and equipment
  • Maintain all logs, paperwork and forms accurately
  • Understand, access and make entries to documents on the company Electronic Document System
  • Accurately perform job duties with minimum supervision
  • Adhere to cleanroom dress code and policies
  • Work in a multi-cultural team environment and be a team player
  • Work in a cleanroom environment for extended periods of time
  • Must be punctual, reliable and willing to lead by example

Required Skill Sets

  • Detailed oriented and able to focus on repetitive tasks for long periods of time
  • Proficient on computer; possessing basic navigation and program knowledge
  • Able to absorb, assimilate and accurately recall/locate and retain large quantities of data/information
  • Must be able to read, write, speak and fully understand English

Competencies

  • Adaptability/Flexibility
  • Ethical Conduct/Integrity
  • Communication/Listening
  • Detail-Oriented
  • Interpersonal skills
  • Personal Effectiveness
  • Teamwork/Team Leadership

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Basic computer navigation and program knowledge
  • Strong organization and time management skills with the demonstrated ability to meet deadlines
  • Close attention to detail
  • Ability to work independently and within a team environment
  • Prior Clean Room experience

Preferred Qualifications

  • Prior experience in a lead position is preferred

Supervisory Responsibility

This position has no direct supervisory responsibilities although the role will be responsible for daily work/task assignment and oversight.

Work Environment

This job often operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clean and non-frayed pants/scrubs completely covering the legs and/or a full pants/body “bunny suit”. Personnel may also be required to wear company-provided cleanroom coat, bouffant, face mask, and gloves.

  • Must be able to stand or sit for extended periods of time. Must be able to wear personal protective equipment when required.
  • Due to extremely detailed nature of work, may be required to submit to periodic post-employment vision screening and be willing/able to wear corrective eye wear if deemed necessary/appropriate.
  • Note: OriGen is a fragrance, smoke, smokeless tobacco and vape-free facility. There is NO use of any tobacco or vape products permitted anywhere on company grounds/property or during any shift, break or lunch period.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is frequently required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the work environment is usually moderate.

Compensation

Based on experience and ability

Sales Development Representative

Position Summary

The Sales Development Representative is tasked with identifying and generating sales opportunities through both inbound and outbound calling activities. The right candidate will be one who works well under pressure, thinks out-of-the-box, easily initiates relaxed but informative two-way phone conversations with prospects, and is highly self-motivated. The right candidate will also understand how to assess a company’s needs and cater the outreach to each prospect specifically.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Follow-up on inbound marketing leads and identify qualified opportunities providing appropriate levels of information at the right time for interested prospects
  • Be responsible for educating and developing prospects leading to hand-off to sales teams
  • Create target prospects lists and penetrate key accounts
  • Cold call into prospects generated by variety of outside sources
  • Serve as subject matter expert, demonstrating OriGen knowledge and emphasizing value to clients
  • Identify key players, researching and obtaining business requirements, and presenting solutions to begin sales cycle
  • Profile strategic accounts identifying key individuals, researching and obtaining business requirements and presenting solutions to start the sales cycle
  • Set appointments for sales team when a lead reaches a qualified stage
  • Nurture new marketing leads by educating and developing prospects until they are ready to speak with field sales
  • Drive attendance for webinars and live seminars, set meetings for conferences
  • Collaborate with sales and marketing team members on strategic sales approach and identify new business opportunities
  • Ensure successful follow through of sales cycle by maintaining accurate activity and lead qualification information in SalesForce CRM
  • Developing sales strategies to draw in potential buyers or to solicit new potential customers
  • Initiating contact with potential customers through cold-calling or responding to inquiries generated from marketing, industry events, and other lead generating activities
  • Creating relationships with customers to identify their potential needs and qualify their interests and viability to drive sales
  • Presenting product information to customers once you have identified their needs
  • Moving solid leads through the sales funnel, connecting them to a salesperson, and arranging in-person meetings, emails, or phone calls
  • Following-up with potential customers who expressed interest but did not purchase any goods or services
  • Performing regular follow-up calls or emails and facilitating communication with existing customers to ensure their satisfaction and identify new potential needs
  • Collaborating with sales leadership to ensure the company’s goals and targets are met

Competencies

  • Financial Management
  • Self-starter
  • Strategic Thought
  • Innovation
  • Adaptability
  • Results-driven
  • Technical Capacity
  • Ethical Conduct
  • Communication
  • Decision making
  • Interpersonal skills

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • High School diploma and some post-secondary education in Sales, Marketing, Business, or related field
  • 3+ year of successful experience in telemarketing, preferably in Cell Therapy, Biotech, or related industry
  • Exceptional communication skills, both oral and written, coupled with excellent listening skills and a positive and energetic phone presence
  • Demonstrated success in prospecting
  • Extremely self-motivated with a diligent work ethic
  • High level of integrity and strong commitment to building a successful company
  • Ability to work independently as well as part of a team in a fast-paced environment
  • Adept computer skills including proficiency with Microsoft Office and Google Workspace (formerly G-Suite)
  • Experience with SalesForce or other CRM software
  • Experience with ERP programs
  • Bachelor’s degree preferred, high school diploma or equivalent required
  • Good time management and analytical skills
  • Good telephone etiquette and computer literacy skills
  • Has worked collaboratively with the sales team to generate leads and identify new business opportunities
  • Capability of understanding customer pain points and applying that knowledge in value-add opportunities
  • Ambitious self-starter that can effectively process inbound inquiries
  • Strong and professional presentation skills
  • Promotes a strong sense of urgency for reaching goals and key deliverables
  • Contributes fully to the team effort and plays an integral part in the smooth running of teams without necessarily taking the lead
  • Drive, Grit, Team Oriented: strong desire to compete and win

Preferred Qualifications

  • A Bachelor degree in Sales, Marketing, Business, or related field
  • 1-3 years professional experience as a Sales Development Representative
  • 1+ year of successful experience in telemarketing, preferably in Cell Therapy, Biotech, or related industry

Supervisory Responsibility

This position has no supervisory responsibilities; however, the individual may be required to lead projects and ensure participants meet deadlines.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
This job often operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the work environment is usually moderate.

Salary:

Commensurate with Experience 

For more information or to apply, please email a resume to Origen Jobs.  Resumes may also be submitted by fax or mail. Click here  for our contact information.

Cleanroom Tech for Medical Device Production - Morning and Evening Shift

Morning Shift: Work hours: five days, 8 hour shifts (Monday-Friday 5:45am – 2:15pm).

Evening Shift: Work hours: four days, 10 hour shifts (Monday-Thursday  2:15pm – 12:45am). 

The Clean Room Tech (CRT) is responsible for: assembly, testing and packaging of medical devices and components. Required to understand and comply with drawings, written procedures, batch records and apply these standards to their work.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Ability to meet production schedules and deadlines according to quality standards
  • Ability to work in a flexible and changing environment
  • Ability to follow detailed written and verbal instructions
  • Ability to learn multiple tasks and train in other areas as needed
  • Ability to work with a variety of tools and equipment
  • Ability to maintain all logs, paperwork and forms accurately
  • Required to understand, access and make entries to documents on the company Electronic Document System
  • Ability to accurately perform job duties with minimum supervision
  • Ability to adhere to cleanroom dress code and policies
  • Ability to work in a multi-cultural team environment and be a team player
  • Ability to work in a cleanroom environment for extended periods of time
  • Punctual and Reliable!!

Required Skill Sets

  • Must be detailed oriented and be able to focus on a repetitive task for long periods of time
  • Must be proficient on computer, possessing basic navigation and program knowledge
  • Must be able to absorb, assimilate and accurately recall/locate and retain large quantities of data/information
  • Must be able to read, write, speak and fully understand English

Competencies

  • Adaptability/Flexibility
  • Ethical Conduct/Integrity
  • Communication/Listening
  • Detail-Oriented
  • Interpersonal skills
  • Personal Effectiveness
  • Teamwork

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Basic computer navigation and program knowledge
  • Strong organization and time management skills with the demonstrated ability to meet deadlines
  • Pays very close attention to detail
  • Ability to work independently and within a team environment  

Preferred Qualifications

  • Prior Clean Room experience preferred

Compensation

Based on experience and ability