Join Our Team
Working for our company presents the opportunity to work in unique, dynamic roles in the field of biotechnology. You will be immersed in cutting-edge biotech research. Business is expected to grow exponentially over the next several years. Our technologies and products help thousands of patients every year, and we strive to make a profound difference on a global stage with our scientific advancements.
Production Operations Manager | Signature Biologics, LLC
Company is looking to add a Production Operations Manager to the team, who will be essential to plan, develop, and continually improve the biotech product production and storage infrastructure in support of our strategic growth objectives to Health Care Providers while maintaining the highest adherence to company quality standards. Reports to the President.
- Oversee daily performance against established standards and schedules. Resolve workflow and processing technical issues. Support one, multiple or continual shifts to meet organization performance objectives.
- Reviews sales forecasts, supply forecasts, capacity planning with Senior Leadership. Works with other functions to ensure production and work schedules have required flow of materials, information and paperwork.
- Provide transparent raw material, WIP and finished goods inventory control, planning and forecasting.
- Assures compliance within Production with all cGTP, cGMP, ISO and safety standards.
- Manages continual improvement training and opportunity scheduling for production staff.
- Facilitates regular staff communications, trainings and employee development opportunities.
- Keeps training logs, operator qualifications and follows SOPs for all applicable regulations.
- Ensures that facility is kept “tour ready” at all times.
- Maintains people, materials, flow, cleaning and zone concepts in line with quality and production goals for the facility.
- Ensures batch, lot and serialized controls are accurate and records are accurate the first time.
- Oversees and validates all materials inputs to ERP are validated and in compliance with corporate objectives to maintain a single system of record.
- Complies with implementation of any necessary CAPA actions.
- Complete readiness and cooperation for on-site audits – scheduled and unscheduled.
- Provides feedback and collaboration with leadership team to identify continual improvement goals and implements them with management approval.
- Drives production efficiencies, lower COGs and employee retention to control operating expenditures in a rapidly growing environment.
- Excellent written, oral and electronic communication skills
- Capable of creating, working within an operating plan and framework
- Proven production and workforce scheduling software experience (ERP or HRIT Systems)
- Ability to solve complex problems quickly and communicate solutions clearly
- Exceptionally reliable, organizational and time management skills
- Working knowledge of cGMP, cGTP, OSHA, ISO, FDA guidelines and how to apply them effectively
- Ability to work independently as well as being a member of a team
- 10+ Years experience in controlled manufacturing. Biotech, Medical Device or Pharmaceuticals preferred.
- 3+ Years of supervisory or relevant management experience.
- Minimum of Bachelors in Engineering, Supply Chain Management or Scientific Discipline
- Full Time Position working in Signature Biologics Headquarters in Farmers Branch, TX
- Monday through Friday from 8am to 5pm with some night and weekend work required
To apply, please email a cover letter and resume to Chloe Bailey, President of Signature Biologics, at firstname.lastname@example.org
Laboratory Technician| Signature Biologics, LLC
Essential Duties and Responsibilities
- Be available for work from 8:00 am to 5:00 pm, each day, Monday –Saturday (except company acknowledged holiday’s). Office will open a second shift in New Year.
- Perform related duties as assigned by the Laboratory Director
- Maintain compliance with all company policies and procedures
- Must be able to install and maintain manufacturing training for new equipment or tissue process validations
- Responsible for all responsibilities and activities related to controlled area cleaning –pre/post clean and packaging as directed by the Laboratory Director.
- Responsible for keeping all company documentation, work product, controlled documents, SOP’s, specification sheets, and company Intellectual Property Confidential.
- Must be able to speak, listen and communicate in a professional manner in all aspects of job
- Perform manufacturing of products according to the established procedures.
- Participate in the annual Internal Audit procedure Assist with any issues related to consumables/disposables/ and reagents
- Review the manufacturing paperwork daily on each step of process for each donor processed prior to sending to QA for review.
Education and/or Work Experience Requirements
- Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers
- Excellent computer proficiency (MS Office – Word, Excel and Outlook)
- Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary work product
- Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard accepted practices
- Must understand global metric standard Bachelor degree in
- Biology or Life Sciences
- Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.
- Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and otherfederal, state and local standards
- Must be able to lift, carry, and move up to 50 lbs
Applications without a cover letter will not be accepted.